sop of production department

SARTHAK BIOTECH Pvt. Ltd.198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE INDEX OF PRODUCTION SOP’S Sr. No NAME OF THE SOP Category/ SOP No. 1. SOP FOR PREPARATION OF SANITIZING SOLUTION SPD/01 2. SOP FOR RODENTS, INSECTS & BIRDS CONTROL IN PRODUCTION SPD/02 3. SOP FOR CLEANING AND OPERATION OF AIR HANDLING UNIT PRE FILTERS SPD/03 4. SOP FOR DISPOSAL OF EXPIRED FINISHED GOODS SPD/04 5. SOP FOR BUILDING MAINTENANCE SPD/05 6. SOP FOR DISPOSAL OF EXCESS/ REJECTED PACKING MATERIAL SPD/06 7. SOP FOR ENTRY/ EXIT OF VISITORS IN MANUFACTURING AREA SPD/07 8. SOP FOR ENTRY INTO PRODUCTION AREA SPD/08 9. SOP FOR SAFETY PRACTICES SPD/09 10. SOP FOR LOG BOOK SYSTEM SPD/10 11. SOP FOR ENVIRONMENT MONITORING SPD/11 12. SOP FOR REMOVAL OF SCRAP FROM PRODUCTION AREA SPD/12 13. SOP FOR DISPOSAL OF EMPTY CONTAINERS SPD/13 14. SOP FOR CLEANING OF GENERAL DRESSES SPD/14 15. SOP FOR CLEANING AND SANITATION OF GENERAL AREA PRODUCTION BLOCK SPD/15 16. SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCE SPD/16 17. 18. SOP FOR CLEANING AND OPERATION OF MANUAL CAPSULE FILLING MACHINE SOP FOR CLEANING AND OPERATION OF BLISTER PACKING MACHINE SPD/17 SPD/18 19. SOP FOR CLEANING AND OPERATION OF DOUBLE CONE BLENDER SPD/19 20. SOP FOR CLEANING AND OPERATION OF DRY FILLING MACHINE SPD/20 21. SOP FOR CLEANING AND OPERATION OF ROPP CAP BOTTLE SEALING MACHINE SPD/21 22. SOP FOR DECARTONING OF CONTAINERS AND CLOSURES SPD/22 23. SOP FOR CONTROLLING MICROBIAL CONTAMINATION (OINTMENT SECTION) SPD/23 24. SOP FOR PROCEDURE FOR LINE CLEARANCE ( PACKING) SPD/24 25. SOP FOR VISUAL INSPECTION SPD/25 26. SOP FOR BATCH CODING SPD/26 Rmk SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 27. SOP FOR REPROCESSING OF RECOVERY SPD/27 28. SOP FOR LEAK TEST FOR CAPSULES/ TABLETS (STRIP AND BLISTER PACKING) SPD/28 29. SOP FOR CLEANING & OPERATION OF CAPSULE LOADER SPD/29 30. SOP FOR CLEANING & OPERATION OF DEHUMIDIFIER SPD/30 31. SOP FOR CLEANING & OPERATION OF STRIP PACKING MACHINE SPD/31 32. SOP FOR CLEANING & OPERATION OF SIFTER SPD/32 33. SOP FOR HANDLING OF FINISHED PRODUCTS IN STORE SPD/33 34. SOP FOR PACKING OPERATION SPD/34 35. SOP FOR CLEANING OF PASTE KETTLE SPD/35 36. 37. 38 SOP FOR GENERAL CLEANING OF EQUIPMENT IN MANUFACTURING AREA SOP FOR ADVERSE HEALTH CONDITION OF PERSON IN MANUFACTURING AREA SOP FOR INTERNAL LABELING DURING QUARANTINE, STORAGE AND PROCESSING SPD/36 SPD/37 SPD/38 39. SOP FOR RECEIPT OF PACKING MATERIAL IN PRODUCTION SPD/39 40. SOP FOR DISPOSAL & SALVAGE OF REJECTED / EXPIRED / UNUSABLE MATERIALS SPD/40 41. SOP FOR THE WASTE COLLECTION FROM PRODUCTION AREA SPD/41 42. SOP FOR CLEANING OF CONVENTIONAL COATING PAN SPD/42 43. SOP FOR CLEANING OF FLUIDIZED BED DRYER SPD/43 44. SOP FOR CLEANING AND OPERATION OF MULTIMILL SPD/44 45. SOP FOR CLEANING OF POLISHING PAN SPD/45 46. SOP FOR CLEANING AND OPERATION OF CAPSULE FILLING MACHINE (SEMI AUTO MATIC) SPD/46 47. SOP FOR CLEANING OF SPRAY GUN SPD/47 48. SOP FOR CLEANING OF TABLET DEPARTMENT SPD/48 49. SOP FOR PASTE PREPARATION VESSEL SPD/49 50. SOP FOR DISPOSAL OPERATION IN TABLET DEPARTMENT SPD/50 51. SOP FOR CLEANING & ASSEMBLING OF COMPRESSION MACHINE SPD/51 52. SOP FOR TABLET COMPRESSION TOOLING SPD/52 53. SOP FOR STORAGE OF IN-PROCESS TABLETS & GRANULES SPD/53 54. SOP FOR OPERATION OF FLUIDIZED BED DRYER SPD/54 55. SOP FOR CLEANING AND OPERATION OF MASS MIXER SPD/55 SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 56. SOP FOR TABLETS INSPECTION SPD/56 57. SOP FOR HOUSE KEEPING IN TABLET COMPRESSION SECTION SPD/57 58. SOP FOR HOUSE KEEPING IN TABLET PACKING AREA SPD/58 59. SOP FOR CLEANING OF MANUFACTURING VESSEL (TOPICAL SECTION) SPD/59 60. SOP FOR CLEANING OF BULK TANK (TOPICAL SECTION) SPD/60 61. SOP FOR CLEANING AND ASSEMBLING OF TUBE FILLING MACHINE (TOPICAL SECTION) SPD/61 62. SOP FOR POLISHING OF CAPSULES SPD/62 63. SOP FOR CLEANING OF S.S. WAX MELTING VESSEL (TOPICAL SECTION) SPD/63 64. SOP FOR POLISHING OF PUNCHES AND DIES SPD/64 65. 66. 67. SOP FOR CLEANING OF UTENSILS, SCRAPPER,SPOONS & SCOOPS (TOPICAL SECTION) SOP FOR REMOVAL OF BULK FROM TUBE FILLING MACHINE SPD/65 SPD/66 (TOPICAL SECTION) SOP FOR IN-PROCESS CONTROL IN MANUFACTURING (TOPICAL SPD/67 SECTION) 68. SOP FOR HOUSE KEEPING IN TOPICAL SECTION SPD/68 69. SOP FOR INSTALLATION OF NEW PUNCH SET SPD/69 70. SOP FOR IN-PROCESS PACKING ( TOPICAL SECTION) SPD/70 71. SOP FOR LINE CLEARANCE (TOPICAL SECTION) SPD/71 72. SOP FOR CLEANING OF S.S. WATER VESSEL (TOPICAL SECTION) SPD/72 73. SOP FOR IN-PROCESS FILL WEIGHT DETERMINATION SPD/73 74. SOP FOR LABELLING & PACKING OF ORAL LIQUID SPD/74 75. SOP FOR CLEANING OF GENERAL UTENSILS, SS CONTAINERS SPD/75 SOP FOR CLEANING OF MANUFACTUIRNG AREA (TABLET, CAPSULE & 76. LIQUID ORALS) SOP FOR CLEANING OF S.S. CONTAINERS, PRESSURE VESSELS, 77. TANKS & STIRRER 78. SOP FOR CLEANING OF CONVEYOR BELT S.S. SPD/76 SPD/77 SPD/78 79. SOP FOR OPERATION & CLEANING OF BOTTLE FILLING MACHINE SPD/79 80. SOP FOR OPERATION & CLEANING OF BOTTLE WASHING MACHINE SPD/80 81. SOP FOR OPERATION & CLEANING OF COLLOIDAL MILL SPD/81 82. SOP FOR OPERATION & CLEANING OF HIGH SPEED STIRRER SPD/82 83. SOP FOR OPERATION & CLEANING OF FILTER PRESS SPD/83 84. SOP FOR OPERATION & CLEANING OF PP CAP SEALING MACHINE SPD/84 SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 85. SOP FOR VISUAL INSPECTION OF LIQUID ORALS SPD/85 86. SOP FOR CLEANING OF S.S. TANKS & STIRRER (LIQUID SECTION) SPD/86 87. SOP FOR MIXING, GRANULATION & PUNCHING SPD/87 88. SOP FOR STRIP VISUAL INSPECTION SPD/88 SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION 89. MACHINE (ROTARY MACHINE) SOP FOR OPERATION AND CLEANING OF TABLET COMPRESSION 90. MACHINE (MULTI PUNCHING MACHINE) SOP FOR OPERATION OF TUBE FILLING , SEALING ,CLEANING, SPD/89 SPD/90 91. CRIMPING & BATCH CODING MACHINE (TOPICAL SECTION) 92. SOP FOR INSPECTION, CLEANING & PACKING OF TUBES SPD/91 93. SOP FOR BATCH DESTRUCTION SPD/93 94. SOP FOR CLEANING & OPERATION OF PLANETARY MIXER SPD/94 SOP FOR CLEANING, OPERATION & MAINTENANCE OF COLLOIDAL 95. MILL. SOP FOR WASHING & CLEANING OF EQUIPMENTS (EXTERNAL 96. PREPARATION SECTION) 97. SOP FOR BATCH PREPARATION OF EXTERNAL PREPARATION SOP FOR WASHING, CLEANING & STORAGE OF EQUIPMENT, VESSELS, SPD/92 SPD/95 SPD/96 SPD/97 98. & STIRRER MACHINE PARTS FOR OINTMENT & CREAM. 99. SOP FOR COATING PAN SPD/98 100. SOP FOR TRANSFER OF FINISHED GOODS TO FINISHED GOODS STORE SPD/100 101. SOP FOR OPERATION AND CLEANING OF TRAY DRIER SPD/101 102. SOP FOR OPERATION AND CLEANING OF ALU-ALU PACK MACHINE SPD/102 103. SOP FOR OPERATING OF AIR COMPRESSOR SPD/103 104. SOP FOR OVER PRINTING ON STRIPS SPD/104 105. SOP FOR LEAKAGE CHECKS IN FILLED BOTTLE SPD/105 106. SOP FOR OVER PRINTING ON BOXES AND LABELS SPD/106 SPD/99 TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTION Page : 01-02 Deptt.: PRODUCTION SOP NO. : SPD/01 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE Sign.…………… Sign.…………………. Sign.…………...… Sign.…….………. 1) PURPOSE : To lay down a Procedure for Preparation of Sanitizing Solution. Q/C Manager. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.A. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. 5) PROCEDURE : 5.1 Preparation of Sanitizing Solution 5.1.1 70% Isopropyl Alcohol in D. M. water. Take 700ml IPA in a measuring cylinder. Add sufficient quantity of D.M.water to make 1.0-Liter solution. 5.1.2 2% Savlon solution in D.M water. Take 20ml Savlon Solution in a measuring cylinder and make 1.0 liter using DM water. 5.1.3 2% Dettol solution in D M water Take 20ml Dettol Solution in a measuring cylinder and make 1.0 liter using DM water. 5.1.4 5% Phenol solution in DM water. Heat the bottle containing Phenol in a water bath till it melts.Take 50ml liquified Phenol in a measuring cylinder and make volume up to 1.0 liters by using DM water. TITLE: SOP FOR PREPARATION OF SANITIZING SOLUTION Page : 02-02 Deptt.: PRODUCTION SOP NO. : SPD/01 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE Sign.…………… Sign.…………………. Sign.…………...… Sign.…….………. 5.1.5 4% v/v Hydrogen Peroxide solution in Distilled water Take 40 ml Hydrogen Peroxide in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters. 5.1.6 2% v/v Benzalkonium Chloride solution in Distilled water Take 20ml Benzalkonium Chloride in a measuring cylinder and add distilled water to it to make up the volume 1.0 liters. 5.1.7 2% v/v Glyceraldehyde solution in Distilled water’ Take 20ml Glyceraldehyde in a measuring cylinder and add distilled water to make volume 1.0 liters. Note: All these preparations are prepared in third air lock. 5.2 Precaution: Wear Gloves, Mask & Goggles before preparing sanitizing solution. TITLE: SOP FOR RODENTS, INSECTS & BIRDS CONTROL Page : 01-01 IN PRODUCTION Deptt.: PRODUCTION SOP NO.: SPD/02 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director redents and insects by applying the chemical. one with wire mesh. For insect control.………………….: PRODUCTION SOP NO. Production Chemist Production Manager Q.. Sign.… Sign. Ltd.2 Entries doors are installe with are Curtains to avoid entry of insects. company has placed at all the entry-exit place. 1) PURPOSE: To lay down procedure of control of rodents.……….) STANDARD OPERATING PROCEDURE Sign... insects and birds to be carried out by the approved contractor.SARTHAK BIOTECH Pvt. Manager Director . nets sieves repellents i. door nets are fixe on all entries.: SPD/03 Effective Date: 15-07-2007 Revision No.1 The approved contractor is deputing for control of birds. flycatcher. 5.e.. other with wooden & glass doors.A. with the facility of door closer. Birds repellents.. TITLE: SOP FOR CLEANING & OPERATION OF AIR Page : 01-01 HANDLING UNIT PRE FILTERS Deptt. 198-A. HSIIDC.……. KARNAL-132 001 (HR.A. 4) SCOPE: The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. UV repellent (blue light). Sector-3. 5. 5) PROCEDURE: 5. double door.……….. Manager 3) ACCOUNTABILITY: Production Manager/ Q A Manager. Ltd. 2) RESPONSIBILITY: Q.3 The contractor come twice every month or whenever called to review the situation.…………… Sign. Karnal.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Q/C Manager.A.: SPD/04 Effective Date: 15-07-2007 Revision No. Ltd. KARNAL-132 001 (HR. CLEANING: 6. 6. 5. 6. 6. 198-A. 6.: PRODUCTION SOP NO. TITLE: SOP FOR DISPOSAL OF EXPIRED FINISHED Page : 01-01 GOODS Deptt. 6. Manager Director .SARTHAK BIOTECH Pvt. 5 PROCEDURE : 1) To lay down a Procedure for Cleaning and Operation of Air Handling Unit Pre-Filters.A. 6..……….7 Pass the compressed air through the other side of the filter and then dry the filter. Manager 4 SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt..weakly off day. Sign. 6. 1 PURPOSE : 2 RESPONSIBILITY : 3 ACCOUNTABILITY : Production Manager/Q. Ltd.1 Before cleaning of the AHU pre-filter.4 Close the AHU filter cabinet with poly bag till the filter is ready to be fixed.3 Remove the filter cabinet set aside.………. 6.… Sign.2 Cleaning of pre-filter cabinet is carried out side of the production area.……………………. Karnal. switch OFF the mains. out side the production area. 6. Production Chemist Production Manager Q..) STANDARD OPERATING PROCEDURE Sign.6 Wash the pre-filters using mild soap solution and then with running tap water.e. .5 Clear the filter by compressed air at least for five times with airflow in reverse of the operational flow direction.10 Fix the pre-filter and tight cabinet bolts.1 Cleaning of pre-filter 20 micron average 7-15 days i. 5.8 Remove the poly bag from dust.… Sign.2 Loosen the filter cabinet bolts.…….11 Record the cleaning operation of pre-filters in prescribed format. 6.. HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.9 Clean the filter cabinet with dry clothes. Sector-3.…………………. Karnal. the same is recorded. Q/C Manager.……. Sign. Manager Director .. TITLE: SOP FOR BUILDING MAINTENANCE Page : 01-02 Deptt.SARTHAK BIOTECH Pvt.3 Disposal done under supervision of Q.2 In case of Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment. 5. PRECAUTIONS : 6. KARNAL-132 001 (HR. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. 198-A.……….1 Expired finished materials are not used for medicinal purpose. Sector-3.. 6.4 Poisonous or obnoxious materials are treated to neutralization before dumping.A.5 After disposal of the material.………. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.) STANDARD OPERATING PROCEDURE Sign. submerge them in water to dissolve & after dissolution. take out the liquid or solution into a bucket & put it into the ditch.. 6. Glass containers & seals are kept separately for sale as a waste. 6.A.………. 5) PROCEDURE : 1) To lay down a Procedure for Disposal of Expired Finished Goods.2 Cartons or shipper or poly bags in which the finished materials were kept are separated before disposal of finished goods and disposed off separately. Ltd.………………. break the seal of bottles.… Sign. dump the slurry or solution into a ditch.1 All the finished goods are carried to the disposal area in the final packed form. Production Chemist Production Manager Q.3 The label of the labeled bottle is removed before disposal. Take out the inner carton from the shipper & finally take out the Tablets/ Capsules/ Oral Liquid/ Dry Syrup & Ointment from the inner cartons. In case of Oral Liquid.: PRODUCTION SOP NO. Head.…… Sign. 6. HSIIDC. Ltd.: SPD/05 Effective Date: 15-07-2007 Revision No. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……………. Shippers & inner cartons are burnt separately during packing material disposal.A. 5.. A.1 Civil Maintenance 5..2 Electrical Maintenance 5. 5) PROCEDURE : 5. Ltd. Manager Director .2.1 Repairs of walls and floors with plastering work.) STANDARD OPERATING PROCEDURE Sign.3 Aluminum or glass work required for doors and windows. 5. washing. Production Chemist Production Manager Q. 5.2.SARTHAK BIOTECH Pvt.…………………. 5. 5.A.1.2.2. Sector-3. Ltd.2. 5.1.2.: PRODUCTION SOP NO. 3) ACCOUNTABILITY : Production Manager/Q.…………… Sign.2 Parts on walls and other places where ever required.4 External roads linked with the Production premises.1.………. 5. 1) PURPOSE : To lay down a Procedure for Building Maintenance.1 The factory maintenance is an important part of maintaining facilities to work smoothly and hygienically and periodically maintained by repairing. Karnal. moping etc.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 CIVIL MAINTENANCE: This includes the following parts of maintenance in a building. 198-A..1. Sign. painting. TITLE: SOP FOR BUILDING MAINTENANCE Page : 02-02 Deptt.1. 5.2. 2) RESPONSIBILITY : Q/C Manager. 5.2 MAINTENANCE REQUIRED : The following categories of the maintenance are generally required in a Pharmaceutical formulation plant.……….… Sign.: SPD/05 Effective Date: 15-07-2007 Revision No. HSIIDC.3 Utilities Maintenance The above categories are further classified as under to decentralize the work according to need.2.2.. KARNAL-132 001 (HR. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.5 Insects/ Rodents protective mesh where ever provided.……. 2.…….………………….…………. sinks.2. 6. 5.3 Maintenance of air cooling system.3. Ltd.1 All major repairs of production premises: Once in 6 months.2..2 Tube lights.SARTHAK BIOTECH Pvt.2. 5.2. 198-A. Sign.2 All electrical maintenance work to be done by an expert under the supervision of Company’s Electrical Engineer. Air Conditioners.2. Production Chemist Production Manager Q.3 For Doors and glass work: Once in 2 months.2.2.3 General wiring of Production premises and electrical points. KARNAL-132 001 (HR.2.6 Lawns and plantation maintenance.2.: PRODUCTION SOP NO.. TITLE: SOP FOR DISPOSAL OF EXCESS / REJECTED Page : 01-01 PACKING MATERIAL Deptt.2. MAINTENANCE PROCEDURE: 7. pipes. 5. 7.2.2. 5.2 Maintenance of drainage system. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 The maintenance carried out when the production is not going on.2.5 For external roads: Once in a year.……….3.3.4 Records and log for all such repairs are maintained. Sign.A.3 UTILITIES MAINTENANCE: 1) 5. 6.…………… Sign. HSIIDC. Fans.) STANDARD OPERATING PROCEDURE Sign. Manager Director . 5.4 Maintenance of effluent treatment plant.2. 6. 5. 7.4 For wire mesh: Once in 6 months. 5. FREQUENCY 6. Once in a year for the complete plant & factory.3. 7.2. Insect repeller.1 Cleaning and maintenance of water distribution system. 5.5 Major electrical panels.4 Electrical water purification system where ever applicable. 5.1 Exhaust fans.3.2. taps.5 Generator system and transformer.2. 2) 6.3. 5.2.2 Paints: Once in 6 months in those areas where repair has been done. Sector-3. Air curtain.: SPD/06 Effective Date: 15-07-2007 Revision No. ELECTRICAL MAINTENANCE: 5.3 All repairs are carried out on request of the concerned Department Head in writing and approval by the above referred authorized persons. … Sign.……….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.M. 1) PURPOSE : To lay down a Procedure for Disposal of Excess / Rejected Packing Material..……….………………….……………. Sector-3..1 After completion of packing operation of one batch product.: SPD/07 Effective Date: 15-07-2007 Revision No.… Sign.SARTHAK BIOTECH Pvt. sorted out and good / without printed packing materials is counted and tied.: PRODUCTION SOP NO.5 Details of all returned materials and rejected materials are recorded in packing material reconciliation sheet included in Batch Production Record. 5) PROCEDURE : 5.A. TITLE: SOP FOR ENTRY/EXIT OF VISITORS IN Page : 01-01 MANUFACTURING AREA Deptt.2 Excess P. Q/C Manager. the packing line is checked for excess packing materials. Sign.. Production Chemist Production Manager Q. Ltd. 198-A. 5.. Manager Director . 5.……. Karnal. 5. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.) STANDARD OPERATING PROCEDURE Sign.……….4 All coded unit cartons/labels are transferred to scrap yard and shredded into pieces before disposing off.3 All good material are returned to packing material store through material return note. Ltd.A. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. KARNAL-132 001 (HR. 5. HSIIDC. SARTHAK BIOTECH Pvt. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.……………………. They cross the barrier before entering manufacturing area.………. cap & mask.) STANDARD OPERATING PROCEDURE Sign.: PRODUCTION SOP NO.: SPD/08 Effective Date: 15-07-2007 Revision No. Karnal.4 Before leaving the manufacturing area visitor remove the shoe cover.……. TITLE: SOP FOR ENTRY INTO PRODUCTION AREA Page : 01-01 Deptt. 5. After which they are dip the footwear’s in to the disinfecting solution soaked mat and then into the main working area. lab coat. cap & mask and the concerned officer send them for washing. Production Chemist Production Manager Q. 5. Manager Director . HSIIDC. Sector-3.A. Q/C Manager.A.. Ltd.1 Entry of visitor to these Areas is restricted as much as possible. Sign. 5. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.… Sign. Entry of Visitors: - 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.…………………. Sign.. 1) PURPOSE : To lay down a Procedure for Entry / Exit of Visitors in Manufacturing Area.2 Entry of visitors is given a clean lab coat.. 198-A.…………. KARNAL-132 001 (HR. Ltd.3 Then visitors & accompanying authorized person put ‘shoe cover’ on his street shoes or wear clean laboratory sleepers. 4 Outside visitors when taken for a round in the operational areas should wear aprons. HSIIDC. chew tobacco.……. head covers.. Sign.…………… Sign.3 Workman wears head cover.SARTHAK BIOTECH Pvt. 5. pan or betel nuts while working.: Prepared by: Checked By: Page : 01-01 Deptt. Before entering into any area the following norms are followed: - 5.A.) STANDARD OPERATING PROCEDURE Sign.2 Wear clean factory uniform. hair. Sector-3.. gloves..…………………. 198-A. facemask in such a way that the whole head.10 Use of cosmetics and perfumes are avoided as far as possible. Karnal.7 Do not eat.… Sign.8 Smoking is strictly prohibited in the production areas/ office premises. KARNAL-132 001 (HR. 1) PURPOSE : To lay down a Procedure for Entry into Production Area.: PRODUCTION Review Date: 14-07-2009 Approved By . Ltd. 5.6 No food or drink is carried in the production areas. masks and foot-covers where necessary. 5. 2) RESPONSIBILITY : Q/C Manager. 5. 5. 5.9 Nails are trimmed frequently.………. 5. moustaches and beards are covered so that particles on the hair do not contaminate the working areas.5 Before changing into factory uniforms. 5.: SPD/09 Effective Date: 15-07-2007 Revision No. TITLE: SOP FOR SAFETY PRACTICES SOP NO. head-covers and foot-covers as per the requirement.………. Ltd. 5.1 Wash and dry their hands. 3) ACCOUNTABILITY : Production Manager/Q. items of jewellary is removed and kept in the lockers provided. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 1 Hand gloves and safety shoes are used in the manufacturing area. 2) RESPONSIBILITY : Q/C Manager. Karnal..… Director Sign.: SPD/10 Effective Date: 15-07-2007 Revision No.……………………….. Production Chemist Production Manager Q. Enough.… Sign.. Sign. Production Chemist Production Manager Q. Ltd. TITLE: SOP FOR LOG BOOK SYSTEM Page : 01-02 Deptt.A. In case of hot work. KARNAL-132 001 (HR. Manager Director . Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.SARTHAK BIOTECH Pvt. Sector-3.…….………. there is a system to issue welding and fire permit (spark generating maintenance activity).: PRODUCTION SOP NO. 198-A. 5. 1) PURPOSE : To lay down a Procedure for Safety Practices.A. Manager Sign. Ltd. HSIIDC. etc. gloves.3 All safety precautions are adopted according to the needs.A.……….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5) PROCEDURE : 5. 5.…………………….2 Lighting and electrical fittings are flame proof. are available and used when required. 3) ACCOUNTABILITY : Production Manager/Q.) STANDARD OPERATING PROCEDURE Asstt. : SPD/10 Effective Date: 15-07-2007 Revision No. Sector-3.2 Equipment: a) Name of Equipment.A. Ltd. 198-A. Manager Director and . the log book should contain the following details: 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. FORMAT: Log-book is maintained depending upon the user department.A.) STANDARD OPERATING PROCEDURE Sign. 1) PURPOSE : To lay down a Procedure for Log Book System. Sign. 3) ACCOUNTABILITY : Production Manager/Q.. Karnal.………. No.………. c) Product & its batch number.1 5. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. HSIIDC. c) Date of Analysis d) Analysis time e) number Product analyzed & its batch f) A.… Sign. KARNAL-132 001 (HR.SARTHAK BIOTECH Pvt. d) Remarks. 2) RESPONSIBILITY : Q/C Manager. if any e) Signature of chemist and Signature of the person checking.: PRODUCTION SOP NO.… Sign. Ltd.. Lab Instrument: a) Instrument Name b) Sr. Production Chemist Production Manager Q. g) Remarks of Analysis if any h) Signature Signature of the person checking the analysis report.…………………….…….. No. b) Code No. TITLE: SOP FOR LOG BOOK SYSTEM of analyst Page : 02-02 Deptt.R.………………………. analysis data and calculation details. Calibration Log Books: a) Instrument Name b) Range c) Accuracy d) The standard used e) Calibration Frequency f) Model No. Chemist / Analyst’s Log Book: a) Date of analysis b) Name of the test.… Sign. work order should be generated by the Analyst / Chemist responsible for calibration of that instrument and maintenance details to be entered in instrument log book / chemist log book.…….……….: SPD/11 Effective Date: 15-07-2007 Revision No. c) Product analyzed & its batch number d) Signature of analyst and Signature of the person checking the analysis..……………………. g) Signature of person calibrating the equipment / instrument and Signature of the person reviewing the calibration report. Ltd.………………………. Sector-3.… 5.4 Sign. 198-A.  Equipment / Instrument Name  Service required data  Data repaired  Nature of repair work carried out in detail  Re-calibration data  Signature of chemist and date TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO.3 5.SARTHAK BIOTECH Pvt.………..: Prepared by: Checked By: Page : 01-03 Deptt.) STANDARD OPERATING PROCEDURE Sign. Note: If any instrument is malfunctioning or requires non-routine maintenance. HSIIDC. KARNAL-132 001 (HR. Sign.: PRODUCTION Review Date: 14-07-2009 Approved By . 1 Record the temperature & humidity in the environment monitoring chart. 5. Powder. Ltd.3 The limit is specified below: Area Temperature Humidity Mixing Granulation & Drying 28-29O C 70% Max.: PRODUCTION Review Date: 14-07-2009 Approved By .……….……….: SPD/11 Effective Date: 15-07-2007 Revision No. HSIIDC.. 3) ACCOUNTABILITY : Production Manager/Q.… Director Sign.……. 2) RESPONSIBILITY : Q/C Manager. Blending. 198-A. KARNAL-132 001 (HR. Tablets 23-27O C 40-45% Film Coating 25-27O C 50-55% Corridors 25-27O C 70% Max TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO. Ltd.A.) STANDARD OPERATING PROCEDURE Asstt.A.: Prepared by: Checked By: Page : 02-03 Deptt. Sector-3. Sign. Dry Syrup 23-25O C 40-45% Beta-Lactum Capsules.………………………. 5..2 Regulate the A/C of Dehumidifier if the temperature of a particular area is the out of the prescribed limit.… Sign. Production Chemist Production Manager Q.……………………. Manager Sign.SARTHAK BIOTECH Pvt. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.. Compression 25-27O C 40-45% Capsulation. Karnal. 5) PROCEDURE : 5. 1) PURPOSE : To lay down a Procedure for Environment Monitoring. … Sign. Sector-3. Sign. HSIIDC.SARTHAK BIOTECH Pvt. Ltd.A. & Bottle Washing 28-29O C 70% Max Ointment & Lotions 25-27O C 50-55% Laboratory TITLE: SOP FOR ENVIRONMENT MONITORING SOP NO.: Prepared by: Checked By: Page : 03-03 Deptt. 198-A.: PRODUCTION Review Date: 14-07-2009 Approved By ..……………………. KARNAL-132 001 (HR.…….: SPD/11 Effective Date: 15-07-2007 Revision No..………………………. Production Chemist Production Manager Q.) STANDARD OPERATING PROCEDURE Asstt.………. Manager Sign.………. Store area for • Beta Lactum 25-27O C 50% Max • Capsules & Sensitive Materials 25-27O C 50% Max • Other products 30O C 70% Max Instrument room & Microbiology room 25-27O C 50% Max Chemical Laboratory 28-30O C 70% Max Quarantine & Control Sample Room 25-27O C 50% Max Liquid Mfg.… (a) (b) Director Sign. ……………………. Sign.A.……….……. Date Area Director Sign. Record the result in the following format Time Limit Observation Remarks TITLE: SOP FOR REMOVAL OF SCRAP FROM PRODUCTION Page : 01-01 AREA Deptt.………………………. Sector-3.… 1. HSIIDC.A. KARNAL-132 001 (HR. 198-A. Manager Director .. Production Chemist Production Manager Q.……….: PRODUCTION SOP NO. Ltd.) STANDARD OPERATING PROCEDURE Asstt. Manager Sign.: SPD/12 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q..SARTHAK BIOTECH Pvt.… Sign. ……………………. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Manager Director .………..A.… Sign. TITLE: SOP FOR DISPOSAL OF EMPTY CONTAINERS Page : 01-01 Deptt.1 All scraps must be checked by House keeping Supervisor to ensure that no printed packing material container or machine parts reach at the backyard.1 All the scraps are collected in a polythene lined dust bin.… Sign.……. Karnal. Ltd.2 All scarp filled polythene bags in dustbin are taken to scrap dumping area.………. 198-A. Sign. HSIIDC.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR. Q/C Manager. 1) PURPOSE : To lay down a Procedure for Removal of Scrap form Production Area. 5) PROCEDURE : 5. 6) PRECAUTIONS: 6.. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5..: PRODUCTION SOP NO.……………………….) STANDARD OPERATING PROCEDURE Sign.A.: SPD/13 Effective Date: 15-07-2007 Revision No. Ltd. METALLIC CONTAINERS 5.4 Do not use empty containers for storage of any other material.1. 5. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Q/C Manager.) STANDARD OPERATING PROCEDURE Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Manager Director . HSIIDC.3 Cross mark on label of the corrugated box with black marking pan..……………………. 5.1 Ensure that the boxes/ containers are empty.… Sign.1.5 Destroy the containers containing hazardous / corrosive material in presence of warehouse supervisor...………………………. 5.3. Sign.A.A.2 Transfer the containers to scrap yard.1 The glass scarp is sorted out in the Scarp Yard. 5.3 Transfer them to scrap yard.3.……….… Sign.2.: PRODUCTION SOP NO.3. KARNAL-132 001 (HR. 5) PROCEDURE : 5. 5.1. CORRUGATED BOXES 5.2 Fold the boxes.2 5.2 Containers are property checked for any left out material.3 To lay down a Procedure for Disposal of Empty Containers.SARTHAK BIOTECH Pvt. 198-A. 5.2. Production Chemist Production Manager Q. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.…….1 5. GLASS CONTAINERS 5. Sector-3. stuck and tie them.3.3.………. 5. Ltd. Karnal. Ltd. TITLE: SOP FOR CLEANING OF GENERAL DRESSES Page : 01-02 Deptt.: SPD/14 Effective Date: 15-07-2007 Revision No.1 Wash all the containers with sufficient quantity of tap water. he is instructed to wash colored and white dresses separately to avoid coloration of the white dresses. All the dresses are cleaned at a single place under the supervision of the above-specified competent personnel.……….: SPD/14 Effective Date: 15-07-2007 Revision No. Sector-3.A. 5. 198-A..… : : Sign. Q/C Manager. prior to washing. HSIIDC.. 3) ACCOUNTABILITY : Production Manager/Q. Manager Director .………. 6..2 The dresses are first observed for any oil spot or other chemicals to be removed with solvent namely IPA / Ethanol.… Sign. 6. 1) 2) PURPOSE RESPONSIBILITY To lay down a Procedure for Cleaning of General Dresses. 1) CLEANING PROCEDURE : 6. Sign. Ltd.……. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Ltd.1 The collected dresses are further categorized as per their color and utilization and properly recorded in the log book available with the house keeping department.……………………….A. 5.: PRODUCTION SOP NO.SARTHAK BIOTECH Pvt. Karnal.) STANDARD OPERATING PROCEDURE Sign. KARNAL-132 001 (HR. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.2 All the unclean dresses are then segregated as per their color and use and entered in the log book prior to given for washing.1 The unclean dresses are washed by the washerman. TITLE: SOP FOR CLEANING OF GENERAL DRESSES Page : 02-02 Deptt.3 The above treated dresses are then dipped in a soap solution at a temperature between 40 to 45OC and rotated for 30 to 35 minutes.……………………. 6. HSIIDC. 6.5 Drying of the washed dresses are carried either by centrifugal method of by drying in a current of warm air..… Sign. TITLE: SOP FOR CLEANING AND SANITATION OF Page : 01-03 GENERAL AREA PRODUCTION BLOCK Deptt. 6.SARTHAK BIOTECH Pvt.… Sign.…….……….6 After complete drying of the dresses it goes under ironing. 6.) STANDARD OPERATING PROCEDURE Sign. Manager Director .………………………. Production Chemist Production Manager Q. 198-A.: PRODUCTION SOP NO.9 The cleaned dresses are then segregated as per their colour and requirements and kept in the appropriate cupboard making entry in the logbook. 6. Drying in direct sunlight is strictly avoided.: SPD/15 Effective Date: 15-07-2007 Revision No.……………………. Sector-3.. Ltd.10 The above cycle is continuously monitored and dresses are issued to each department by Signing in the logbook.11 The change in the above process is validated by the concerned Department / Personnel only. 6.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.4 The above treated dresses are then squeezed and dipped in a drum of fresh water and again rotated for 30 minutes and with another change of fresh water these are placed for spinning stage.A. KARNAL-132 001 (HR.8 All the cleaned dresses are then received and recorded in the Logbook. 6.7 The dresses are daily cleaning as per the above procedure.………. 6. Sign. Bucket 2.2 Empty waste bins and reline with plastic bags when necessary. 6. KARNAL-132 001 (HR.7 Dispose off the used water promptly. 6.: SPD/15 Effective Date: 15-07-2007 Revision No..4 Wash interior surface of commode bowl using bowl cleaner solution with a bowl mop. Daily Schedule. 1) PURPOSE : To lay down a Procedure for Removal of Scrap form Production Area. 6.) STANDARD OPERATING PROCEDURE Sign. Bucket 1 – To squeeze out the dirty water from mop.6 Use two bucket system.…….1% Teepol solution in water and wipe dry. 6.3 Wash sink and waste pipe using 0. Ltd.……….1% Teepol solution in water then with plain water and finally with a disinfectant solution. 198-A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.A.: PRODUCTION SOP NO.SARTHAK BIOTECH Pvt.5 Damp mop all accessible are using lint free or rubber lined handle mops initially with a 0. Q/C Manager. Manager 4) SCOPE : 5) FREQUENCY : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.1 Pick up the trace materials from floors.… Sign. Ltd.………………………. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. TITLE: SOP FOR CLEANING AND SANITATION OF Page : 02-03 GENERAL AREA PRODUCTION BLOCK Deptt.1% Teepol solution in water. Manager Director .. 6) PROCEDURE : 6.A.… Sign.To Contain clean water for rinsing the mop.8 Allow the floor to dry up. Production Chemist Production Manager Q. 6. Wash exterior surface of bowl seat using 0. Karnal.. Sector-3. 6. 6.…………………….………. Sign. HSIIDC. 6.9 Flush out the drainage channel after removing any solid debris. KARNAL-132 001 (HR. 7. 4. view panels and glasses with a spray of aerosols cleaner (Colin) and wipe dry. push plates. 6.SARTHAK BIOTECH Pvt.) STANDARD OPERATING PROCEDURE Sign.11 Wash hands before carrying out any other activities. floors and walls of change rooms..10 Wipe the surrounding area with a mop soaked in disinfectant solution.………. 6. Ltd.13 Mop up any spillages as soon as it occurs.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Damp wipe all surfaces with 0.: PRODUCTION SOP NO. stairways with an approved disinfectant solution.15 Fill the daily cleaning and sanitation record and get it Signed.………………………. 6. Sector-3. 3.1% Teepol solution in water. 8.: SPD/15 Effective Date: 15-07-2007 Revision No.1% Teepol solutions in water after moving out any movable equipment such as container.…….1% Teepol solution in water.………. TITLE: SOP FOR CLEANING AND SANITATION OF Page : 03-03 GENERAL AREA PRODUCTION BLOCK Deptt. Dedust all the shelves.14 Carryout the cleaning operation as and when necessary to ensure the aera as clean and hygienic. Sign.A. Hose down the passages with plenty of water. 9. the storage and weighting area using a sponge. Wipe down the handrails. 6. Manager Director . 198-A. 6.. Dedust exhaust fan. 6. light fixer with sponge or cloth. Weekly Schedule: 1. HSIIDC. Production Chemist Production Manager Q. Damp wipe the accessible parts of intercom with sponge or cloth. Damp wipe all other fixer with a sponge or cloth using 0. 6. Flush out the water.…………………….… Sign. 5.… Sign. Clean the wall using sponge impregnated with 0. Damp wipe the doors. 2. weighing balance.12 Rotate the disinfectant to be used on daily basis and record the same in daily cleaning. TITLE: SOP FOR CALIBRATION AND OPERATION OF WEIGHING BALANCE SOP No. 3) Clean wipe the light diffuser and U.P. Light tube with a wet cloth. Sector-3. 198-A.……….… Sign.) STANDARD OPERATING PROCEDURE Sign.A..………………………. KARNAL-132 001 (HR.: Prepared by: Checked By: Page : 01-02 Deptt.SARTHAK BIOTECH Pvt. Monthly Schedule 1) Wash waste bin with a disinfectant solution. HSIIDC. 4) Clean wipe the light switches with I. 2) Apply the floor finish on clean and dry floor and rub it to polish.: SPD/16 Effective Date: 15-07-2007 Revision No.V. Sign.: PRODUCTION Review Date: 14-07-2009 Approved By .…………………….. Ltd.…….… Sign.………. 1 Switch off the electric supply to the balance.A. 5 kg. Inform the Production Executive and call the Service Engineer.25% max.… Sign.……….A. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.25% max. Ltd. . Karnal. 6. 6. +0.1% Teepol solution followed by clean water.1 % max..……………………. in case of an electric balance.8 Do not use the balance if the error is not rectified.. 5) PROCEDURE : 6) CALIBRATION : 6.7 If the error is more than acceptable limits. Ltd. HSIIDC. Sign. 1) PURPOSE : To lay down a Procedure for Calibration and Operation of Weighing Balance. +0. 6. Record the rading in respect calibration record.SARTHAK BIOTECH Pvt.00 gm 400 gm 5 kg.) STANDARD OPERATING PROCEDURE Asstt. Place standard weight s one by one on the platform/ pan.5 In case of electronic balance switch “ON” the balance. 6. 6. adjust the balance whether electronic or mechanical to zero. These records are available at weighing station.2 Clean the pan/ platform of the balance with a brush. as given in this SOP. Director Sign. Sector-3. If required cleaning is done with clean cloth dipped in 0.4 Select the standard weights for various weighing balance based upon the capacity of balance to be calibrated.……. 50 kg.. Balance Capacity 200 gm 6 kg 60 kg 100 kg Standard Weight 1. Acceptable Limit +0. +0. 6.3 Check the level of balance and ensure that the balance is properly leveled.…………. the error is rectified before the balance is to be used. Manager Sign. 198-A. KARNAL-132 001 (HR. Production Chemist Production Manager Q.6 Check that the observed weights are within the limits. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Q/C Manager. Standard Weight 10 gm 5 kg.………………………. 6. 10 kg.25% max. 2 Clean the pan of the balance with brush. KARNAL-132 001 (HR. Sector-3. water and wipe dry with clean cloth. Ltd.1% followed by D.. 6.: SPD/16 Effective Date: 15-07-2007 Revision No.R. 7. 7. No.M.4 Keep pallets and stainless steel containers near the balance. Manager Director Sign. Check the weights against requisition slip and batch production record.………….6 In case of electronic balance. Selection of standard weights for interpretation of data is given below :- OPERATION:7.SARTHAK BIOTECH Pvt.………. tare weight and net weight of material..: Review Date: 14-07-2009 Checked By: Approved By Prepared by: Production Manager Asstt. if any error is observed.0 Sign. switch “OFF” electric supply to the balance. 7.……………………. gross weight.9 7. .7 Balance set to zero.3 Level the balance property.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CALIBRATION AND OPERATION OF Page : 02-02 WEIGHING BALANCE Deptt. 7.………………………. switch “ON” the power supply. Checks tally the name of material. 7.9 Material tags are tally with the details on Batch Production Record. A. 7. Sign. In case of mechanical balance check ZERO reading. Teepol solution 0. press the “ON” switch on the digital control and wait till it indicates ZERO.1 In case of electronic balance. 7. Production Chemist Q.: PRODUCTION SOP No..5 In case of electronic balance. If required. 7.8 Place the material on the balance platform / pan by one and check.A. 198-A.……. HSIIDC.… Sign. 5) PROCEDURE : 5.: SPD/17 Effective Date: 15-07-2007 Revision No.1.……………………. .1. and 5. 5.: PRODUCTION SOP No. Ltd.1.1 Loosen the bolt of the capsule filling machine.2 Dismantle all the supporting plates & lock plates from the machine dip in water. Manager Director Sign. Q/C Department.A.……………………….3 Remove the powder from the machine by the Nylon brush.1) To lay down a Procedure for Cleaning and Operation of Manual Capsule Filling Machine.5 Rinse with DM water. First clean with 0.……….1. Sign. HSIIDC. Ltd.1.……. Q/C Manager.1. Transfer all parts to washing area.…………..… Sign.7 Send a wash water sample for analysis of previous product to Q/A..6 Dry the machine.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 198-A..) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL Page : 01-02 CAPSULE FILLING MACHINE Deptt.4 Wash the machine with raw water.1. CLEANING : 5. 5. 5. Karnal. Production Chemist Production Manager Q. KARNAL-132 001 (HR. 5. Sign.SARTHAK BIOTECH Pvt.1% Teepol solution or equivalent soap solution by moping with non woven cloth. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Sector-3. 5. KARNAL-132 001 (HR. “READY FOR USE”. 5. Manager Director Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.5 Press the top plate on filled magazine.: SPD/17 Effective Date: 15-07-2007 Revision No.: PRODUCTION SOP No.7 Loosen the lock bolt.1.9 Record the machine cleaning / operation in record. HSIIDC. Format.. 5. 5.1. till the batch is finished.. 5.…………. reassemble the capsule machine for filling of next batch (Product).8 Continue the same process. Production Chemist Production Manager Q. Ltd.1.2) Sign.……………………….……….3 Fix the Guide Plate on the machine. and lock the plate by pressing with handle. 5.SARTHAK BIOTECH Pvt.1. spray the powder by a plastic made spreader. Put the powder on the capsule magazine.6 Load the caps part of the capsules. 198-A.1.1. OPERATION:5. 5. Sector-3. of powder to be filled for 300 capsules.4 Weigh qty. . 5.1 After receiving the QC report fix a label.1.1.…….) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF MANUAL Page : 02-02 CAPSULE FILLING MACHINE Deptt.1. 5.2 After getting QC report. Sign.A.… Sign. remove the filled capsules. 5.……………………. 7 Rinse with raw water.1%) or eq.3 Remove the blister forming roller. 5.SARTHAK BIOTECH Pvt. soap solution by nylon cloth / foam.sealing roller etc. chute. hopper. KARNAL-132 001 (HR. 5. CLEANING 5.……. Sign. raw water supply line.8 Close the valve of compressed air. channel. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.…………. HSIIDC. 198-A.………………………. Production Chemist Production Manager Q. soap solution by nylon cloth / foam.1%) or eq. and finally with DM Water. Ltd.A.……….9 Proper oiling and greasing in the machine are necessary before installation of machine..: PRODUCTION SOP No. 5. and then rinse with DM Water. 5. Sign. .. plate .6 Clean the conveyor belt with the Teepol solution (0.… Sign.2 Clean the blister packing machine with Teepol solution (0. 5. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. ink device. Manager Director Sign. reassemble the machine. Karnal.4 Clean them with Teepol solution (0. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of Blister Packing Machine.. 5. Sector-3. Ltd.10 After drying.1%) or eq. 5.5 Rinse with raw water. 5. Q/C Manager.: SPD/18 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF BLISTER Page : 01-02 PACKING MACHINE Deptt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. soap solution by nylon cloth / foam.A. 5.1 Switch OFF the mains.……………………. 6.A.……………………. 198-A. and fix the stores.: SPD/18 Effective Date: 15-07-2007 Revision No. Manager Director Sign.………. 6. Ltd. fix the blister/ PVC roll and printed aluminum foil of the required product. KARNAL-132 001 (HR.. HSIIDC. 6. 6.… Sign. forming rolls.7 Load the hopper with tablets/ capsules for commercial packing. chute.8 Check the sealing by Leak Test method.4 Start the temperature heating element and roller forming switch.: PRODUCTION SOP No..………….6 Now start the machine to check the forming cavity and sealing of blister strip. 160OC.…….………………………. Production Chemist Production Manager Q.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-02 BLISTER PACKING MACHINE Deptt. . Sector-3. 6.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 6. 6. OPERATION : 6.1 Before the starting of the machine check the sealing roller.2 Open the valve of compressed air and raw water. Sign. hopper etc.3 Fill the ink pot with the ink. guide track.5 When temperature reaches at approx.SARTHAK BIOTECH Pvt. 6. Sign. 5. 5.4 Clean the cone blender with 0. Karnal.: SPD/19 Effective Date: 15-07-2007 Revision No. 5. Ltd. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-02 .2 Loosen the bolt/ clamp of the cone blender.: PRODUCTION SOP No. Manager Director Sign. 5. Ltd. Sign. finally clean with DM Water.6 Mop the external parts of the cone blender/ frames by the non woven cloth.05%). 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.3 Remove the gasket and top of the mouth from the cone blender..1 Switch OFF the mains of Cone Blender.7 After complete cleaning of cone blender send wash water sample for analysis. Production Chemist Production Manager Q.… Sign.5 Rinse with raw water..1% Teepol solution by moping with non woven cloth. 198-A.SARTHAK BIOTECH Pvt. Sector-3. 5.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.…………. CLEANING: 5. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of Double Cone Blender. HSIIDC. 5.………. KARNAL-132 001 (HR. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-02 DOUBLE CONE BLENDER Deptt. Q/C Manager.…………………….……………………….……. dip in a soap or Teepol solution (0. Sign.A.. 6. keep distance at least 3 ft. HSIIDC.……..1 After getting the wash water report.A. Sign.6 Start the machine for mixing CAUTION: – Before starting of the machine.: SPD/19 Effective Date: 15-07-2007 Revision No. from the machine to avoid the accident.3 Add the batch (Powder) for mixing.4 Close the top lid. 6. Ltd. 6.………. OPERATION:6.. Sector-3. TITLE: SOP FOR CLEANING AND OPERATION OF DRY Page : 01-02 . KARNAL-132 001 (HR. Manager Director Sign.… Sign.2 Switch “ON” the mains. 6.………….………………………. fix a label “MACHINE IS READY FOR USE”.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: PRODUCTION SOP No. Production Chemist Production Manager Q. 6.SARTHAK BIOTECH Pvt. 6.5 Tight the bolts/ clamps. Sign. fitted with gasket.) STANDARD OPERATING PROCEDURE DOUBLE CONE BLENDER Deptt.……………………. 198-A. 5) PROCEDURE : 5.A. Ltd.) STANDARD OPERATING PROCEDURE FILLING MACHINE Deptt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1. department. KARNAL-132 001 (HR.…….………………………. Sign.6 Mop the dismantled parts by non woven cloth.2 Loosen the bolt.SARTHAK BIOTECH Pvt.A.1.1. Production Chemist Production Manager Q.9 Finally rinse with DM Water and send a sample of wash water to the Q. 5.A. Manager Director Sign.3 Dismantle the auger & nozzle.……….: SPD/20 Effective Date: 15-07-2007 Revision No. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.1) To lay down a Procedure for Cleaning and Operation of Dry Filling Macnine.4 Loose the weight variation adjustment lock.1.1. 5.1 Switch OFF the mains. Ltd. Sign. 198-A. 5. 5. Sector-3.8 Clean the external machine parts and body with DM Water by wet moping and dry the machine. 5.…………. .… Sign.5 Dip all the dismantled parts in 0.1. 5.. Karnal. CLEANING:5. remove the lock of hopper of dry syrup filing machine.7 Rinse with raw water till frothing is removed. Q/C Manager..1% Teepol solution.1.1. 5. 5.: PRODUCTION SOP No.……………………. HSIIDC.1.. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. 5. 5.2 Reassemble all the dismantled parts of the machine i. OPERATION 5.…………………….4 Start the machine and check the weight of fixed quantity of each bottle.. 5. weight wheel. auger. 5. switch “ON” the mains.: PRODUCTION SOP No.… Sign. Sector-3.2. HSIIDC.5 Check the adjusted weight for at least 10 bottles of dry syrup. hopper etc.2) Sign.8 Record pertaining to cleaning.A. Sign. Production Chemist Production Manager Q. operation and weight variation is recorded in format.………………………. 5. Manager Director Sign.2. 198-A.2.………. KARNAL-132 001 (HR.2.6 Now start the production till the batch is finished.2..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. department fix a label “MACHINE IS READY FOR USE”. 5.…….2.A. 5.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING AND OPERATION OF DRY Page : 02-02 FILLING MACHINE Deptt. 5.2.2. Ltd.e.: SPD/20 Effective Date: 15-07-2007 Revision No.3 Add the powder/ granules of next batch. TITLE: SOP FOR CLEANING AND OPERATION OF ROPP Page : 01-01 .7 Checking of weight variation of filled dry syrup bottles is done after every 30 minutes.1 After getting the result form Q.………….SARTHAK BIOTECH Pvt. ……………………….) STANDARD OPERATING PROCEDURE CAP BOTTLE SEALING MACHINE Deptt.A.………. 5.1 Switch OFF the mains. 5. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.…….A.. Finally clean the machine with dry cloth.SARTHAK BIOTECH Pvt. 5.2. 5.2.1 Adjust the height of bottle with ROPP cap dry inching method.6 5. Manager Director Sign. Production Chemist Production Manager Q..… Sign. KARNAL-132 001 (HR. Karnal.………….4 Now start the production till the batch is finished. 5.1. 5.1. Sign.. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: PRODUCTION SOP No. Ltd.O.1.1%) or eq. HSIIDC. Sector-3.P. Ltd.2. 5) PROCEDURE : 5.2.1 CLEANING:5.3 Adjust the guide of the bottle pressing plate / lifting plate with sealing die. Apply the grease / Lubricant oil to the axle of the footrest and lever of sealing die guide.: SPD/21 Effective Date: 15-07-2007 Revision No.2 To lay down a Procedure for Cleaning and Operation of R.4 5. OPERATION:5.2 Clean he machine with Teepol solution (0. soap solution. Clean with the dry cloth dipped in diesel to avoid the rust from environment.1. Cap Bottle Sealing Machine.1.2 Check the sealing of 10 dry syrup bottles for good quality of sealing.5 Clean the footrest with dry cloth by moping. TITLE: SOP FOR DECARTONING OF CONTAINERS AND Page : 01-01 . Reassemble the die.3 Dismantle the sealing die.……………………. 5.5 Record the total cleaning and operation in record book format.P.1. 198-A.2. Q/C Manager. 5. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.………….. No shipping box is slowed in clean area. Sector-3.. Sign. Ltd.) STANDARD OPERATING PROCEDURE CLOSURES Deptt.SARTHAK BIOTECH Pvt..A.………………………. 5.1 All filling materials must be requested from the warehouse well in advance. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. TITLE: SOP FOR CONTROLLING MICROBIAL Page : 01-01 .1.1. These are supplied in their shipping boxes or shrink wrapped trays.1 To lay down a Procedure for Decartoning of Containers and Clousres. Ltd. Manager Director Sign.A. KARNAL-132 001 (HR. HSIIDC.……………………. Karnal. 5) PROCEDURE : 5.1.…….4 All wastage is deposited in the dustbins provided.1.: PRODUCTION SOP No. General Rules : 5.3 Tearing off paper in the clean area is not permitted.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Q/C Manager. 198-A.… Sign.………. 5. Production Chemist Production Manager Q.2 All excess material supplied which is not used is returned to warehouse. No unnecessary material is allowed to accumulate in clean area. 5. Sign.: SPD/22 Effective Date: 15-07-2007 Revision No. . Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.  If manufacturing equipment is stored for more than three days it must be resanitize before Use.…….1% hot Teepol solution  Now finally rinse with DM water . HSIIDC. Ltd. Filling equipment clean up and sanitization: Dissemble all parts that come in contact with product. 198-A. scrapper with nylon scrubber to remover trace of the pervious product.  Scrub the vessel.………….SARTHAK BIOTECH Pvt.1% Teepol solution  Rinse the floor and working table with hot water. Sign. Karnal.  Disassemble the other equipment which comes in to content with product and clean with hot 0.  Scrub all contact parts with 0. agitator. Controlling Microbial Contamination:.. Q/C Manager.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. KARNAL-132 001 (HR.……………………….………. Ltd. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.… Sign. Compounding room cleans up:  Moping the floor and working table with hot 0. Sign.…………………….: PRODUCTION SOP No. Manager Director Sign.: SPD/23 Effective Date: 15-07-2007 Revision No. cover.1% Teepol solution and rinse with DM water and sanitize with 70% IPA.A. Production Chemist Production Manager Q.Producing product of 100% efficacy by adopting following procedures: a) b) c) To lay down a Procedure for Controlling Microbial Contamination (Ointment Section).  Keep personnel traffic to a minimum.1% Teepol solution.) STANDARD OPERATING PROCEDURE CONTAMINATION (OINTMENT SECTION) Deptt. Compounding equipment cleans up: It is done just after completion of current batch  Clean the melting and compounding vessel with hot 0.A.. 9 Production Manager / Q. shipper carton.……….8 The packing area/ belt/ table are cleaned and mopped before starting packing of next product / batch. Sector-3.……………………….…….A. Sign. boxes. Karnal. Ltd..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.…………. Sign.A. 3) ACCOUNTABILITY : Production Manager/Q. Manager Director Sign. 198-A. are properly labeled and send to recovery quarantine.… Sign.……………………. It is send to quarantine for storage till next packing schedule.1 Packing line is cleared after every product changeover. 5.4 All intact packing materials. 5. 5. Manager jointly conduct line clearance operation.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR.2 All unpacked goods are packed in one container and properly labeled.6 The finished goods are accounted for and transferred to Finished Goods stores along with finished good transfer slip.7 The packing belt / tables are cleaned both from top and floor and waste is collected in dust bin. Manager/ Production Manager. 5.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR LINE CLEARANCE (PACKING) Page : 01-01 Deptt. 5. 5.10 Line clearance operation is recorded in prescribed format and duly signed by Q..: PRODUCTION SOP No. 5) PROCEDURE : 5.3 All rejected goods. Ltd.: SPD/24 Effective Date: 15-07-2007 Revision No. 5.A. . 1) PURPOSE : To lay down a Procedure for Line Clearance (Packing). 2) RESPONSIBILITY : Q/C Manager.. HSIIDC.A. Production Chemist Production Manager Q. 5. 5. if recoverable.5 All torn / rejected packing material and rejected goods are shifted to scrap yard in a polythene bag for disposal. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. labels are properly counted and tied and returned to packing store. 3) ACCOUNTABILITY : Production Manager/Q.6 The percentage of rejection found is to be recorded in flow sheet and register. 198-A. B. KARNAL-132 001 (HR.……………………….: PRODUCTION SOP No.… Sign.: SPD/25 Effective Date: 15-07-2007 Revision No. 5.……. Sector-3. 5) PROCEDURE : 5. D/M. 5.5 Visual inspection is done by unaided naked eye. Sign.. Ltd.9 Finally calculate the percentage of rejection of complete batch and transfer to packing department with details bearing product name.. 5.8 Rotation gap between one group to other group is two hourly. Size. 5. 5. No. 5.………….SARTHAK BIOTECH Pvt.2 Depute the visual inspection team for proper checking of fiber / glass / black white particles and any foreign matter.……………………. Sign.A.7 The visual inspection team personnel are needed maintained accordingly to ensure the proper checking of foreign matter. D/E.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR VISUAL INSPECTION Page : 01-01 Deptt.……….1 Test and release filled bottle of the product received from quarantine area to visual inspection area.A.3 Check the proper sealing of bottle.. 5. TITLE: SOP FOR BATCH CODING Page : 01-01 . HSIIDC. Ltd. 2) RESPONSIBILITY : Q/C Manager. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5. Karnal. Manager Director Sign.4 The complete visual inspection team is divided into 2 group of expert team. 1) PURPOSE : To lay down a Procedure for Visual Inspection. Production Chemist Production Manager Q. P.g.……….………….: PRODUCTION .…….O. Sign. Ltd. Manager Director Sign. KARNAL-132 001 (HR.. B1 Capsules/ Tablets B2 Dry Syrup B3 Topical Creams and Ointment. Procedure of batch coding. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q..………………………. 198-A.……………………. A. Karnal. Ltd. Name of the authorized personnel B. Production Chemist Production Manager Q. D3 3rd and 4th place are denote serial No. HSIIDC. Cap Bottle Sealing Machine. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of R. Sector-3. Q/C Manager. D2 1st and 2nd place are denote product code as per attached list e.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. TITLE: SOP FOR REPROCESSING OF RECOVERY Page : 01-01 Deptt. D1 Batch Code have minimum 3-4 digits.g. C. 02 denotes 2 nd batch of the year of that particular product. Sign.SARTHAK BIOTECH Pvt..: PRODUCTION SOP No. of batch e. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.A.A.P.… Sign. Details of the dosage forms for which batch coding requires. All the dosage forms are properly categorized with different codes explaining the details of each individual batch which is prepared and approved by the authorized personnel only.: SPD/26 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE Deptt. 3) ACCOUNTABILITY : Production Manager/Q.SARTHAK BIOTECH Pvt.……. KARNAL-132 001 (HR.6 Filtered solution is filled as a new batch and new Batch No. E/D.7 The expiry of the new batch is the expiry of the oldest recorded batch. Sign. Department – recovered solution is filtered through sterile membrane filter in a sterile filling vessel.3 Nitrogen flushing of the recovered solution is done till the batch is filled.………. Sector-3. closed container.: PRODUCTION Review Date: 14-07-2009 . Ltd.: SPD/28 Effective Date: 15-07-2007 Revision No. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. M/D.. 5) PROCEDURE : 5. 5.: Page : 01-02 Deptt. TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING) SOP No.5 After getting the approval from the Q.2 The bottle are collected and transferred in a clean area and reopened and solution is collected in a S. 5.………………………. 2) RESPONSIBILITY : Q/C Manager.1 The recoverable bottle of the different batches are collected and reported in new flow sheet with a batch no.: SPD/27 Effective Date: 15-07-2007 Revision No.S. HSIIDC.A.4 Recovered bulk solution is sent for testing to check the pH. 198-A. 5. Ltd. 5. Manager Director Sign.A. batch size and expiry date must be mentioned of the first batch of recovery.. Sign. 5.… Sign.……………………. Karnal...) STANDARD OPERATING PROCEDURE SOP No.8 Recovery details are to be recorded in the presented format of the Batch Record.…………. assay and other tests as required. is mentioned in each and every stage. Production Chemist Production Manager Q. 5. 1) PURPOSE : To lay down a Procedure for Reprocessing of Recovery.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5.A. SARTHAK BIOTECH Pvt. Sector-3..…………..A. 5. 5.… Sign. 5.…………………….………………………. Use a metal grid or screen to hold the sample submerged. whichever is higher) to be collected from the machine at the time of start up and then at an interval of 1 hours. 5) PROCEDURE : 5.5 Carefully dry the samples with tissue paper or soft cloth. 198-A.: PRODUCTION . HSIIDC. 5.A. 1) PURPOSE : To lay down a Procedure for Leak Test for Capsules / Tablets (Strip and Blister Packing).1 A sample of 4 strips (pr equivalent to 40 pockets. Manager Director Sign.2 Place the sample into a vacuum dessicator containing enough water to cover the sample with at least one inch of water (measured from the top surface of package). 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Q/C Manager.4 Slowly release the vacuum and remove the samples. Production Chemist Checked By: Production Manager Approved By Q.………. taking between 30 seconds and one minute to raise the vacuum. KARNAL-132 001 (HR. Sign. Karnal.3 Close the dessicator and slowly apply 10 inches (25 cm) of vacuum as read on a vacuum gauge. Sign.…….. Ltd. Hold under vacuum for 3 minutes. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.) STANDARD OPERATING PROCEDURE Prepared by: Asstt. TITLE: SOP FOR LEAK TEST FOR CAPSULES/TABLETS (STRIP AND BLISTER PACKING) Page : 02-02 Deptt. Present the vacuum line for 10 inches of vacuum by means of valve. Ltd. select another representative set of samples. i..A.SARTHAK BIOTECH Pvt. If no leakage is detected.8 After adjustment of the sealing machine.9 Record the results of all tests in the packing record.7 If one pocket shows evidence of leakage. and repeat the leak test. the sample size.………….……………………….……………………. the line may be restarted. and immediately notify the packing line supervisor so that corrective action may be taken. reject the sample. water. Manager Director Sign.6 Examine all pockets for evidence of leakage. stop the line.: PRODUCTION . the number of leaking samples. indicating the time tested.…….) STANDARD OPERATING PROCEDURE SOP No. adjust the machine and perform re-testing until the process is demonstrated to be under control. If leakage of any sample is still evident. HSIIDC. Ltd.: SPD/28 Effective Date: 15-07-2007 Revision No. Sign. 198-A. Sector-3. 5. 5. found. 5.. KARNAL-132 001 (HR. TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE Page : 01-03 Deptt. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.e. 5.………. Sign. the corrective action taken and the result of further testing.… Sign. M. Ltd.…………. Manager Director Sign.: SPD/29 Effective Date: 15-07-2007 Revision No.… Sign. Q/C Manager.A. Cleaning of parts:Clean the above parts by washing with 0. Dedusting external surfaces:- Use clean nylon brush and wipe with clean dry lint free duster. 198-A. 2. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. HSIIDC.1% Teepol solution and scrubbing with soft nylon brush. Sign.: PRODUCTION Review Date: 14-07-2009 .SARTHAK BIOTECH Pvt.: Page : 02-03 Deptt. Clean back and front cover and empty capsules hopper using clean dry lint free duster. Sign. Ltd. 3. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q...……. Clean loading platform with wet duster. TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE SOP No.……………………. Sector-3. Karnal. FOR PRODUCT TO PRODUCT CHANGEOVER: 1. Production Chemist Production Manager Q. To lay down a Procedure for Cleaning and Operation of Capsule Loader Machine. water.: SPD/29 Effective Date: 15-07-2007 Revision No. Rinse with jet of potable water followed by rinsing with D. (b) Empty capsule hopper.………. (c) Magazine followed by pusher plate and raceway.……………………….. Dismantling Remove:- (a) Back and front cover. KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE SOP No.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. : SPD/29 Effective Date: 15-07-2007 Revision No. 6. 4. 6. KARNAL-132 001 (HR. 5. Sign.3 Remove empty capsules from loading platform by bursh.… Sign.: Prepared by: Checked By: Page : 03-03 Deptt. HSIIDC.……………………. Production Chemist Checked By: Production Manager Approved By Q.A. Sector-3. CAUTION: In case of any abnormal sound from machine during its operation. Ltd.. 5.1 Empty out the hopper. Manager Director Sign. 198-A. PROCEDURE FOR BATCH TO BATCH CHANGEOVER:6..1 Fix the ‘cleaned’ label.SARTHAK BIOTECH Pvt.………. 6. stop the machine and report to maintenance. Drying:The cleaned parts as mentioned in step 3 are wiped and dried using clean dry lint free duster. Sign.……………………….: PRODUCTION Review Date: 14-07-2009 Approved By . 5. TITLE: SOP FOR CLEANING & OPERATION OF CAPSULE LOADER MACHINE SOP No.…………. then wipe the body by using a freshly laundered lint free duster. Assembling:Reassemble all the parts of the machine carefully checking the correctness of assembling.2 Remove back and front cover.) STANDARD OPERATING PROCEDURE Prepared by: Asstt.2 If the cleaned loader is not used within 24 hours after cleaning or there are sign of dust or powder settled on loader.4 Dry-clean the loader with clean dry lint free duster. Note: 6.……. 8. 7. Clean machine and dismantled parts as per standard cleaning procedure. DISMANTLING:9. ASSEMBLING:7.. Manager Director ..2 Load empty capsules in hopper. Ltd.4 Empty capsules hopper.5 Push loading plate inside by turning front knob in clockwise direction. 9. Sign. TITLE: SOP FOR CLEANING & OPERATION OF Page : 01-02 DEHUMIDIFIER Deptt. 7. HSIIDC. 10. 198-A.……………………….) STANDARD OPERATING PROCEDURE Asstt.: PRODUCTION SOP No.…………………….…………. Production Chemist Production Manager Q. OPERATION:8.4 Fit capsules loading plate on loading table.A.…….3 Switch on mains of machine.1 Ensure that all parts of machine are cleaned as per standard procedure.: SPD/30 Effective Date: 15-07-2007 Revision No.A.… Sign. 9. Director Sign. 7. Manager Sign. Push the green button to load capsules. KARNAL-132 001 (HR. 9. Sector-3.………. Production Chemist Production Manager Q. 8. 8.3 Front and back cover.1 Assemble clean and dry accessories in following manner.2 Remove the empty capsules hopper.1 Remove the front and back cover. 8.SARTHAK BIOTECH Pvt.3 Remove magazine followed by pusher plate and raceway.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.2 Raceway along with pusher slide and magazine 7. 8. CAUTIONS: Switch off the electrical mains of the machine. 1% Teepol solution. Manager Director . Get it cleaned by spraying hot DM Water spray and finally get it dried by blowing warm air current.……………………….… Sign. TITLE: SOP FOR CLEANING & OPERATION OF Page : 02-02 DEHUMIDIFIER Deptt. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.: PRODUCTION SOP No. 5) PROCEDURE : 5.6) The water storage SS tank is thoroughly washed and cleaned with 0. Sign. 5.01% Teepol solution and finally with DM Water. Switch off the mains Clean all surfaces of instruments by clean dry cloth. KARNAL-132 001 (HR.: SPD/30 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt.2) 5.) STANDARD OPERATING PROCEDURE Sign. Clean it again with next dry lint free cloth.. Sector-3.…….5) To lay down a Procedure for Cleaning and Operation of Dehumidifier.…………. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Q/C Manager.………. Take out the Pre-filter and wash it with 0.A. Production Chemist Production Manager Q. Dry pre-filter with the dry heat blow. Sign... HSIIDC.7) 1st ice formation takes place on the inner surface of Pre-filter. Karnal. 5. Ltd. then with wet cloth dipped in 0.4) 5.1) 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Ltd.3) 5.……………………. 198-A.A.1% Teepol solution and finally with DM Water. Production Chemist Production Manager Q.) STANDARD OPERATING PROCEDURE Sign. Sector-3.1 Ensure that all parts of machine are cleaned as per standard procedure. 6. 6. 6. Sign. TITLE: SOP FOR CLEANING & OPERATION OF STRIP Page : 01-02 PACKING MACHINE Deptt.3 Switch on mains of electricity supply after all setting of its implements.6 After getting the desired temperature and relative humidity percentage.8 Record all valuable data in record format. stop it and report to maintenance for overhauling.… Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 198-A.4 Keep it ON before one and half hours of the start of working. OPERATION:6. KARNAL-132 001 (HR. 6.……. if area is found perfect.…………………….……………………….A. 6.: SPD/31 Effective Date: 15-07-2007 Revision No.……….. production conducted scientifically. CAUTION: In case of any abnormal sound or disturbance from machine during operation.: PRODUCTION SOP No. 6. Manager Director ..………….SARTHAK BIOTECH Pvt. HSIIDC. 6.5 Check relative humidity percent of the area half on hourly. 6.2 Check the manufacturing area from the point of exposures and disturbances. Sign. Ltd.7 Temperature regulation of the working area is to be controlled by air conditioning procedure. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. KARNAL-132 001 (HR.1 Switch OFF the mains.1. Clean the conveyor belt with the Teepol solution (0.1%) or eq.A. Sign..5 5.1.1.………….4 Clean them with Teepol solution (0. soap solution by nylon brush/ brass brush. Proper oiling and greasing in the machine is necessary before installation of machine. 5.1%) or eq. ink device.: 31 Effective Date: 15-07-2007 Revision No..1.7 5.6 5. Rinse with raw water. reassemble the machine.3 Remove the strip forming roller. Q/C Manager. 5. Then Rinse with DM Water.1..… Sign. chute.5%) or eq.……………………….: PRODUCTION SOP No.SARTHAK BIOTECH Pvt.……. sealing roller etc. hopper. Sector-3.9 Rinse with raw water. Ltd. Manager Director . 5) PROCEDURE : 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. CLEANING: 5. 5. channel. plate. After drying. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Production Chemist Production Manager Q. Sign. HSIIDC.) STANDARD OPERATING PROCEDURE Sign.1.A.2 Clean the strip-packing machine with Teepol solution (0.………. Karnal.1 To lay down a Procedure for Cleaning and Operation of Strip Packing Machine.1.1. soap solution by nylon cloth / foam. soap solution by nylon cloth / foam. 5. 198-A.……………………. Ltd.8 5. and finally with DM Water. TITLE: SOP FOR CLEANING & OPERATION OF STRIP Page : 02-02 PACKING MACHINE Deptt.1. guide track. Ltd. HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.2. and fix the stereos.…………………….2.2.2. 5. Manager Director .SARTHAK BIOTECH Pvt.… Sign. Sector-3. hopper etc. forming rolls.6 Now start the machine to check the forming cavity and sealing of strip.5 When temperature reaches at approx 120OC.3 Fill ink with the inkpot.………………………. check the sealing roller.2. chute. 5. TITLE: SOP FOR CLEANING & OPERATION OF SIFTER Page : 01-02 Deptt. 5.) STANDARD OPERATING PROCEDURE Sign. Sign.A. Production Chemist Production Manager Q.2 Switch OFF the mains. 198-A. Before the starting of the machine.8 Check the sealing of strip by leak test method. 5.: SPD/32 Effective Date: 15-07-2007 Revision No.……. 5.2.……….2 OPERATION : 5.1 5.…….2. KARNAL-132 001 (HR.. 5. Sign.: PRODUCTION SOP No.7 Load the hopper with capsules/ tablets for commercial packing. fix the aluminum foil of the required product.. 5.4 Start the temperature-heating element and forming roller switch.…….2.. Sign.………. 5..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5. Manager Director . holding the sieve in place c) SS wire mesh sieve. 5.) STANDARD OPERATING PROCEDURE Sign.7 Carry out step 1 to 5 for the SS base plate with discharge outlet attached to the sifter stand. As soon as the shifting process is over. 5. Sector-3.3 Wash these articles with 0.: PRODUCTION SOP No. KARNAL-132 001 (HR.… Sign. Ltd. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of Sifter. 5.1 Remove all the residual powder adhering to the above mentioned articles with the help of a nylon brush..…………. TITLE: SOP FOR CLEANING & OPERATION OF SIFTER Page : 02-02 Deptt. Q/C Manager. Ltd.SARTHAK BIOTECH Pvt. 5. 5.2 Wash these articles with hot water. HSIIDC.…………………….5 Drain off all the water and dry all the articles. Karnal. 5. Production Chemist Production Manager Q.. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: SPD/32 Effective Date: 15-07-2007 Revision No.4 Clean these articles with running water to remove all traces of detergent. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.1% Teepol solution. dismantle the following parts: a) SS feed hopper b) SS frame.8 Assemble all the cleaned / dried articles from step 5 on the Sifter stand frame.……………………….A. Sign.A.6 Clean the exterior of the sifter stand and motor assembly with the help of a lint free wet cloth. 198-A.……. 198-A. d) Date of cleaning. e) Supervised by OPERATION: 7. 7.……. Affix a clean label giving following information: a) Name of the equipment. 7.) STANDARD OPERATING PROCEDURE Sign.………………………. KARNAL-132 001 (HR.4 Switch “ON” the machine.1 Before starting the shifting operation.8 Clean the Sifter as per SOP.… Sign. tie the polybag.: Prepared by: Checked By: Page : 01-03 Deptt. TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN STORE SOP No.…………………….. ensure that the machine is clean. CAUTION: Please clean before use. b) Name of the last product shifted..7 After the operation is over. Sign. close the lid of drum and fix identification label on it showing the Name.: SPD/33 Effective Date: 15-07-2007 Revision No. Sign. 6.………. 7. 7. Batch No. 7.…………. 7.2 Put appropriate quantity of material to be shifted on the SS mesh sieve using cleaned SS scoops. fix ‘To be cleaned’ label on the machine.6 Repeat steps 2 to 5 until the shifting process is completed. 7. HSIIDC. Ltd. c) Name of the operator who cleaned the equipment. 7.5 After the drum is filled to 80-90% capacity.SARTHAK BIOTECH Pvt.3 Tie polybags kept in SPD/Plastic drums to the outlet of Sifters with the help of twine. & Batch Size of the product. Sector-3.: PRODUCTION Review Date: 14-07-2009 Approved By . department it can be released for distribution. 5.C. report. manager issued. TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN Page : 02-03 STORE Deptt.…………………….4 Samples collected from the stores and sent to the Q.) STANDARD OPERATING PROCEDURE Asstt.C. Q/C Manager. Ltd.C. Karnal. Department. KARNAL-132 001 (HR.……….1 Goods laying in the factory goods distribution store. of concerned batch of the product.C.7 If the quality of the product during storage is found to have deteriorated / degraded to an extent that it is unfit for re-processing the same is destroyed with the permission of production director/ production manger in presence of representative of Q. Manager Sign. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Production Chemist Production Manager Q. department certificate to this effect in triplicate and Signed by the store in charge and Q. Manager to the store In-charge.A. 5. To lay down a Procedure for Handling of Finished Products in Store.…….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.5 If the product is found satisfactory by Q. one copy to be retained by the Signing authorities and third copy to be filled in the BPR. HSIIDC. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE Director Sign.………….… Sign. : 5. Department for analysis Within 15 days along with format test reports are reported.C.2 If the product has remained in the above stores for a longer period then on the request of store In-Charge.3 Random sampling is carried out by the in process supervisor in presence of Q. 5.C. 5. 5.: SPD/33 Effective Date: 15-07-2007 Revision No. officer in accordance with the statistical Production & for this purpose normal level of sampling to be done. Ltd.C.. Sign. Production Manager/Q.A. 5.SARTHAK BIOTECH Pvt. immediately after the receipt of the Q. The operation on the suitability or otherwise of product for distribution is also forwarded along with analysis report by Q.: PRODUCTION SOP No. 198-A.. Manager Director . Production Chemist Production Manager Q.……………………….C. the goods are sampled and subjected to stringent inspection and required analysis by Q.A.. Sector-3.6 If the results are unsatisfactory the product returned by the stores in charge to the factory for reprocessing and repacking if required. 1 Serial No.8. Department.6 Stock in hand. Manager Director . Manager. KARNAL-132 001 (HR.11 Products may be damaged during transport. 198-A.9.9.9 Sign. 5.C.10 Goods lying in branch ware /house company depots if any :- 5.A.8. Production Chemist Production Manager Q. 5.5 Date of receipt 5.………………………. 5.9.8. 5. 5. 5.4 Sample received from 5.9 Date of destruction of stocks.9. HSIIDC. The following particulars are entered in the register maintained by Q.2 Name of the product.6 Date of analytical report 5. Sign. Base on the type and extent of damage..: PRODUCTION SOP No.……….9.4 Quantity involved.3 Date of Mfg. It can be in the form of breakages without damage to content or physical damage. Ltd. & Date of Exp.9. 5.: SPD/33 Effective Date: 15-07-2007 Revision No.…….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.8.8.8 5.C.10 Signature of Q. TITLE: SOP FOR HANDLING OF FINISHED PRODUCTS IN Page : 03-03 STORE Deptt. The inchange samples the product as per sampling plan and send for Q.) STANDARD OPERATING PROCEDURE Sign. Department:5.7 QA Manager’s opinion 5.1 Serial No.C. Sector-3.8 Quantity destroyed.9.2 Name of the product. and Date of Exp. Branch or depot in-charge is decide the action.8.… Sign. 5. 5.9.5 Randomly sampled Quantity 5.. The following particulars are entered in the register maintained by stores:5.9.9. 5.3 Date of Mfg.………….SARTHAK BIOTECH Pvt.……………………. 5. ) STANDARD OPERATING PROCEDURE Sign.……………………. TITLE: SOP FOR PACKING OPERATION Page : 01-01 Deptt. based on the type and extent of damage.A.12 Goods lying in the transporter’s go-down or received back by the depot from market.…….13 The product inspected for physical damage. Sector-3. if any on receipt from the transporter’s go-down by the stores in-charge at the branch depot.: PRODUCTION SOP No. 5. KARNAL-132 001 (HR. Manager Director .………………………. HSIIDC. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. 198-A.: SPD/34 Effective Date: 15-07-2007 Revision No. Ltd. Sign.…………..14 If the product needs any re-dressing or reprocessing the same is subjected to treatment as above. The branch personnel are further action. 5.……….… Sign. 5. Sign.SARTHAK BIOTECH Pvt. SPD/12.1 After issue of packing material from warehouse. TITLE: SOP FOR CLEANING OF PASTE KETTLE Page : 01-01 Deptt.………. Sign.4 Before starting fresh batch all material required are brought and kept at relevant place only.: SPD/35 Effective Date: 15-07-2007 Revision No.………. Karnal.……………………. 1) PURPOSE : To lay down a Procedure for Packing Operation. Check identity of product & Quantity of product before starting of packing operation. inform Q. 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE Production Manager/Q. 5.) STANDARD OPERATING PROCEDURE Sign.…………………….5 Get the line clearance.…………. cartons and records is done as per SOP No.3 Before starting of operation the labels and cartons are checked for any defect.. Manager Director Sign. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5.8 Disposal of excess labels. 2) RESPONSIBILITY : Q/C Manager. 198-A. ..2 Store printed material properly 5.……. Sector-3.SARTHAK BIOTECH Pvt.A. KARNAL-132 001 (HR.9 Clean up the area at the end of days work. HSIIDC. 5.. Ltd.A. for their check. Sign.. Ltd..… Sign.……. check for identity and quantity. Sign.………………………. Sign.………………………. Production Chemist Production Manager Q.6 After packing is over. 5. 5. 5.7 Deliver the goods to the warehouse only on receipt of final approval from Q.…………. 5.A.A.: PRODUCTION SOP No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign. : 5. S. Production Chemist Production Manager Q. HSIIDC. Manager Director Sign.A.: PRODUCTION SOP No.……………………….. Ltd. Ltd..4 Mop with dry. lab. . 5. Container. 5. and S. Karnal.C. 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE Production Manager/Q. Sign. Then wash with fresh water until the detergent foam is completely washed out.: SPD/36 Effective Date: 15-07-2007 Revision No.……………………. 2) RESPONSIBILITY : Q/C Manager. Trays etc.) STANDARD OPERATING PROCEDURE 1) PURPOSE : To lay down a Procedure for Cleaning of Paste Kettle.…………. Scoops.S. Sector-3. 5. S.2 Wash with liquid soap or detergent with gentle rubbing. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.. are washed with water.A.1 The General Utensils like S.3 Finally wash with DM water and get wash utensils checked from the Q. TITLE: SOP FOR GENERAL CLEANING OF EQUIPMENT IN Page : 01-01 MANUFACTURING AREA Deptt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 198-A. clean cloth.……….… Sign. KARNAL-132 001 (HR. Sign.SARTHAK BIOTECH Pvt.……. : 5.S. 3 Clean all the machine parts using potable water. 5.K. Production Manager/Q.C.1 Check electrical terminals for insulation and soundness of terminal connections. Then rinse with potable water and then rinse with D. 5.: PRODUCTION SOP No. 5. Q/C Manager. . Ltd. : 5.……….6 After getting O.………………………. Check soundness of electrical switches and its contacts. put a tag on machine “CLEAN & READY FOR USE”. Karnal.A. HSIIDC. Sign. Department for analysis.2 At the end of the shift the equipment is cleaned.. Production Chemist Production Manager Q. Sign.M.A.4 Finally rinse with D.C.5 Wipe dry the surfaces. Manager Director Sign. 198-A.… Sign. Then wash with 0.: SPD/37 Effective Date: 15-07-2007 Revision No. using clean dry cloth. Water.1% Teepol solution. Sector-3.…………. Ltd.……. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5.. Department. KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE To lay down a Procedure for General Cleaning of Equipment in Manufacturing Area. TITLE: SOP FOR ADVERSE HEALTH CONDITION OF Page : 01-01 PERSON IN MANUFACTUEING AREA Deptt..SARTHAK BIOTECH Pvt.……………………. report from Q. water and send the wash water to Q.M. 5. ) STANDARD OPERATING PROCEDURE 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE To lay down a Procedure for Adverse Health Condition of Person in Manufacturing Area. TITLE: SOP FOR INTERNAL LABELING DURING Page : 01-02 QUARANTINE. STORAGE AND PROCESSING Deptt. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: SPD/38 Effective Date: 15-07-2007 Revision No.……………………….2 The production Deptt. Ltd.……. 5.. Production Manager/Q.SARTHAK BIOTECH Pvt. 5.………. Q/C Manager. Storage and Processing. Ltd. 198-A. Sign.1 The people who are sick & ill or suffering from any disease are not permitted in production area. the people are shifted outside the production area under medical aid. . Karnal. : 5. KARNAL-132 001 (HR.…………. To lay down a Procedure for Internal Labeling during Quarantine. 5.… Sign.: PRODUCTION SOP No..3 If any person feels discomfort in the production area or feel ill then inform immediately to concern supervisors / in-charge.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. allows sick leave to sick person.A.. Sector-3.4 As a fixed policy of organization. 1) PURPOSE : Sign. HSIIDC. Manager Director Sign.A. Production Chemist Production Manager Q.……………………. …………. Production Manager/Q. TITLE: SOP FOR INTERNAL LABELING DURING Page : 02-02 QUARANTINE.) STANDARD OPERATING PROCEDURE 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE Q/C Manager.5 Paste the following sticker on containers which are under operation. Sign. . Ltd. STORAGE AND PRICESSING Deptt. Karnal.SARTHAK BIOTECH Pvt.1 Paste “Material under Test” printed yellow sticker on all the containers.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sign.A.: PRODUCTION SOP No.3 Paste “Sampled” printed sticker on those containers.C..: SPD/38 Effective Date: 15-07-2007 Revision No. 198-A. of that material. Ltd. 5. 5.. whose content are sampled. which contain rejected material.2 Paste “Approved slip” printed green sticker on the entire container. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Deptt.4 Paste “Rejected” printed red sticker on those containers. Production Chemist Production Manager Q. 5.……. 5.A. which are under test. Sector-3. : 5. HSIIDC.……………………. of those material which are Tested by Q. KARNAL-132 001 (HR.………………………. Manager Director Sign.… Sign.……….. .SARTHAK BIOTECH Pvt. Sign.. Sector-3.3 IDENTIFICATION SLIP Name of Product ……………….……………………….. Date………………….A.……………………. Ltd. 5.: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE Sticker 1.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign. Date…………………… Remarks………………… Signature TITLE: SOP FOR RECEIPT OF PACKING MATERIAL IN Page : 01-01 PRODUCTION Deptt. Batch Size………………… Mfg. 4. 3. Production Chemist Production Manager Q. Exp.: SPD/39 Effective Date: 15-07-2007 Revision No. Manager Director Sign. 3. 198-A. 2. 6.. . HSIIDC.…….………. Sign. KARNAL-132 001 (HR. Batch No……………….…………. Karnal.SARTHAK BIOTECH Pvt. 5. : 5.……………………….: SPD/40 Effective Date: 15-07-2007 Revision No. HSIIDC. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 01-03 EXPIRED/ UNUSABLE MATERIALS Deptt. 198-A. Sector-3. Q/C Manager.2 Check and certify that the requisition slip is correct in all respect and get it authorized from production manager.……………………. Ltd.… Sign..…….8 Store the received labels in cupboard and other printed packing components in a locked room.………. KARNAL-132 001 (HR.………….A..3 Deposit in stores for issuing the packing material.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Manager Director Sign. Sign.) STANDARD OPERATING PROCEDURE 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE To lay down a Procedure for Receipt of Packing Material in Production.6 Acknowledge the receipt of material on requisition slip and file the departmental copy of BPR.5 Physically check and count all packing material received against requisition slip.: PRODUCTION SOP No. Production Chemist Production Manager Q. 5.4 Receive the issued material through the packing store material gate of production block.7 Stock the issue quantities properly in a manner to avoid damage due to over loading or fall down. 5. 5. 5.10 Store the adhesives in tight container. 5.1 Prepare requisition slip for the packing material.A. . 5. Ltd. Sign. Production Manager/Q. 5. 5. Restrict the access to this area.9 Segregate the similar looking packing components.. … Sign.………. Manager The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Sector-3.……………………. KARNAL-132 001 (HR.3) Unusable Materials: a) Information of such items. Q/C Manager. b) All rejected..2) Expired Materials: Input materials or finished product which has lost its credential due to non-usage for a period of over the years. Ltd.: PRODUCTION SOP No.: SPD/40 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt.A. c) Final product which fails to meet the standard. c) These materials are kept either in its original packing or in double poly bags duly knitted or sealed and bearing a sticker (red) with following informations. so that they can be identified and are physically separated from the other materials. Sign. Production Manager/Q. which have become obsolete due to change of process / packing materials. Sign. HSIIDC. Karnal. 198-A. 5. expired and unusable materials are pasted with red stickers.………….……. TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 02-03 EXPIRED/ UNUSABLE MATERIALS Deptt. which have lost its physical / chemical or biochemical properties. 5.A. : The procedure mentioned has deals with three categories of unusable materials:- Rejected Material: a) Which does not confirm the stipulated standard? b) Rejection during processing to store.) STANDARD OPERATING PROCEDURE 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : 4) SCOPE : 5) PROCEDURE 5. Manager Director Sign...1) To lay down a Procedure for Disposal and Salavage of Rejected / Expired / Unusable Material.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Ltd.………………………. Production Chemist Production Manager Q. . By________________________________________ Supplied By_____________________________________ Test Date_______________________________________ Analytical Report No.……….. of Q. From scrap yard the saleable items are sold through scrap dealers. Ltd.____________________________________ Date of Exp.____________________________________ Qty.___________________________________________ Mfg.…………. Production Chemist Production Manager Q._____________________________ Control Ref. Chemicals.) STANDARD OPERATING PROCEDURE RED COLOURED STICKER OF REJECTED MATERIALS SARTHAK BIOTECH Pvt. No__________________________________ Failed Parameter_________________________________ Sig. KARNAL-132 001 (HR.……………………. The record of disposal is maintained at production/ stores department. Sign.C. Sign. in the form of registers. KARNAL-132 001 D..SARTHAK BIOTECH Pvt.L. Ltd. Sector-3.. 198/A.……. Manager Director Sign. Raw materials.: PRODUCTION SOP No. TITLE: SOP FOR DISPOSAL & SALAVAGE OF REJECTED/ Page : 03-03 EXPIRED/ UNUSABLE MATERIALS Deptt.______________________________________ Date of Mfg.………………………. Person These materials are kept in a separate area in stores and periodically disposed off by either returning them to the supplier or sending them to scrap yard. Other materials are destroyed by burning. powders are drained out after proper treatment. 198-A. HSIIDC.… Sign.______________ Raw Material___________________________________ Batch No. .: SPD/40 Effective Date: 15-07-2007 Revision No.A. : 619 B (H) & 977 OSP (H) REJECTED Pack No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. HSIIDC. No. so that over the years. HSIIDC.D. a) Such materials are dumped in a closed 3’ x 3’ x 2’ (deep) pit by removing the cover/li b) The Pit contains earth. Production Chemist Production Manager Q. c) Every fortnight water is poured in the pit.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.……….……. .No. The record of such goods disposal are maintained in the following format. KARNAL-132 001 (HR. TITLE: SOP FOR THE WASTE COLLECTION FROM Page : 01-01 PRODUCTION AREA Deptt.… Sign. 1) PURPOSE : Sign.: SPD/41 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE All the salvage by burning is authentic carSed by the following person.…………. Sign.SARTHAK BIOTECH Pvt. Material Reason of non usage Qty. Date of Disposal /Salvage Signature of I/C Q.. Ltd. S. Sector-3. 198-A.A.……………………….: PRODUCTION SOP No.……………………. Manager Director Sign.A. the material become part of the earth itself. salt & Caustic Soda. 1) In charge of either Production / Stores (concurred deptt..) 2) In-charge of Production. Signature of I/C Prod Deptt Salvage of materials that release foul smell or toxic gases on burning. To lay down a Procedure for the Waste Collection from Production Area. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 2) RESPONSIBILITY : Q/C Manager. 3) ACCOUNTABILITY : Production Manager/Q.A. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. 5) PROCEDURE : 5.1 Clean any spoilage on shop floor immediately. 5.2 Empty the dustbin of packing department at an interval of every one hour. 5.3 Collect waste from all the sections in scrap yard. 5.4 Sort out the waste from packing section in presence of packing supervisor. 5.5 Dispose the waste into the scrap yard. 5.6 Destroy all scrap printed packing material by incineration in presence of quality assurance and security personnel. Record the destruction. 5.7 Lift the scrap from scrap yard every evening. TITLE: SOP FOR CLEANING OF CONVENTIONAL COATING Page : 01-02 PAN Deptt.: PRODUCTION SOP No.: SPD/42 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1) PURPOSE : 2) RESPONSIBILITY : Sign.…….………. To lay down a Procedure for Cleaning of Conventional Coating Pan. Q/C Manager. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 3) ACCOUNTABILITY : Production Manager/Q.A. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. 5) PROCEDURE : 5.1 As soon as the coating operation is over, remove the coated tablets in suitable containers. Remove the dry powder from the pan, if any. 5.2 Pour approximately 20 liters of hot water (80-85OC) into the pan and allow the pan to rotate for about 10 minutes. Remove this turbid water using a plastic mug and transfer it into a plastic bucket. Clean the inner surface of the pan with angular wooden brush having nylon bristles. 5.3 Place about 500g of sodium bicarbonate into this pan and gradually put about 20 liters of hot water (80-85OC) into the pan taking care that the eyes are well protected by goggles and full size PVC gloves are worm to cover arms. Allow the pan to rotate for 10 minutes. Remove this turbid water. 5.4 Place about 10 liters of warm water (40-45OC) into the pan. Allow the pan to rotate and continue to clean the inner surface of the pan with the angular wooden brush having nylon bristles. Remove the water and check that the inner surface of the pan is free from any powder of foreign particles. 5.5 Place approximately 10 liters of warm water (40-45 OC) into the pan and allow the pan to rotate for about 5 minutes. Remove this water. This rinse water is free from alkali. Repeat rinsing with 10 liters of warm water until the rinse water is free from alkali as indicated by a pH paper. 5.6 Allow the pan to rotate and wipe the inner surface of the pan with a lint free cloth. Look for any scratch pits on the inner surface of the pan. TITLE: SOP FOR CLEANING OF CONVENTIONAL COATING Page : 02-02 PAN Deptt.: PRODUCTION SOP No.: SPD/42 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.7 Sign.…….………. Cover the mouth of the coating pan with a nylon lid, affix the cleaning ticket indicating the following. - Equipment / Machine - Last Production - Batch No. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE - Cleaned and ready for product - Batch No. - Cleaned by - Date - Signature. 6) BLOWER ASSEMBLY: A B. PROCEURE FOR BATCH TO BATCH CHANGEOVER 1. Dismantling – Remove the blower pipe from the body. 2. Cleaning of blower pipe – Clean the blower pipe from inside and outside using compressed air. Wipe the external surface with a duster. 3. Cleaning of the blower body – Wipe the external surface with a duster. PROCEDURE FOR PRODUCT TO PRODUCT CHANGEOVER. 1. Dismantling – Remove the blower pipe from the body. 2. Cleaning of blower body – Clean the body surface, motor and fan using compressed air from outside as well as inside. Deduct the external surface with a duster. Wipe it with wet duster and dry it with a duster. 3. Cleaning of blower pipe – First clean it from inside and outside with a jet of potable water using a soft nylon brush. Then clean with 0.1% Teepol solution and again with a jet of potable water. Finally rinse with DM Water. 4. Drying of the blower pipe – a) Fix the cleaned pipe on the cleaned blower body b) Start the hot air blower. c) Adjust the temperature of the air to 100OC. d) Continue air flow till pipe gets totally dried. e) Switch off the heater of air blower and allow to cool to room temperature. TITLE: SOP FOR CLEANING OF FLUIDIZED BED DRYER Page : 01-02 Deptt.: PRODUCTION SOP No.: SPD/43 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.…….………. To lay down a Procedure for Cleaning of Fluidized Bed Dryer. Q/C Manager. Production Manager/Q.A. Manager 2.. Keep it in a polythene bag and send it for laundering to linen Deptt. 4 Cleaning of retarding chamber. Procedure for Product Changeover: 1. PROCEDURE : Drying is required to remove moisture from wet granulation.M. Dismantling: a) Detach finger bag from hook by opening Perspex windows in the retarding chamber. Karnal.………. d) Remove bowl. Water. Ltd. Fluidized bed dryer offers saving of time and labour thus increasing efficiency.………………………. TITLE: SOP FOR CLEANING OF FLUIDIZED BED DRYER Page : 02-02 Deptt. Sector-3.SARTHAK BIOTECH Pvt.……………………. Wash retarding chamber. It is better described as air diffusion drying system.Dedust individual finger chamber of finger bag..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. It is essential that the Production Manager confirm that the equipment is in clean condition before the same is used for any of the operations.A. b) Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley.: SPD/43 Effective Date: 15-07-2007 Revision No. A.) STANDARD OPERATING PROCEDURE 4) 5) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Take out trolley along with the finger bag and retarding chamber. in order to avoid cross contamination. KARNAL-132 001 (HR. Production Chemist Production Manager Q. Cleaning external surface and plenum: – Clean the body of the drier and plenum with a dry clean duster.………….: PRODUCTION SOP No. Manager Director Sign.……. HSIIDC.… Sign..1% Teepol solution followed by a duster soaked in D. Sign. Then wipe it with a duster soaked in 0. Ltd. c) Remove the finger bag. trolley and bowl – Take retarding chamber along with trolley and bowl to washing area. Sign. 3. Cleaning of finger bag. . Following cleaning and assembly procedure are followed whenever there is a product change over or after the completion of 10 batches of the product even if the same product granulation is to be continued thereafter. 198-A. 6) Wipe the interior of the retarding chamber and bowl with a clean dry duster. trolley.…………………….………. Water. Manager Director Sign.A. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. 5 Confirming effectiveness of cleaning – The DM Water rinse of retarding chamber and bowl is sent to Q. Note: 1) 2) B. Production Manager/Q.C.: PRODUCTION SOP No. Step No.1% Teepol solution.) STANDARD OPERATING PROCEDURE trolley with hot water scrubbing with clean nylon scrubber.A. To lay down a Procedure for Cleaning and Operation of Multimill. Lift the bottom of FBD. Department to confirm absence of previous product. Sign. Clamp the retarding chamber on the body with the fixed bolts. Production Chemist Production Manager Q.: SPD/44 Effective Date: 15-07-2007 Revision No. rinsing thoroughly with hot water followed by D. In case of sticky powder use steam. KARNAL-132 001 (HR.… Sign.………….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5 is a validatory exercise to be conducted at the time of product changeover. Manager . 6) Clean the interior surface of the retarding chamber.……. And seal the trolley with bowl to the retarding chamber.. Procedure for batch to batch changeover: 6) Clean the body of the drier and plenum with a dry clean duster. HSIIDC.SARTHAK BIOTECH Pvt. Then wash them 0.M.. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-04 MULTIMILL Deptt. Q/C Manager. 198-A. 6 Assembling – Fix the laundered finger bag in a metallic hanger around the retiring chamber.………………………. 6) Dedust the fingers of the finger bag. bowl. Ltd. Fix the ‘Cleaned Slip’ Label. Sector-3. c) The “MACHINE READY FOR USE” Sticker is removed and sticker/tag showing product. HSIIDC.…………. 5) PROCEDURE : The entire Machine Operation & Cleaning procedure is divided in three stages.. f) Below the chute. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-04 MULTIMILL Deptt.: SPD/44 Effective Date: 15-07-2007 Revision No. is put on the top cover of the machine. Sign.1 Pre-operative Cleaning & Setting. . d) Set the required size of sieve on the machine. etc. 198-A. 5. collection bag in fiber down is kept. Production Chemist Production Manager Q.………………………..2 Operation 5.……. STAGE – I a) The exterior of the machine is cleaned with dry cloth b) The electrical connections are restored by pulling the plug top into the socket. Sign.: PRODUCTION SOP No.SARTHAK BIOTECH Pvt. Sector-3. Ltd.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt..……………………. Manager Director Sign.… Sign. Karnal. g) The container containing 6. Batch No.3 Post Operative Cleaning and equipment preparation.A.wet) mass is brought near the machine.………. Ltd. KARNAL-132 001 (HR. STAGE – II a) The multi-mill is switched on and run for few seconds to observe whether if is running normally or not. 5. e) A plastic bag having two sides opening are tied to the delivery chute.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. l) The granulated mass is collected in the poly bag kept in fiber drum. Sign. STAGE – III .) STANDARD OPERATING PROCEDURE b) Fix knives in rotor as per requirement of sizing i. Sector-3.………………………. n) If further granulation of the same batch is required it is continued. ‘impact edge’ or ‘knife edge’ forward.…………. c) Ensure that blades fixed in the rotor are in 4.C. d) Fix the rotor with blades to the central rod of multimill with rotor fixing screw.… Sign. 4. Sign. for rectification. so as to get required speed fast. e) Fit the required intact screen base plate on multimill properly tightening two side’s nuts. f) Fix the belt on the appropriate wheel of the pulley. sequence and none of the blades are missing. i) Fix the feeding hopper and cover it with lid. Manager Director Sign.: PRODUCTION SOP No.e.……….……. o) In case of batch changes the contact parts are cleaned by clean cloths. medium or slow.D. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 03-04 MULTIMILL Deptt. g) Check the knives of the rotor are not touching the screen by turning the belt by hand. 3. HSIIDC. Ltd.…………………….: SPD/44 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt. Fix the key to the central shaft. 3. m) The process is continued till the entire mass is granulated. h) Close and lock the milling chamber guards. 198-A.A.. Production Chemist Production Manager Q. KARNAL-132 001 (HR. p) In case of Product or composition change the entire m/c is washed and wash water analysis is to be done to by Q. j) If any abnormal sound is heard the machine is referred to maintenance dept. render the m/c ready for further use. k) In other case the machine is started and the mass is put on the hopper slowly and gradually. Give proper tension to the belt by moving movable pulley apart and lock it in position..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. ) STANDARD OPERATING PROCEDURE a) After the day’s operation or Production change or change of composition all the contact parts like cutter knives. h) A sticker starting “MACHINE READY FOR USE” is put on the machine to render it ready for use. switch off the mill and the untie the poly bag from the mill chamber.D. Finally wash with D. screen. Sector-3. A logbook is kept for each machine of aeration in the following format: LOG BOOK OF MACHINE/EQUIPMENT .: PRODUCTION SOP No. Inform the maintenance department of the problem. Production Chemist Production Manager Q. b) Place a new polythene bag in a clean plastic container and tie to the bottom of the multi-mill chamber. NOTE: The dismantled parts are cleaned on the same day of the operation. cover and hopper etc. NOTE: When the container is full. 198-A.A. If any unusual noise is heard during the milling operation.D. for testing.………. f) Once the wash water analysis is cleared by Q.……………………. always fixing the container in similar manner to the discharge chamber of the mill e) At end of the milling operation.…………. are thoroughly cleaned using liquid soap/detergent and wash the machine till foam of detergent/liquid soap completely washed out... Ltd.C.… Sign. Manager Director Sign. HSIIDC. do not dismantle but tie a fresh poly bag on bottom of milling chamber.……. Quarantine the mill as well as the container pending further packing.C. switch off the mill and disconnect the electrical mains. c) Load the material to be milled into feeding hopper by means of a clean SS scoop with handle.………………………. Sign. Sign. awaiting a new load for milling. stop the machine to remove the receiving container. KARNAL-132 001 (HR.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. If the mill is to be used the same product. Dismantle the mill and note the cause of noise.SARTHAK BIOTECH Pvt.: SPD/44 Effective Date: 15-07-2007 Revision No. Tie the bag and fix appropriate ‘label’ to the container. Repeat the procedure as often as required. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 04-04 MULTIMILL Deptt. d) Switch on the main switch and start milling.M. g) Taking out the plug top then cuts off the connection from the socket. The contact parts and other parts are moped and dried. water and wash water is sent to Q. A.………………………. : .………. Production Chemist Production Manager Q. KARNAL-132 001 (HR. 3) ACCOUNTABILITY : Production Manager/Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.……. Ltd....A. Karnal.: SPD/45 Effective Date: 15-07-2007 Revision No.. Manager Director Sign.SARTHAK BIOTECH Pvt. Machine/Equipment Code: SOP No.: SPD/10 Location:………. 1) PURPOSE : To lay down a Procedure for Cleaning of Polishing Pan..………. Sign.. Sign. Operated By Checked By TITLE: SOP FOR CLEANING OF POLISHING PAN Page : 01-01 Deptt... Sector-3.: PRODUCTION SOP No.………….. Manager 4) SCOPE The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.....………. HSIIDC.…………………….:………..) STANDARD OPERATING PROCEDURE Name of Machine/Equipments: MULTIMILL Page No. 198-A..… Sign. Ltd. 2) RESPONSIBILITY : Q/C Manager. Date Start Time Finish Time Total Hours of Running Break Down START END Down Time Hours Production/ Batch No. .6 Cover the equipment with a fresh cloth over till the commencement of the next operation. 6. Carry out the cleaning operation as follows: 6. Ensure that the other equipment in the polishing room such as tray drier. Sector-3.…………... 6. Manager Director Sign.) STANDARD OPERATING PROCEDURE 5) 6) PRECAUTION : Wear rubber gloves. KARNAL-132 001 (HR. Ltd.… Sign. 6. remove the polished tablets in a suitable poly – lined aluminium containers. 6. goggles and protective clothing during this procedure.……. 6. Karnal. 198-A. CLEANING : . Ltd.3 Remove excess wax by scrapping with the knife and then clean with a nylon brush.……………………. HSIIDC.A. Q/C Manager.2 Vacuum cleans the inside of the pan to remove loose particles.7 Affix a ‘Label for Cleaning’ indicating the following. - Equipment/ Machine - Last Product - Cleaned and ready for Product - Cleaned by - Date - Signature TITLE: SOP FOR CLEANING AND OPERATION OF CAPSULE Page : 01-02 FILLING MACHINE (SEMI-AUTOMATIC) Deptt.1 Remove all the identification of previous batch.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.4 Remove the canvas cloth. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.: SPD/46 Effective Date: 15-07-2007 Revision No. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of Capsule Filling Machine (Semi-Automatic). PROCEDURE : TABLET: As soon as the polishing operation for a particular batch of coated tables is over.SARTHAK BIOTECH Pvt. Production Chemist Production Manager Q.: PRODUCTION SOP No.……….A.………………………. Manager 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 6. Label these containers appropriately and store these containers in the quarantine. Sign. Sign. multimill.5 Apply a fresh coat of wax ( White Bees Wax dissolved in Chloroform). trolley etc is suitably covered. . HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Rinse with potable water followed by rinsing with DM water.A. Remove the filter bag of the vacuum placed behind the machine. Rinse with potable water followed by rinsing with DM water. 6.……. 6) Sign. reassemble the capsule machine for filling of next batch (Product). “READY FOR USE”.3 Clean the capsule plates by soaking in hot water for 10 minutes.6 The cleaned parts are dried using clean lint free cloth. Sector-3.. Then rinse with potable water. 6.… Sign.3 Fix the Guide Plate on the machine.) STANDARD OPERATING PROCEDURE 5.2 Clean the parts by washing with 0.……………………. Manager Director Sign.: PRODUCTION SOP No. 198-A.5 The DM water rinse of capsule plates is sent to QC Department to confirm absence of previous product.2 After getting QC report. OPERATION: 6.: SPD/46 Effective Date: 15-07-2007 Revision No.1 After receiving the QC report fix a label. 5.1% Teepol solution.…………..1% Teepol solution & scrubbing with soft nylon brush. Sign. 5.………. 5.1% Teepol solution and scrubbing with soft clean nylon brush. Ltd.1 Dedust external surfaces using clean nylon brush. 5. KARNAL-132 001 (HR.SARTHAK BIOTECH Pvt. 5. The holes are cleaned using 0.………………………. Production Chemist Production Manager Q.4 Clean the machine body with 0. The capsule plates are air dried TITLE: SOP FOR CLEANING AND OPERATION OF CAPSULE Page : 02-02 FILLING MACHINE (SEMI-AUTOMATIC) Deptt. ………….. 2) RESPONSIBILITY : Q/C Manager. Manager Director Sign. remove the filled capsules.………. PRECAUTIONS: Rejected capsules are separately packed in a corrugated carton and labeled as “REJECTED” and transferred to quarantine area. 6.… Sign. 5) PROCEDURE : . Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.5 Press the top plate on filled magazine. Put the powder on the capsule magazine. Ltd.A.9 Record the machine cleaning / operation in record.………………………. 198-A.. till the batch is finished. Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Ltd. Sign. spray the powder by a plastic made spreader. 6. KARNAL-132 001 (HR. Format.……………………. HSIIDC. TITLE: SOP FOR CLEANING OF SPRAY GUN Page : 01-01 Deptt. Karnal.A. 6.SARTHAK BIOTECH Pvt.8 Continue the same process.. and lock the plate by pressing with handle.) STANDARD OPERATING PROCEDURE 6. 1) PURPOSE : To lay down a Procedure for Cleaning of Spray Gun.6 Load the caps part of the capsules.: PRODUCTION SOP No.4 Weigh qty.: SPD/47 Effective Date: 15-07-2007 Revision No.……. 6. Production Chemist Production Manager Q. of powder to be filled for 300 capsules. 3) ACCOUNTABILITY : Production Manager/Q. Sector-3.7 Loosen the lock bolt. 6. Dip the gun is SS bowl containing hot potable water. Dismantle parts of the gun (aircap/needle/nozzle). f. 5.SARTHAK BIOTECH Pvt. TITLE: SOP FOR CLEANING OF TABLET DEPARTMENT Page : 01-02 Deptt.4 Storage: . 5. Ltd.……………………. Scrub the external surface of gun air cap and needle with 0.) STANDARD OPERATING PROCEDURE 5. KARNAL-132 001 (HR.. Sign. e.… Sign.………. Send the wash water sample for analysis..Remove the gun from stand. Mop with nylon brush. 2) RESPONSIBILITY : Q/C Manager. g. Karnal.3 Drying of the Gun body: – Wipe the dismantled part and body of the gun with lint free duster. Sign.: PRODUCTION SOP No. 3) ACCOUNTABILITY : Production Manager/Q.: SPD/48 Effective Date: 15-07-2007 Revision No.A. Sector-3.…….……………………….Store the gun and its part in an appropriate clean poly bag until use. d. Manager Director Sign.…………. 1) PURPOSE : To lay down a Procedure for Cleaning of Tablet Department. Ltd. reassemble the parts.1% Teepol solution.A. 5. c. Rinse thoroughly with running water.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.2 Cleaning of gun: a. After getting analysis report. Manager 4) SCOPE The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Rinse with potable water. Production Chemist Production Manager Q.. b.1 Dismantling: . 198-A. : . for about ½ hour. Finally clean it with DM Water. HSIIDC. 198-A.……………………. Sector-3.A.: PRODUCTION SOP No. 8) AREA COVERED: Granulation. CAUTION: No cleaning operation is carried out while processing of a product is on in any of the manufacturing sections like granulation. Cleaning and disinfection of the non-sterile manufacturing area is a primary requirement of GMP and is of utmost importance since the particles are continuously generated during the operations contaminating the entire area. The viable /non viable particles settling on the equipment not in use. vacuum cleaner and mechanical cleaners are used accordance with the requirements in each area.……. This is essential keeping in view the need to preclude any contamination of formulation processed in the manufacturing area. 9) Sign.………………………. floors may lead to potential cross contamination if the effective cleaning procedures are not followed. individual equipment covered with the cloth cover with the appropriate status label as soon as processing on that particular equipment is over. Same practice is followed for other manufacturing area. Manager Director Sign. Ltd. drying compression. All the equipment /machines are covered with fresh cloth covers and labeled appropriately. TITLE: SOP FOR CLEANING OF TABLET DEPARTMENT Page : 02-02 Deptt. In granulation department. 6) FREQUENCY: Cleaning and disinfection of the non-sterile area used in order to prevent development of resistant strains of the common contaminating microorganisms. Production Chemist Production Manager Q. walls.…………. tablet compression areas etc. coating. Sign.……….SARTHAK BIOTECH Pvt. . HSIIDC. strip & blister packing and passages.: SPD/48 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. As soon as the entire processing activity is over. 7) CLEANING EQUIPMENT: Various equipment such as floor mops.… Sign.. KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 5) PURPOSE : Cleaning of the floor and wall surfaces in the non-sterile manufacturing area help in removal of the accumulated dust disinfection of the area. the granulation area cleaned as per the procedure laid down below.. coating. the vacuum cleaner is used. Production Chemist Production Manager Q.. Manager Director Sign. Dettol 5% and Lysol 1.………. c. f.A. 2) RESPONSIBILITY : Q/C Manager. e. TITLE: SOP FOR PASTE PREPARATION VESSEL Page : 01-01 Deptt.… Sign. 12) PROCEDURE: a.5%. KARNAL-132 001 (HR. b. Any spoilage of the materials are cleaned up as soon as it takes place. Manager .…….) STANDARD OPERATING PROCEDURE 11) CLEANING AGENTS AND CONCENTRATION: Phenyl 0.A. HSIIDC. The entire floor is then cleaned with water and disinfecting agent of the specified concentration and subsequently the floor is dried. Initially clean with vacuum cleaner all the floor and wall edges to dislodge any accumulated dust in the crevices. Whenever the product changeover takes place. 3) ACCOUNTABILITY : Production Manager/Q. Sign. For this. the Production Manager carefully inspect all the areas and ensure that there is no residue of the previous product and the entire area is ready for use for the subsequent product operation. Ltd.………………………. 198-A. d..: SPD/49 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt.……………………. 1) PURPOSE : To lay down a Procedure for Paste Preparation Vessel.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Cleaning of the floors and the walls is done at the end of the day or shift only after all the equipment/ machine / containers have cleaned and suitably covered.0%. Sign. The tracking of powders from one area to the other caused by the Footwear of the personnel therefore the Personnel is instructed to clean their footwear intermittently. Cleaning agent to be changed every fortnight. Sector-3.: PRODUCTION SOP No.…………. HSIIDC. To lay down a Procedure for Disposal Operation in Tablet Department. 5. Q/C Manager.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.3 Light up the burner of the stove. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.…………. 198-A. 5.……….. Manager .6 Unload the cooked paste into suitable container. Ltd. Ltd. Production Chemist Production Manager Q. Manager Director Sign. 5. 5. Sign.1 Check that the knob of gas cylinder is closed.: SPD/50 Effective Date: 15-07-2007 Revision No.……………………….A.SARTHAK BIOTECH Pvt.2 Pour the required quantity of material into the vessel as per sequence specified in the product batch manufacturing record. KARNAL-132 001 (HR.7 Clean the paste vessel daily as per defined standard operating procedure.4 Close the knob of the cylinder after attaining suitable temperature. Production Manager/Q.. Karnal.……………………. Sector-3. 5.A.… Sign.5 Allow the prepared paste to cool to room temperature 5.…….: PRODUCTION SOP No.. TITLE: SOP FOR DISPOSAL OPERATION IN TABLET Page : 01-01 DEPARTMENT Deptt. 5. 198-A. Production Chemist Production Manager Q.A.: PRODUCTION SOP No. Sector-3. Put it in a poly bag and then discarded by putting it in water. Ltd. Manager Director Sign.……. Production Manager/Q. Karnal.: SPD/51 Effective Date: 15-07-2007 Revision No. All In-process checked tablets during compression and coating are destroyed in Bucket of water.2 LABELS: Discarded labels are collected in container labeled as “Used Poly Bags” slip and send to scrap yard along with poly bag by house keeping person.3 REJECTED TABLETS: Rejected tablets during the initial run from compression machine are destroyed in a bucket of water. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. These materials are then transferred to scrap yard for destroying. KARNAL-132 001 (HR.A. 5. Discarded punches. Labels of dispensed raw material are teared off and then discarded as above only after the batch is released for packing. sieves and screens are handed over to stores on the scrap note after approval by Production & Safety In-charge.………. Ltd. Manager .1 POLYTHNE BAGS: All discarded poly bags are collected in container labeled as “Used Poly Bags” slip and send to scrap yard. To lay down a Procedure for Cleaning and Assembling of Compression Machine Q/C Manager.4 DUST: Dust is collected by vaccum cleaner and machine dust collector. bowl cover.………………………. 5..SARTHAK BIOTECH Pvt.. HSIIDC. TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 01-03 COMPRESSION MACHINE Deptt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign.………….) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. The embossed punches are to be defeated under the supervision of Production Manager.……………………. damaged finger bags. Sign.. 5. Clean all the above mentioned parts along with relevant bolts thoroughly with hot tap water and keep them aside. Ltd.). first with a dry nylon brush and then with denatured spirit (70% I.………. cam tracks.: PRODUCTION SOP No. As soon as the compression of a particular batch is over.P.… Sign.. - Turret guards - Cover plate of the worn shaft. Remove all the dies with the help of SS rod and keep them serially arranged in a one of the above trays. Following procedure is adhered to: 1) Disconnect the electric supply 2) Dismantle carefully the following parts: - Feed hopper - Acrylic guards - Feed-frames.……………………. TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 02-03 COMPRESSION MACHINE Deptt. . Sign.SARTHAK BIOTECH Pvt. Production Chemist Production Manager Q. Manager Director Sign.…….. b) Sign. Karnal. Clean all the interior area of the machine like base plate on which the turret is fitted. Sector-3. HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. die seats .A.. a) Remove carefully all the lower punches by removing the plug and keep these punches in a specially designed wooden tray. Ltd.: SPD/51 Effective Date: 15-07-2007 Revision No. KARNAL-132 001 (HR.………………………. clean the entire exterior of the machine as well as the room.A.…………. Care are taken with cleaning the punch hole and die sets so that they are free from any particulate matter. upper and lower punch holes turret surface. 198-A. - Nylon break plugs along with the spring steel strips - Die screws - Tablets collecting chutes. Similarly remove all the upper punches and keep them in a separate wooden tray serially arranged. serially arranged. : SPD/51 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. If required use additional distilled water to get the “clear” rinse water.2 Sign. KARNAL-132 001 (HR. Put the plug back into its position.. Manager Director Sign. . 5.… Sign. f) Wipe all the cleaned parts from step ‘e’ with a clean dry lint free cloth. Sector-3..A.Before the dies are fitted. HSIIDC. All the lower punches thus introduced are move freely up and down.SARTHAK BIOTECH Pvt. FITTING OF LOWER PUNCHES: -Take a lower punch and wipe its dry smear with liquid paraffin and introduce it through the lower punch die hole taking care that each numbered punch goes into its corresponding compression station.1 FITTING OF DIES: . Inspect the final rinse water for absence of any suspended matter.…………. Once the die is fitted the top portion of the die flushed with the turret surface.……. After locating the die correctly. Fix all the cleaned and dried nylon plugs with spring steel strips. then in Teepol mixture and then cleaning thoroughly with hot DM water. After cleaning all the punches and dies should be put serially in the clean wooden trays meant for storing them. drive the die position with the help of SS rod introduced through the upper punch guide holes. Production Chemist Production Manager Q.: PRODUCTION SOP No. Sign. TITLE: SOP FOR CLEANING & ASSEMBLING OF Page : 03-03 COMPRESSION MACHINE Deptt.) STANDARD OPERATING PROCEDURE c) Wipe clean the exterior of the machine with a lint free duster. 10% Teepol (non toxic detergent solution) mixture and clean all the punches by dipping each in hot water.………………………. Apply light pressure with fingers on the top phase of the die to locate centrally over the die hole. 5. ensure all the die seats are free from any foreign matter place the die face downwards on the die hole. d) Cleaning and fitting of dies and punches Take out 2 liters of hot tap water.……….……………………. e) Use 15 liters of distilled water to give couple of washing to the cleaned parts and the dismantled punches and dies. 198-A. Ltd. . Fit the cleaned and dried feed frame at their respective positions. 3) ACCOUNTABILITY : Production Manager/Q. Affix a cleaning ticket indicating the following:- - Equipment / machine - Last Product- Batch No. 198-A. Manager .: SPD/52 Effective Date: 15-07-2007 Revision No.…………. KARNAL-132 001 (HR. Manager Director Sign.A. Production Chemist Production Manager Q.) STANDARD OPERATING PROCEDURE 5.3 FITTING OF UPPER PUNCHES: -The cleaned and dried upper punches are smeared with liquid paraffin and introduced them in to their respective holes: A) Put back all the turret guards after wiping them dry.A. Sector-3..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sign.: PRODUCTION SOP No. 1) PURPOSE : To lay down a Procedure for Tablets Compression Tooling. 2) RESPONSIBILITY : Q/C Manager. Ltd. - Cleaned and ready for production- Batch No.……. Install the cleaned and dried acrylic guards and hoppers in their relevant position. - Cleaned by - Date Supervisor Signature TITLE: SOP FOR TABLETS COMPRESSION TOOLING Page : 01-01 Deptt.… Sign. B) Cover the cleaned machine with a clean cover.……….SARTHAK BIOTECH Pvt. HSIIDC.………………………. Sign.……………………. ………. Ltd.A. The quality of the tablet significantly dependent on the condition and quality of the tooling used for compression. The tablet compression tooling consist of a set having I upper punch.1 TOOLING USE LOG:Date Product Est. of tablets compressed (in lacs) Initials of Supervisor TITLE: SOP FOR STORAGE OF IN-PROCESS TABLETS & Page : 01-01 GRANULES Deptt. KARNAL-132 001 (HR. Karnal. lower punches & dies) Date on which the tooling set was put to use 5. Manager .………………………. of upper punches.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.SARTHAK BIOTECH Pvt.…….……………………. I lower punch and die. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.. 198-A. Production Chemist Production Manager Q. Manager Director Sign. Ltd. Name of the Compression Machine (for which tooling set is to be used) Name of the product (for which tooling set is to be used) Number of Upper Punches Number of Lower Punches Name of the manufacturer (of the tooling set) Date of the manufacturer ( of the tooling set) Details of tools received (No.. HSIIDC. To lay down a Procedure for Storage of In-process Tablets and Granules. Production Manager/Q.A.: SPD/53 Effective Date: 15-07-2007 Revision No. The concerned Production Manager maintain the following data of the compression machine (for which the tooling is to be used.: PRODUCTION SOP No.… Sign. Sign. Sector-3.. No.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.…………. Q/C Manager. The containers are transferred to quarantine area and stores in stacks of four containers not more than three rows per batch having label on the front side of the containers. HSIIDC. batch no.………. KARNAL-132 001 (HR. S. up to approx.… Sign.……. A label indicating product. These containers then transfer to quarantine area and stored on SS pallets in 2 roll with maximum height of 2 containers having label on the front side. Manager .. Ltd. and consequently the net wt. of tablets. B) TABLETS: . Manager Director Sign. Sector-3.SARTHAK BIOTECH Pvt..……………………….Compressed tablets from the machine are stored in suitable no.: PRODUCTION SOP No. pre weighed aluminium / plastic containers with polythene bags. of the containers for the batch. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.: SPD/54 Effective Date: 15-07-2007 Revision No. 80-90% holding capacity of the bags to facilitate proper tying with twine. Batch No. the lubricated granules are unloaded in suitable no. 80-90% holding capacity of the bags to facilitate proper tying with twine.No. Ltd.A. of container & total No..A. of Pre-shifting weighed aluminum / plastic containers with polythene bags. of the containers for the batch are affixed on the inner side of the lid and one on the exterior of the container. To lay down a Procedure for Operation of Fluidized Bed Dryer.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.No. S. Production Manager/Q. The containers of different batches are segregated. Karnal. The label which are affixed on the inner side of the lid and on the exterior of the container with the detail about product.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. TITLE: SOP FOR OPERATION OF FLUIDIZED BED DRYER Page : 01-02 Deptt.…………. Sign.. Production Chemist Production Manager Q. Q/C Manager. up to approx.……………………. At the end of the compression process all containers are weighed again to determine gross wt. 198-A. A) GRANULES: -At the end of granulation process. of granules. of container & total no. All the containers are weighed again to determine the net wt. of labeled. 4. HSIIDC. . Manager Director Sign. 3. 198-A.……………………….… Sign.. Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Check and certify that area and equipment are clean and suitable for starting the operation. ASSEMBLING: 1. Sector-3. 5.. KARNAL-132 001 (HR. Check and certify the suitability of the clean finger bag. Load the bowl with material to be dried. Ensure that main switch is in ‘OFF’ position before dismantling FBD for loading. OPERATION: 1. Clamp the retarding chamber on the body with fixing bolts.A. Production Chemist Production Manager Q. Fix the finger bag in a hanger. B.: SPD/54 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : CAUTION: i) The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.…………………….: PRODUCTION SOP No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sign. Fix the loops of the finger to the hooks of the shaker. Ltd.………….……. TITLE: SOP FOR OPERATION OF FLUIDIZED BED DRYER Page : 02-02 Deptt. 2.………. Take the product uniformity in the bowl to avoid lumps. ii) A. Take out trolley along with the retarding chamber. 2. Place the bag in between retarding chamber and fluidization chamber. Karnal.SARTHAK BIOTECH Pvt. Ltd. Sign.. Sign. 7.. Lift the bottom of the FBD moving the jack handle to the opposite side and seal the trolley to the retarding chamber. UNLOADING: 1 After drying is complete put off main switch. Position the bowl.SARTHAK BIOTECH Pvt.: SPD/55 Effective Date: 15-07-2007 Revision No.A. 11. Stop drying at intervals and dedust the finger bag by shaking it. HSIIDC. Watch the fluidized flow through the Perspex window. 2 Shake the finger bag vigorously and dedust retarding chamber..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 6.……………………. Check and ensure that there is no leakage.……. 4. maintaining the desired inlet air temperature. Ltd. 8. C. Production Chemist Production Manager Q.… Sign. 12. 5. Q/C Manager. Sector-3. KARNAL-132 001 (HR. Manager Director Sign. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Take out trolley and shake the granules to avoid formulation of lumps 10. Move the product bowl in the retarding chamber keeping the window in viewing position. Continue heating until required outlet air temperature is achieved. Production Manager/Q.………. Manager . To lay down a Procedure for Cleaning and Operation of Mass Mixer. 198-A.…………. Put off the heaters and bring the timer to zero. Set the timer and switch on heating and fluidization.: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE 3. TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 01-03 MIXER Deptt.………………………. 3 Unlock and withdraw the bowl.A. 9. . k) Protect the mixer from atmosphere dust by using polythene bag.……….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. I) Pre-operative Cleaning & Setting. h) Collect the rinse of the final checking and send to QC Department for checking of contamination from previous product.: SPD/55 Effective Date: 15-07-2007 Revision No. g) Remove the water and rinse with fresh DM Water and dry it by using clean muslin cloth. . Production Chemist Production Manager Q.… Sign..A.…………. To it add 100 ml of Teepol solution and run the mixer for 15 minutes.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. j) Cover the mixer lid. e) Pour approximately 100-liter water into the mixer. HSIIDC.………………………. Sign. to remove adhered lumps of powder. l) Clean the mixer prior to use to manufacturing operation. TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 02-03 MIXER Deptt. Blade. 5) PROCEDURE : The entire Machine Operation is divided in three stages.SARTHAK BIOTECH Pvt. Cover and inner & outer surface of the machine is cleaned with dry cloth. b) The electrical connections are restored by pulling the plug top into the socket. Ltd.. when in use. KARNAL-132 001 (HR.: PRODUCTION SOP No. II) Operation III) Post Operative Cleaning and equipment preparation. Stage – I a) The shaft. Then use nylon brush to remove any adhered material. Sector-3. i) Paste the specified ‘CLEAN SLIP’ label after getting approval from QC Department. Sign. Karnal.……………………. Manager Director Sign. 198-A. f) Ensure that no material is adhered to the corner and edges of the shaft. keeping it in tilting position.……. Ltd. c) Clean the lid and vessel of the mixer with tap water. d) The mixer is rinsed with hot tap water. for 30 minutes). d) After mixing the content for required time (e. Sign. Stage – III a) After the day’s operation or Production change or change of composition all the parts like mass mixer cover.C. is put on the top cover of the machine. c) In other case the Bulk (Sieved powder) put into the mass mixer. machine then add the binder (paste).A. shaft blade & joints. Sector-3.D. covers the machine and starts the machine. for rectification.identity slip) showing name of product. render the machine ready for further used.………………………. TITLE: SOP FOR CLEANING AND OPERATION OF MASS Page : 03-03 MIXER Deptt.SARTHAK BIOTECH Pvt.g.………. This wet mass is now ready for milling.…………. PRECAUTION: A) Ensure that micro switch is in proper working condition.… Sign. . B) Never run the mixer with the lid open continuously. surface (inner & outer) etc.……. KARNAL-132 001 (HR. Stage – II a) The Mass Mixer is switched on and run for few seconds to observe whether it is running normally or not. Sign. Collect out the mass in S.: SPD/55 Effective Date: 15-07-2007 Revision No. f) If further granulation of the same product is required it is continued.……………………. Stop the e) Run the mixer for further 15 minutes and get the required wet mass.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. 198-A.. Ltd. HSIIDC. b) If any abnormal sound is heard the machine is referred to maintenance deptt.) STANDARD OPERATING PROCEDURE m) The “MACHINE READY FOR USE” Sticker is removed & sticker/tag 6. Container.S. Batch No. g) In case of product or composition change the entire machine is washed and wash water analysis is to be done to by Q. Manager Director Sign.: PRODUCTION SOP No. Production Chemist Production Manager Q. etc. d) A sticker starting “Machine ready for use” is put on the machine to render it ready for use..…………………….: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE are thoroughly cleaned and washed. are moped and dried. Sign. Production Chemist Production Manager Q.. cover. ______ Finish Time Total hrs. 1) PURPOSE : To lay down a Procedure for Tablets Inspection.……………………….D. b) Once the wash water analysis is cleared by Q.… Sign. 2) RESPONSIBILITY : Q/C Manager.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. for testing. blade shaft etc. 198-A.………….: SPD/56 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt. 3) ACCOUNTABILITY : Production Manager/Q.A. Final washing to be done by D. Manager Director Sign. Ltd. The Mass Mixer surface (inner & outer). KARNAL-132 001 (HR. Manager . ________ Date Start Time Page No.C. Sign. water and wash water sent to Q.………. c) The connection is then cut off by taking out the plug from the socket. HSIIDC.D. of running Breakdown Start End Down Time hrs.…….C. Sector-3.M. TITLE: SOP FOR TABLETS INSPECTION Page : 01-01 Deptt.A. Product & Batch No. A logbook is kept for each machine of aeration in the following format: LOG BOOK (Mass Mixer) Machine No. To lay down a Procedure for House Keeping in Tablets Compression Section.…………………….………. Production Chemist Production Manager Q.3 A label having details about product Batch no. Production Manager/Q. Ltd.4 Checker for the inspection of the tablets are changed after every four hours.A. 5.……………………….A.. 5. Manager Director Sign.: PRODUCTION SOP No. gloves are changed after every four hours.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd. TITLE: SOP FOR HOUSE KEEPING IN TABLETS Page : 01-01 COMPRESSIONS SECTION Deptt. Karnal. of the new product to be inspected is affixed on the table at which the inspection is done. Q/C Manager. 5.1 Before starting the new product / batch.… Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.………….……. KARNAL-132 001 (HR.6 Proper record are maintained of rejected tablets and type of rejection found as per SOP. HSIIDC...5 Clean cotton gloves are used for inspection of tablets. tablets from the previous product/ batch are removed from the inspection area. 5. 198-A.: SPD/57 Effective Date: 15-07-2007 Revision No. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Sector-3. are removed from the inspection area. Sign.SARTHAK BIOTECH Pvt. Manager . 5.2 All the containers etc. 5. Karnal.SARTHAK BIOTECH Pvt. TABLET COMPRESSION AREA: 1) Ensure that all the compressed tablets of the previous product / batch have been removed.: SPD/58 Effective Date: 15-07-2007 Revision No. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.. Sector-3.………. HSIIDC. for proper cleanliness and for the label having details about Product Batch No. Q/C Manager.: PRODUCTION SOP No.……………………. 2) With the help of a vacuum cleaner remove all the dust accumulated on the floor. 4) All the accessories of the DT apparatus and weighing balance are properly cleaned before commencing compression of the next product / batch.. Ltd.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Manager Director Sign.A. walls and the exterior surface of the machine 3) Clean all the SS plates as well as the floor with the help of a wet mop. Sign. Ltd. Production Chemist Production Manager Q. KARNAL-132 001 (HR. 5) Inspect the empty aluminium / plastic containers and the polythene bags designated for the product to be compressed. TITLE: SOP FOR HOUSE KEEPING IN TABLETS PACKING Page : 01-01 AREA Deptt..A. and Serial No.………………………. 6) Ensure that the compression operator wears proper hand gloves. cap and mask.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. of containers etc. Manager . 198-A.……. To lay down a Procedure for House Keeping in Tablets Packing Area.…………. Production Manager/Q.… Sign. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : 5.1 The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. TABLET PACKING AREA:5.1.1 Ensure proper line clearance before starting packing operation for the next product / batch. 5.1.2 All packing material including over printed material received in full quantity as per indent before starting of any packing operation for the next product / batch. 5.1.3 All the packing material and the bulk tablets are stored in such a way that the product identification is easy and movements of these materials do not lead to accident and hindrance to the movement of personnel. 5.1.4 With help of vacuum cleaner, all the dust on the floor as well as walls and exterior of strip/ blister-packing machine is be removed periodically. 5.1.5 All employees working in the packing area wore clean uniforms. Operator responsible for running the strip-packing machine wore hand gloves and face mask. 5.1.6 At suitable intervals the floors is cleaned by the janitors to clear any spoilage of bulk tablets/ packing materials. Trashes from dustbins are removed regularly. Spoilage of any liquid on the floor should be immediately cleaned and floor should be wiped dry. TITLE: SOP FOR CLEANING OF MANUFACTURING VESSEL Page : 01-02 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/59 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.…….………. To lay down a Procedure for Cleaning of Manufacturing Vessel (Topical Section). Q/C Manager. Production Manager/Q.A. Manager SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. 5.1 As soon as the manufacturing of the previous product over, disassemble the following parts:a) b) c) d) e) f) All the Teflon scrappers attached to the anchor. All the stainless steel pipe, valves & tridover joints. Flanges, glass and gaskets. Circular silicon rubber gasket connecting the bowl with top roof. All the homogenizer, parts such as stator, rotor & the housing. All the parts of the pump. 5.2 Connect the bottom discharge valve to the draining with the help of PVC pipe used for draining out the washing. 5.3 Bring the top hood downwards. 5.4 Now pass steam for 5 minutes through the steam inlet to melt wax contents. 5.5 Drain out melted waxy contents through the bottom discharge valve. TITLE: SOP FOR CLEANING OF MANUFACTURING VESSEL Page : 02-02 (TOPICAL SECTION) Deptt.: PRODUCTION SOP No.: SPD/59 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.…………... 5.6 Wipe the entire exterior with cotton cloth. 5.7 Raise the hood and clean interior of the hood and the bowl. Sign.…….………. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE 5.8 Introduce 50 Ltrs. D.M. water and bring the hood to the correct position to introduce steam and boil. 5.9 Run 15 minutes to facilitate proper cleaning of the interior Kettle. 5.10 Rinse the interior of compounding vessel with hot tap water and then subsequently with D. M. water to remove all the traces of detergent. It is confirmed by checking the pH of the water. 5.11 Dry the interior and exterior of the compounding vessel with lint free fresh cotton cloth. 5.12 Sanitize the entire interior surface as well as the contra rotary heater with the help of 70% I.P.A. and leave it for drying. 5.13 Reassemble the sets and bring down the hood to its lowest position. After cleaning, the label should stick & mention “READY FOR USE”. TITLE: SOP FOR CLEANING OF BULK TANK (TOPICAL Page : 01-01 Deptt.: PRODUCTION SOP No.: SPD/60 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director SECTION) Sign.…………………….… Sign.………………………. Sign.…………... 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.…….………. To lay down a Procedure for Cleaning of Bulk Tank (Topical Section). Q/C Manager. Production Manager/Q.A. Manager Q/C Manager. KARNAL-132 001 (HR. Water at least thrice to remove the traces of detergent by checking pH. Ltd. 198-A. To lay down a Procedure for Cleaning and Assembling Procedure of Tube Filling Machine (Topical Section). Karnal.M.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Tank used to store bulk until Production Report.2 Clean entire exterior and interior with the help of hot Teepol solution (0.: SPD/61 Effective Date: 15-07-2007 Revision No.……………………….4 Dry the interior and exterior surface with lint free cloth and after drying sanitize with 70% IPA and affix an appropriate cleaning label. Sign.S. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. 5.M.3 Rinse with D.A. 5. Manager Director Sign. Ltd.SARTHAK BIOTECH Pvt.……………………. Production Manager/Q. TITLE: SOP FOR CLEANING AND ASSEMBLING PROCEDURE Page : 01-01 OF TUBE FILLING MACHINE (TOPICAL SECTION) Deptt.………….: PRODUCTION SOP No.A. 5) PROCEDURE : S.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. HSIIDC. 5.……….……. Sector-3. water again. if detergent is present then rinse with D.1%).1 Wipe the wax contents from the tank with a lint free clean cotton cloth..… Sign.. it is cleaned as per the following procedure. Manager . 5. In order to exclude the possibility of cross contamination. Production Chemist Production Manager Q.. 3) ACCOUNTABILITY : Production Manager/Q.1) Isolate the machine from power and remover hopper along with valve housing. Sign.…….A. Ltd. and cap holders are first washed with hot Teepol solution (0.1%) and then with plain hot water. 5. second fold and embossing and clean with hot Teepol solution (0. 5.: SPD/62 Effective Date: 15-07-2007 Revision No. TITLE: SOP FOR POLISHING OF CAPSULES Page : 01-01 Deptt.2) Remove the nozzle and release pin. Now sanitize all the parts coming in contact with product with 70% I.6) Overall. KARNAL-132 001 (HR.…………………….P.………………………. 5.SARTHAK BIOTECH Pvt. 198-A. HSIIDC. 5. Production Chemist Production Manager Q. Manager .7) Now reassemble valve housing nozzle and hopper. Ltd.4) Check the jaws of the first fold. 2) RESPONSIBILITY : Q/C Manager..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt..………. repeat the cleaning process.: PRODUCTION SOP No. 1) PURPOSE : To lay down a Procedure for Polishing of Capsules. 5. 5.… Sign.3) Remove the caps holding tube. Karnal. Sector-3.A. Manager Director Sign.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.5) The hopper valve housing nozzle release pin..1%) and rinse twice with plain hot water and dry with lint free wet cloth. If there is any sign of the presence of cream / ointment. clean the outside of the machine with hot Teepol solution (0. 5) PROCEDURE : It works on the principle of suctions:- 5. Then use plain hot water at least twice to remove the detergent and dried with lint free cloth. Sign.A. place the caps back in the belt and the fix the outlet can suitably.………….1%). 5) PROCEDURE : POLISHING PROCEDURE OF FILLED CAPSULES:- A separate cubicle is allocated in capsule section for this job. HSIIDC.… Sign... Record is maintained in the format. Use clean towel and cotton gloves. 2) Remove powder from powder collection trays.…………………….: SPD/63 Effective Date: 15-07-2007 Revision No. 198-A.A.………….………………………. Wax Melting Vessel (Topical Section). 5) After polishing keep polished capsule in cleaned. Sector-3. 4) Sometimes.………. Manager .S. Ltd. TITLE: SOP FOR CLEANING OF S.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd. moisture and light free air tight containers. liquid paraffin is used for the polishing. WAX MELTING VESSEL Page : 01-01 (TOPICAL SECTION) Deptt.. Q/C Manager. KARNAL-132 001 (HR. 1) Remove filled capsule from hopper / container.S.SARTHAK BIOTECH Pvt. Karnal. Production Chemist Production Manager Q. 6) Separate polishing cloth from polishing chamber and replace it with a fresh polishing cloth.: PRODUCTION SOP No. Production Manager/Q.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 3) Dedust external surface with vacuum cleaner and then clean properly with lint free cloth duster.……. To lay down a Procedure for Cleaning of S. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Manager Director Sign. Sign. Sign.……………………. HSIIDC. Sign. 5. to remove trace of alkali and checked by using pH paper.: PRODUCTION SOP No. 1) PURPOSE : To lay down a Procedure for Polishing of Puches and Dies. fill the tank with hot tap water (60OC) and clean inner surface with the help of nylon cloth brush.1% Teepol solution) and heated to 90 OC. Again fill the tank with (0.. 3) ACCOUNTABILITY : Production Manager/Q.M.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Leave for 20 minutes and drawn off from the mixture and run the tank with plain hot water at least thrice to remove detergent.2 Take 0.5 Finally clean the lid and place it over the tank and label ‘READY FOR USE’ it.3 Rinse tank with plain hot water and repeat the process three times..………. TITLE: SOP FOR FOR POLISHING OF PUNCHES AND DIES Page : 01-02 Deptt. Karnal. 5) PROCEDURE : To prevent from yield variation and assay the melting tank is cleaned as per below direction:- 5. KARNAL-132 001 (HR..A. 2) RESPONSIBILITY : Q/C Manager. Sector-3.SARTHAK BIOTECH Pvt. 5. Manager Director Sign.01% NaOH and rub the inner surface of the tank to remove any trace of wax.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……………………….……. 5. 5. So that wax melts and get mixed with hot water and drains it. Production Chemist Production Manager Q. Again fill the tank up to 90% water of its capacity and steam is passed until the temperature set to 90OC.1 When the oil phase is transferred compounding vessel. 198-A.… Sign.A. water collected.…………. Ltd.4 Clean the interior of the tank with freshly D. Manager . Ltd.: SPD/64 Effective Date: 15-07-2007 Revision No. Motorized polishing machine.: SPD/64 Effective Date: 15-07-2007 Revision No. Dies are polished when:1. Sign.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : A. There is burr or claw on punch tip. Production Chemist Production Manager Q. Punch tip turns black. Ltd. Wear or binding takes place in die-bore...………….……. Die bore turns black 3. 2. TITLE: SOP FOR POLISHING OF PUNCHES AND DIES Page : 02-02 Deptt. HSIIDC. B.………………………. . Sign.SARTHAK BIOTECH Pvt. 2.…………………….………. Sticking continues on embossing. Roughness on the tip is observed. 4. 3. There is ring formation inside die-bore. 4.: PRODUCTION SOP No. Manager Director Sign. Appearance of tablet becomes dull. C. Corrosion is observed inside die-bore. Sector-3. Ltd..… Sign. 198-A. RMP of the machine can be controlled. Punches are polished when:1. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 2. Equipment to be used for polishing:1. Karnal.A. The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. KARNAL-132 001 (HR. inspect the tools carefully using magnifying glass and carry out finger nail test. 2. 3. Manager Director Sign. Felt-bob. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Page : 01-01 SPOONS AND SCOOPS (TOPICAL SECTION) Deptt.……………………. HSIIDC. for polishing the die-bore. Before starting polishing operation. Used for cleaning and polishing of punch-Tip and die-bore. for removing the burr or claw.. Recommended Tools and Compounds:1. Sign. Oil-stone and lapping stick.………. 4. Manager . Silicon paste or luster bar or emery flour.: PRODUCTION SOP No. TITLE: SOP FOR CLEANING OF UTENSILS. D. KARNAL-132 001 (HR. Production Chemist Production Manager Q. Diamond past (3 micron) for removing continuous sticking. for cleaning and polishing of punch tip. 6. Spoons and Scoops (Topical Section). for identifying the damaged surface and finished of the tip. To lay down a Procedure for Cleaning of Utensils.SARTHAK BIOTECH Pvt. Q/C Manager. Nylon brush. 5. for signs of damage of tip. with emery paste.: SPD/65 Effective Date: 15-07-2007 Revision No. SCRAPPER. Magnifying glass. Emery paper 150 grit.………….A. Sector-3. 7. Production Manager/Q.A. (wheel type) for polishing embossed tips.) STANDARD OPERATING PROCEDURE 3.……. 198-A. 8.………………………. for improving the surface finish. for removing corrosion from the tools. Nylon brush. E. Ltd.… Sign. Scrapper. (cup type) with emery paste..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. …….8 Affix ‘READY FOR USE’ label. water (70OC).A..A.A.: SPD/66 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.2 Clean with (70OC) hot DM water.1 After using scrapper and utensils. 5.1%).7 Sanitize with 70% I..…………………….…………. Sign. Q/C Manager. 5. 5. Production Chemist Production Manager Q.… Sign.……………………….M. clean all utensils and remove the wax material. Sector-3.5 Clean with hot DM water thrice to remove traces of detergent. Karnal. 5. 5) PROCEDURE : These are used to transfer bulk form one place to another so there are potentials of cross contamination so it should clean as per the prescribed procedure. To lay down a Procedure for Removal of Bulk from Tube Filling Machine (Topical Section). Ltd. 5.6 Wash with hot fresh D. 5. 5. HSIIDC. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. KARNAL-132 001 (HR. Production Manager/Q.……….) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: PRODUCTION SOP No. 5. Ltd. Manager Director Sign.4 Clean all the area like grooves and sharp angle with tiny Nylon brush to remove the left over. Manager . TITLE: SOP FOR REMOVAL OF BULK FROM TUBE FILLING Page : 01-01 MACHINE (TOPICAL SECTION) Deptt..P. 198-A.3 Clean with hot Teepol solution (0.SARTHAK BIOTECH Pvt. ……….A.A. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. 5.…………. 198-A.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Manager . Sector-3. Production Manager/Q. Ltd.……………………….…….… Sign. KARNAL-132 001 (HR.: SPD/67 Effective Date: 15-07-2007 Revision No.1 Finished material leaked from side and back side of the valve connected in a S.2 This amount is converted into equivalent number of filled tubes utilized for reconciliation. Sign. TITLE: SOP FOR IN-PROCESS CONTOL IN MANUFACTURING Page : 01-01 (TOPICAL SECTION) Deptt. Manager Director Sign. container and labeled as “Container For Rejection”. To lay down a Procedure for In-process Control in Manufacturing (Topical Section) Q/C Manager.. Ltd.…………………….: PRODUCTION SOP No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5) PROCEDURE : During filling material is leaked from the side nozzle adjacent to the valve. Production Chemist Production Manager Q.SARTHAK BIOTECH Pvt. 5..S. Karnal.3 Such leaked semisolid is disposed off after filling operation for each batch. HSIIDC. Discarding of leaked material:- 5.. Q/C. by checking the weight of empty tubes and gross weight.A. 5. Karnal.: SPD/68 Effective Date: 15-07-2007 Revision No.A.. 5. To lay down a Procedure for House Keeping in Topical Section.P.P. i. 5. KARNAL-132 001 (HR..…………. HSIIDC. to prevent pinhole developments on the embossed letter. 5. Production Chemist Production Manager Q. coding of the filled Aluminum collapsible tube or plastic tube take and the embossing of Batch number and manufacturing date at the interval of 30 minutes.………. should check the crimping.……………………….2 Hopper is filled only half of the capacity. Production Manager/Q.: PRODUCTION SOP No.. Q/C.1 pH Checking. Q/C Manager.5 At every interval of 30 minutes following measurements are recorded. 5.3 While the tube filling operation is on.4 I. Manager . TITLE: SOP FOR HOUSE KEEPING IN TOPICAL SECTION Page : 01-01 Deptt.SARTHAK BIOTECH Pvt.. Minimum weight and maximum weight.…………………….. Ltd. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Sector-3. Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.……. Ltd. Manager Director Sign. weight of net filled quantity per tube is checked at the interval of 30 minutes by the I. ii.… Sign. 198-A.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Tare weight of tube. Quality for embossing is controlled by adjusting pressure excreted by jaws. spatulas.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. though in continuous use are nevertheless be adequately covered with polythene sheets and kept at a pre-designated place. Ensure proper line clearance before starting. scoops. Ltd. 198-A. Manager Director Sign. The operator wore rubber / plastic/ disposable hand gloves. vi. 1) PURPOSE : To lay down a Procedure for Installation of New Punch Set. iii. 3) ACCOUNTABILITY : Production Manager/Q.. 2) RESPONSIBILITY : Q/C Manager.SARTHAK BIOTECH Pvt. ii. All packing materials are received as per packing.: SPD/69 Effective Date: 15-07-2007 Revision No. Sector-3. to clear any spoilage from floor. At suitable interval the floor is cleaned.… Sign. Manager ... Ltd. TITLE: SOP FOR INSTALLATION OF NEW PUNCH SET Page : 01-02 Deptt.: PRODUCTION SOP No.e.A.……. All employees wore neat & clean uniform. The accessories i.…………. Sign. vii. facemask.………………………. KARNAL-132 001 (HR. iv. i.A. footwear & Surgeon’s cap and mouth cover.……………………. HSIIDC. Karnal. v.………. Equipment and accessories not in use are properly covered and labeled. Sign.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Production Chemist Production Manager Q. and as per required. Sector-3. Ltd.2 Wipe all punches and dies with cotton rags to remove any traces of grease. 5. Sign..: PRODUCTION SOP No. 5.……. KARNAL-132 001 (HR.. 5. clean the tray of diesel to ensure the absence of any particulate matter from diesel and punch sets.……………………….SARTHAK BIOTECH Pvt.6 Issue the required no. of punches and dies for setting on compression machine and keep remaining extra sets in respective box after oiling.5 Check any 2 dies by dipping in fresh clear diesel to confirm the absence any particulate matter. Manager Director Sign. 5. HSIIDC. Sign.: SPD/69 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……………………. immerse all new punches and dies (including extra sets) into sufficient quantity of diesel for 30 minutes.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 Before setting of compression machine.…………. Karnal. TITLE: SOP FOR INSTALLATION OF NEW PUNCH SET Page : 02-02 Deptt.4 Immerse all punches and dies into fresh diesel (sufficient) for 10 minutes and then wipe with cotton rags.3 Discard diesel after use. 5. FOR USED PUNCHES AND DIES:a) Before fixing on machine : 1) Wipe required no. 5. of punches and dies with duster dipped in clear diesel.. 198-A.… Sign. Ltd.A. .………. Production Chemist Production Manager Q. 198-A.…………. 2) Wipe all punches.: SPD/70 Effective Date: 15-07-2007 Revision No. after inspecting them in absence of previous material and any damage to punch set.… Sign. Ltd. Production Chemist Production Manager Q. Production Manager/Q.……………………. 3) Apply a thin layer of oil (SAE 40) on punch tip. 3) After visual inspection of punch tip and die bore. start setting as per SOP. TITLE: SOP FOR IN-PROCESS PACKING (TOPICAL SECTION) Page : 01-01 Deptt. 4) Keep punches and dies in respective punch boxes in spare part room. KARNAL-132 001 (HR. Sign. To lay down a Procedure for In-process Packing (Topical Section)..A.: PRODUCTION SOP No. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. After removing from machine: 1) Immerse all punches and dies into sufficient diesel for minimum 30 minute.………. HSIIDC.A. Sector-3.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Q/C Manager.) STANDARD OPERATING PROCEDURE b) 2) Clean the die bore with cotton rags. Manager Director Sign. Manager .……………………….…….SARTHAK BIOTECH Pvt.. body head & die bore. dies & dies bore with cotton rags and make respective entries in punch stock record. Ltd.………. Sign.4 Present of filled tubes in the carton .A.2 Correctness of carton. Q/C Manager. To lay down a Procedure for Line Clearance (Topical Section).. 5. During packing operation. 5.………………………. 5. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. 5.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR.A.…………………….5 Correct no. Production Chemist Production Manager Q. TITLE: SOP FOR LINE CLEARANCE (TOPICAL SECTION) Page : 01-01 Deptt.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: PRODUCTION SOP No. HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: SPD/71 Effective Date: 15-07-2007 Revision No.1 Correctness of Batch No.. 5. strength and quantity along with information regarding batch no. of outer box per shipper. Manager . date of expiry and price etc. 5) PROCEDURE : It gives the product identity.…….…………. 5. and shipper.3 Correctness of all embossed text. 5.. Manager Director Sign.… Sign.7 Correct weight of filled tube. following in process check is carried out at every 30 minutes. 198-A. Ltd. date of manufacture. Sector-3.. Karnal. Production Manager/Q.6 Use of correct colour of the ink. 5.SARTHAK BIOTECH Pvt. Sign.8 Line clearance is recorded on a suitable FORMAT.………………………. shipper.4 Packing equipment is properly cleaned. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign.. 5. overprinted carton. TITLE: SOP FOR CLEANING OF S.5 If packing machine is not used for one week. Ltd. 5. 198-A.………….A. Manager .A. HSIIDC. KARNAL-132 001 (HR. Q/C Manager.A. Ltd..6 If above condition is OK. Manager. WATER VESSEL Page : 01-01 (TOPICAL SECTION) Deptt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Manager.: PRODUCTION SOP No. Karnal.e.………. until line clearance is endorsed by Q. 5.……………………. Water Vessel (Topical Section). It means line is clear and signed by concerned Q.… Sign. 5..) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. To lay down a Procedure for Cleaning of S.7 Packing should not commence.…….2 On line rejection are removed. Sector-3.S. Production Chemist Production Manager Q. Manager Director Sign.A.S.: SPD/72 Effective Date: 15-07-2007 Revision No. 5. it should be re-inspected and if required re-cleaned.3 Any spoilage is moped & cleaned.1 The packing line should be free from filled product and packing material of previous batch i. 5. rejected tubes. 5. Production Manager/Q. 01% NaOH & rub the inner surface of the tank to remove any trace of wax.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.………. Q/C Manager. To lay down a Procedure for In-process Fill Weight Dentermination. Again fill the tank with (0.4 Clean the interior of the tank with freshly D. water collected.2 Take 0..5 Finally clean the lid and place it over the tank and label it.…………. Sign. 5) PROCEDURE : To prevent from yield variation and assay the water tank is cleaned as per below direction:- 5. fill the tank with hot tap water (60OC) and clean inner surface with the help of nylon cloth brush. Production Chemist Production Manager Q.) STANDARD OPERATING PROCEDURE 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.M.1 When the water phase is transferred to compounding vessel. Manager Director Sign. Sector-3. Leave for 20 minutes and drawn off from the mixture & run the tank with plain hot water at least thrice to remove detergent.: PRODUCTION SOP No. 5.… Sign.. HSIIDC.A.: SPD/73 Effective Date: 15-07-2007 Revision No. Again fill the tank up to 90% water of its capacity and steam is passed till the temperature set to 90OC drain it. KARNAL-132 001 (HR. 5.……………………….A.SARTHAK BIOTECH Pvt.……………………. TITLE: SOP FOR IN – PROCESS FILL WEIGHT Page : 01-01 DETERMINATION Deptt. Production Manager/Q. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. to remove trace of alkali and checked by using pH paper.3 Rinse tank with plain hot water and repeat the process three times. 5. Ltd. 198-A.. Ltd. 5.1% Teepol solution) and heated to 90OC.……. Manager . Karnal. re-inspected the filled tube. Compare net filled weight.. Fill and record the individual gross. During filling: 1.…………. 3. The average net weight is not less than the labeled amount and the net weight of any single container is between 91% to 109% for 5gm to 50gm tubes and between 95. Pre weight and marked two individual tubes. Minimum and Maximum limits for fill weight is established & recorded on the in process sheet.A. Sector-3.. 2. Fill weight is checked at the start of filling and at the interval of 30 minutes from each filling head..) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : A) B) C) The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd. Sign.…….…………………….A. Finished package contain filled tube. Production Manager/Q. Manager . Ltd. 2.………………………. The filled tube must be cleaned. During filling operation: 1.5% for 50 gm to 100gm. Q/C Manager. Karnal. TITLE: SOP FOR LABELING & PACKING OF ORAL LIQUID Page : 01-01 Deptt. obtained net weight to determine average fill weight.: PRODUCTION SOP No. Production Chemist Production Manager Q. After filling operations: 1. 3.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign.: SPD/74 Effective Date: 15-07-2007 Revision No. Manager Director Sign. 198-A.……….SARTHAK BIOTECH Pvt. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. 2. To lay down a Procedure for Labeling and Packing of Oral Liquid. KARNAL-132 001 (HR. HSIIDC. In case of unacceptable fill weight. tare & net weights.5% to 104. . KARNAL-132 001 (HR. check the packing materials. SS Page : 01-01 CONTAINERS. 5.2 Check the overprinting details i. 198-A. Sign. S. and tick mark after checking of correctness of overprinting matter enter these data in logbook & get it verified.: SPD/75 Effective Date: 15-07-2007 Revision No.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……….… Sign.1 Before issuance.……. Production Chemist Production Manager Q.: PRODUCTION SOP No.P. TITLE: SOP FOR CLEANING OF GENERAL UTENSILS. Containers. Karnal. Date.e. sign. To lay down a Procedure for Cleaning of General Utensils. Manager . 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Manager Director Sign. 5. Date and M. 5. on them and get certified from QA. Batch No.……………………. Mfg. Sector-3..R.A.5 Filled quantity for CB box to be checked every 1-hour interval.……………………….…………. Exp. 5. etc. Q/C Manager. 5.SARTHAK BIOTECH Pvt. Deptt..S. HSIIDC. Ltd.A.3 Paste samples of overprinted label and carton.4 Packing quantity and filled quantity to be checked every 1-hour interval. Ltd. Production Manager/Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. .4. The General Utensils like S.……….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5. Q/C Manager.: SPD/76 Effective Date: 15-07-2007 Revision No. Container. 5.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt..S.: PRODUCTION SOP No.A. Karnal.1. Manager Director Sign.S. TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 01-04 (TABLET.…………………….A. Moped with dry clean cloth.…………. Manager . S. Production Chemist Production Manager Q. 5. S. KARNAL-132 001 (HR. Ltd.S. CAPSULE & LIQUID ORALS) Deptt.SARTHAK BIOTECH Pvt. Scoops.…….2. Ltd. Production Manager/Q. To lay down a Procedure for Cleaning of Manufacturing Area (Tablet. Capsule and Orals Liquid). 5.………………………. are washed with water. Trays etc.… Sign. Finally washed with DM Water and are checked from the Q.3. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Sign. Wash with liquid soap or detergent with gentle rubbing then again wash with fresh water until the detergent foam is completely washed out. 198-A.C. HSIIDC. Sector-3.. Sign. Lab. Production Chemist Production Manager Q. coating & capsule filling etc.9 The remnant of the moping solution is put in the mainhole where the wash water effluent from hormone/ ß-Lactum section is coming.) STANDARD OPERATING PROCEDURE 4) SCOPE : 5) PROCEDURE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.…….3 Similarly all the hoopers & extensors machines. 5. windows and portion are de-dusted once in the evening after the days work is over.: PRODUCTION SOP No. are then moped by using Non Ionic soap:a) Preparation of soap solution. 5. doors.… Sign. 5..6 The floor of working area is de-dusted with broom slice and moped with detergent solution just before the start of day’s work. Sector-3. Manager Director Sign. tableting. Sign.………………………. 5. b) Formula: c) Process water - d) Non Ionic soap - 20 gm 10 Liters 5.. KARNAL-132 001 (HR.1 Doors.…………. table hoops etc. Karnal. HSIIDC.………..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.8 The moping dish should be strained in the bucket and then dried. Sign. 5.2 Floors of mining blending.……………………. 198-A. 5. The dust is collected in a closed dustbin.A. Ltd.5 The entire area including windows. tables and other furniture and fixtures are de-dusted and the resulting dust is collected in the same dustbin. 5. CAPSULE & LIQUID ORALS) Deptt.4 The entire collected dust is dumped in the pit meant for disposal of sensitizing material 5.: SPD/76 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt. TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 02-04 (TABLET. Ltd. .7 The machine interiors are not required to be wet moped. areas are de-dusted in the evening after the days work and the dusts are collected in the dust bin. Sector-3. Production Chemist Production Manager Q.A. 5. HSIIDC.………………………. KARNAL-132 001 (HR. CAPSULE & DRY SYRUP MANUFACTURING SECTION S. Manager Director Sign.SARTHAK BIOTECH Pvt. Sign.…………. 5.……….… Sign. doors are moped daily.: SPD/76 Effective Date: 15-07-2007 Revision No.0 Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. The record is maintained as per following format: CLEANING RECORD FOR TABLET. 6..) STANDARD OPERATING PROCEDURE 5.. No.……. Ltd. 5.13 All m/c & parts are cleaned after completion of work.……………………. 198-A.10 The walls of the rooms are painted once a year using alkaline/neutral epoxy bound distemper.11 In liquid oral section window pans. Area Floors Platform Walls Doors/ Windows Ceilings Exhaust fan Ceiling Fan Tube lights Done by Chec ked by . CAPSULE & LIQUID ORALS) Deptt.: PRODUCTION SOP No.12 Floors are moped daily in evening after completion of work. TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 03-04 (TABLET. Walls Twice a week . Platform & Tables Once a day or after completion of work. 3.……………………….……. HSIIDC.1% solution of detergent with moping Daily Monthly Vaccum of Vaccum of Cleaning moping Cleaning moping with 0... No. mop with disinfectant Twice a week Vacuum cleaning Cleaning with 0. 7.1% detergent solution Weekly Once a day Weekly Weekly TITLE: SOP FOR CLEANING OF MANUFACTURING AREA Page : 04-04 (TABLET.…..: PRODUCTION SOP No. Sign. KARNAL-132 001 (HR.1% solution detergent solution Vaccum of Cleaning moping with 0. damp mop with disinfectant Twice a day Cleaning of Cleaning with surface with scrubber and scrubber & hose of water water. Ltd..A.1% detergent with 0.SARTHAK BIOTECH Pvt.: SPD/76 Effective Date: 15-07-2007 Revision No.……………………. Manager Director Sign.………. Sign. CAPSULE & LIQUID ORALS) Deptt.… Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. Production Chemist Production Manager Q. Area Name Cleaning Schedule 1. 198-A.………. Floors Twice a day 2.) STANDARD OPERATING PROCEDURE Date Washing using scrubber and hose of water.0 Cleaning Schedule: S. Production Chemist Production Manager Q.. Ltd.……………………. Doors / Windows Daily 5. Karnal. Ceilings Monthly 6.SARTHAK BIOTECH Pvt.A. Containers. TANKS & STIRRER Deptt.S. Pressure Vessels. : To lay down a Procedure for Cleaning of S.………………………. Ceiling Fan Weekly 8. Ltd. CONTAINERS.: SPD/77 Effective Date: 15-07-2007 Revision No. Manager 4) SCOPE The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. HSIIDC. Manager Director Sign.. .… Sign. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Tube Lights Weekly TITLE: SOP FOR CLEANING OF S. Tanks and Stirrer.A.) STANDARD OPERATING PROCEDURE 4.S. Q/C Manager.: PRODUCTION SOP No.S. Sector-3.…………. Sign. KARNAL-132 001 (HR.. Sign.……….……. S. 198-A.S. S. Exhaust Fan Weekly 7.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. PRESSURE Page : 01-01 VESSELS. Sign. 1) PURPOSE : To lay down a Procedure for Cleaning of Conveyor Belt.. 5. and drain off completely.) STANDARD OPERATING PROCEDURE 5) PROCEDURE : 5..… Sign. Water to remove all traces of the detergent. Fix the lid properly. Manager Director Sign.…….4 Wash with D.A. 5. Manager regularly. Water.. 5.: SPD/78 Effective Date: 15-07-2007 Revision No. HSIIDC.SARTHAK BIOTECH Pvt.6 Washing to be monitor by Q..A. Production Chemist Production Manager Q. Wash the lid similarly.7 Affix a status label and date. 5. 198-A.M. 5) PROCEDURE : . Sector-3. containers with its lid. 5. 3) ACCOUNTABILITY : Production Manager/Q.……….………………………. TITLE: SOP FOR CLEANING OF CONVEYOR BELT Page : 01-01 Deptt. Sign. Ltd. Karnal. Scrub with 0. membrane filter holder and pressure vessels to the washing area. KARNAL-132 001 (HR. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 Transfer the tank.….……….2 Keep aside the lid and other part of vessels at sufficient height..…………………….1% Teepol solution using nylon ball.C.5 Rinse with filtered Distilled water.3 Flush the tank and vessel with D. Ltd.M. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 2) RESPONSIBILITY : Q/C Manager.: PRODUCTION SOP No. on the top to facilitate cleaning. Again moping the surfaces repeatedly.A. Q/C Manager. using clean dry cloth. At the end of the shift the equipment should be cleaned. Sector-3.: PRODUCTION SOP No. 5.…. Check oil in the gearbox and wipe the excess of oil using cotton waste. 5. 5. Manager Director Sign. Ltd. using clean cloth. 5. Check electrical terminals for insulation and soundness of terminal connections.. if required. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Bottle Filling Machine. Sign.6. Remove any stains or pieces of gum tape sticked on the surfaces. Sign. using clean cloth dipped in water.5% solution of Teepol. Wipe dry the surfaces using clean dry cloth.2.………………………..: SPD/79 Effective Date: 15-07-2007 Revision No. 198-A. 5) PROCEDURE : .5. Karnal.A.3.……………………. 0.4.………. Ltd. Switch on the machine and bring the lower portion of conveyor belt.………. Wipe the surfaces of conveyor belt and table.1. 5.SARTHAK BIOTECH Pvt. Production Chemist Production Manager Q.7. Moping the surfaces of tabletop and conveyor belt using.… Sign. Use vacuum cleaner. HSIIDC... Check soundness of electrical switches and its contacts. Ensure complete removal of detergent.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. Put status label ‘CLEANED’ and date.) STANDARD OPERATING PROCEDURE 5. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.……. TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 01-03 FILLING MACHINE Deptt. KARNAL-132 001 (HR. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE MACHINE NAME Bottle Filling Machine M/C No.: _____________ The entire Machine Operation & Cleaning procedure is divided in three stages. i) Pre-operative Cleaning & Setting. ii) Operation iii) Post Operative Cleaning and equipment preparation. STAGE – I a) The exterior of the machine is cleaned with dry cloth b) The electrical connections are restored by pulling the plug top into the socket. c) The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No. etc. is put on the top cover of the machine. d) The filling syringe inlet pipe fitted with the filling machine is cleaned by D.M. water. e) Empty glass bottle kept near the filling machine. TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 02-03 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/79 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. STAGE – II a) The Bottle Filling Machine is switched on and run for few seconds to observe whether it is running normally or not. b) If any abnormal sound is heard the machine is referred to maintenance dept. for rectification. c) In other case, the machine is started and the liquid is out from the syringe and the volume set as required. d) The process is continued until the entire liquid is filled. SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE e) In case of Product or composition change, the entire m/c is washed and wash water analysis is done by Q.C.D. render the m/c ready for further use. STAGE – III a) After the day’s operation or Production change or change of composition all the contact parts like inlet and outlet pipe, syringe and nozzle etc. are thoroughly cleaned and wash water is sent to Q.C.D. for testing. b) Once the wash water analysis is cleared by Q.C.D. The contact parts and other parts are moped and dried. c) The connection is then cut off by taking out the plug top from the socket. d) A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use. A logbook is kept for each machine of operation in the format given in annexure 1 TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 03-03 FILLING MACHINE Deptt.: PRODUCTION SOP No.: SPD/79 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. ANNEXURE-I LOG BOOK M/C: BOTTLE FILLING MACHINE Date Start Time Finish Time Total hrs. of running Machine No. Breakdown Start End Down Time hrs. Page No.____ Product, Batch No., B. Size, Mfd. & Exp. Operator & Checked By SARTHAK BIOTECH Pvt. Ltd. 198-A, Sector-3, HSIIDC, KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 01-03 WASHING MACHINE Deptt.: PRODUCTION SOP No.: SPD/80 Effective Date: 15-07-2007 Revision No.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.A. Manager Director Sign.…………………….… Sign.………………………. Sign.………...…... Sign.…….………. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Bottle Washing Machine. Q/C Manager. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.A. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd., Karnal. 5) PROCEDURE : A. STAGE – I a) The exterior of the machine is cleaned with dry cloth b) The electrical connections are restored by pulling the plug top into the socket.3 Post Operative Cleaning and equipment preparation.……. Sector-3. KARNAL-132 001 (HR. TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 02-03 WASHING MACHINE Deptt. HSIIDC.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. M.… Sign.2 Operation 5. M. c) In other case the machine is started and the bottle wash with the help of brush.………. for rectification.………………………. b) If any abnormal sound is heard the machine is referred to maintenance dept. :_____________ The entire Machine Operation & Cleaning is divided in three stages.: SPD/80 Effective Date: 15-07-2007 Revision No. Sign.…. Water and then these bottle washed with the jet.……………………. etc.SARTHAK BIOTECH Pvt. c) The “Machine Ready for use” sticker is removed and sticker/tag showing product Batch No...) STANDARD OPERATING PROCEDURE MACHINE NAME: Jet Bottle Washing Machine M/C No. Water and check the pressure of the water flow.………. is put on the top cover of the machine. d) Connect the jet with D.: PRODUCTION SOP No. 5.1 Pre-operative Cleaning & Setting. 5. e) The process is continued until all the bottles are washed. Manager Director Sign. Ltd.. STAGE – II a) The Bottle Washing Machine is switched on and run for few seconds to observe whether it is running normally or not. d) The brushed bottle is dipped into fresh D.. . Production Chemist Production Manager Q. Sign. 198-A. KARNAL-132 001 (HR.: PRODUCTION SOP No. & Exp. Sign..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign. Manager Director Sign.A.……….: SPD/80 Effective Date: 15-07-2007 Revision No. Mfd.……. HSIIDC.) STANDARD OPERATING PROCEDURE f) In case of Size or product change. Size. The contact parts and other parts are moped and dried.……….D..SARTHAK BIOTECH Pvt._ Operator & Checked By . Sector-3. Batch No. A logbook is kept for each machine of operation in the format given in annexure 1 TITLE: SOP FOR OPERATION & CLEANING OF BOTTLE Page : 03-03 WASHING MACHINE Deptt. of running Breakdown Start End Machine No. Ltd. B. are thoroughly cleaned by detergent potable water and finally by D. c) The connection is then cut off by taking out the plug top from the socket. the brush is changed. STAGE – III a) After the day’s operation or production change or change of composition all the contact parts like brush and containers etc.. Down Time hrs.. Sign. d) A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use. Page No.…. b) Once the wash water analysis is cleared by Q..C. ANNEXURE-I LOG BOOK M/C: JET BOTTLE WASHING MACHINE Date Start Time Finish Time Total hrs. Product. Water. 198-A.……………………….……………………. Production Chemist Production Manager Q. M. : PRODUCTION SOP No.…….…. HSIIDC.…………………….… Sign. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Colloidal Machine.. Karnal. Sign.……………………….. 198-A.A.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 01-03 MACHINE Deptt. Manager Director Sign.………..……….. Ltd. Sign. 5) PROCEDURE : MACHINE NAME: Colloidal Mill M/C No. .: SPD/81 Effective Date: 15-07-2007 Revision No. Production Chemist Production Manager Q. Q/C Manager. Sector-3. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. KARNAL-132 001 (HR..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: _______________ The entire Machine Operation & Cleaning is divided in three stages. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.SARTHAK BIOTECH Pvt. Ltd.A. d. TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 02-03 MACHINE Deptt.) STANDARD OPERATING PROCEDURE i) Pre-operative Cleaning & Setting. The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No.………………………. c. KARNAL-132 001 (HR. STAGE – II a.: SPD/81 Effective Date: 15-07-2007 Revision No.A.…………………….………. HSIIDC.SARTHAK BIOTECH Pvt..………. The process is continued until the entire liquid is colloid..: PRODUCTION SOP No. If further colloid of the same batch is required it is continued. e. for rectification. Ltd. b.…….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. is put on the top cover of the machine. Manager Director Sign. container is kept below the outlet of the M/c.S. 198-A.. In other case the machine is started and the liquid is out on the hopper slowly and gradually. Sign. If any abnormal sound is heard the machine is referred to maintenance dept. Production Chemist Production Manager Q. The colloidal liquid is collected in the S.. e. The container containing the material is brought near the machine. The electrical connections are restored by pulling the plug top into the socket.S. Sector-3. d. ii) Operation iii) Post Operative Cleaning and equipment preparation. c. container. f. etc. STAGE – I a. Sign. The exterior of the machine is cleaned with dry cloth b.… Sign.…. A plastic/S. . The colloidal mill is switched on and run for few seconds to observe whether if is running normally or not. Operator & Checked By . Size.____ Down Time hrs.……. Sector-3. B. Sign. Mfd. Breakdown Start End Page No.C. of running Machine No. Production Chemist Production Manager Q.SARTHAK BIOTECH Pvt.) STANDARD OPERATING PROCEDURE g. for testing. Ltd.. Sign.A. & Exp.M. KARNAL-132 001 (HR. After the day’s operation or Production change or change of composition all the contact parts like hopper. A logbook is kept for each machine of operation in the format given in annexure 1 TITLE: SOP FOR OPERATION & CLEANING OF COLLOIDAL Page : 03-03 MACHINE Deptt.…. HSIIDC..D.……………………. d. In case of batch changes. water.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. STAGE – III a.……………………….D.……….C. 198-A. ANNEXURE-I LOG BOOK M/C: COLLOIDAL MILL Date Start Time Finish Time Total hrs.: SPD/81 Effective Date: 15-07-2007 Revision No.: PRODUCTION SOP No. Batch No. Once the wash water analysis is cleared by Q. Product. A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use. The connection is then cut off by taking out the plug top from the socket..………..… Sign. the contact parts are cleaned by water and then D. b. c. The contact parts and other parts are moped and dried.. Manager Director Sign. pipe and grinding parts are thoroughly cleaned and wash water is sent to Q. ………………………. Sign.……….: SPD/82 Effective Date: 15-07-2007 Revision No..: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 01-03 STIRRER Deptt. Manager Director Sign.1 Pre-operative Cleaning & Setting. 6. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.…….………..A... Q/C Manager. HSIIDC. Production Chemist Production Manager Q.……………………. 198-A. 5) PROCEDURE : MACHINE NAME: High Speed Stirrer M/C No.… Sign. Sign. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.…. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of High Speed Stirrer.SARTHAK BIOTECH Pvt. Ltd. Sector-3. Karnal. Ltd.2 Operation .A.. 6. :___________ The entire Machine Operation & Cleaning is divided in three stages. KARNAL-132 001 (HR. . Drum. the contact parts are cleaned with water.……….A.C. Drum 1000 or 500 Lts. The electrical connections are restored by pulling the plug top into the socket.: PRODUCTION SOP No. showing product Batch No. Ltd. etc.………………………. The “MACHINE READY FOR USE” sticker is removed and sticker/tag. Manager Director Sign..D. The S.SARTHAK BIOTECH Pvt. If any abnormal sound is heard. c..….……………………. Sign. b. for rectification.……. Sign.) STANDARD OPERATING PROCEDURE 6. In case of Product or composition change. d.………. KARNAL-132 001 (HR. f. Production Chemist Production Manager Q.S. The exterior of the machine is cleaned with dry cloth b. the entire machine is washed and wash water analysis is to be done to by Q. e. STAGE – I a. In other case. Sector-3. . The High Speed Stirrer is switched on and run for few seconds to observe whether it is running normally or not. the machine is started slow check the machine. In case of batch changes.S. render the machine ready for further use. The stirring continue until the mass mixed properly.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 02-03 STIRRER Deptt. fitted with stirrer. d.: SPD/82 Effective Date: 15-07-2007 Revision No. the machine is referred to maintenance dept.… Sign. c..3 Post Operative Cleaning and equipment preparation. HSIIDC. STAGE – II a. is put on the top cover of the machine. 198-A. Stirring rod fitted with stirrer and solution kept into S. B. Production Chemist Production Manager Q. Sector-3.A..……. The connection is then cut off by taking out the plug top from the socket.M water and wash water is sent to Q.….) STANDARD OPERATING PROCEDURE STAGE – III a. & Exp. cover. 198-A. After the day’s operation or Production change or change of composition all the contact parts like mixing blade & shaft are thoroughly cleaned and washed.………. Sign. Final washing to be done by D. TITLE: SOP FOR OPERATION & CLEANING OF HIGH SPEED Page : 03-03 STIRRER Deptt.D.: PRODUCTION SOP No..……………………..SARTHAK BIOTECH Pvt. A logbook is kept for each machine of operation in the format given in annexure 1 ANNEXURE-I LOG BOOK M/C: HIGH SPEED STIRRER Date Start Time Finish Time Total hrs.… Sign.. for testing.………………………. A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use. Ltd. The Mass Mixer surface (inner & outer). Operator & Checked By .____ Down Time hrs. HSIIDC. Batch No. Manager Director Sign. are moped and dried.C. blade shaft etc. KARNAL-132 001 (HR. Mfd. Size. Product. of running Machine No. Once the wash water analysis is cleared by Q. d.………. Breakdown Start End Page No..: SPD/82 Effective Date: 15-07-2007 Revision No. Sign.C. c.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. b.D. . Q/C Manager.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR.. Sector-3. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. HSIIDC. Karnal. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Filter Press.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 01-03 PRESS Deptt. Sign.….: PRODUCTION SOP No. Manager Director Sign.…………………….A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.………. 198-A. :_______________ The entire Machine Operation & Cleaning is divided in three stages.………………………. Ltd. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.1 Pre-operative Cleaning & Setting. 5) PROCEDURE : MACHINE NAME: Filter Press M/C No.A. 6.. .: SPD/83 Effective Date: 15-07-2007 Revision No. Production Chemist Production Manager Q.………..… Sign. Ltd. Sign.…….. Sector-3.3 Post Operative Cleaning and equipment preparation.… Sign. d) The filter liquid is contained in to S.) STANDARD OPERATING PROCEDURE 6. c) In other case the machine is started and the liquid is out throw out let pipe slowly and gradually.………. f) If further filtration of the same batch is required it’s continued.2 Operation 6. tank..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.S. Sign. f) The container containing the filter liquid brought near the machine. Production Chemist Production Manager Q. c) The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No.………………………. for rectification. STAGE – I a) The exterior of the machine is cleaned with dry cloth b) The electrical connections are restored by pulling the plug top into the socket.. b) If any abnormal sound is heard the machine is referred to maintenance dept.…….………. is put on the top cover of the machine.. KARNAL-132 001 (HR.S. e) The filter liquid is contained in to S. d) The inlet pipe is connected with filtering liquid and outlet pipe with reservoir tank. . Manager Director Sign.….. Sign.……………………. STAGE – II a) The Filter Press is switched on and run for few seconds to observe whether if is running normally or not. e) The process is continued until the entire liquid filter. tank. 198-A. Ltd.A. HSIIDC.SARTHAK BIOTECH Pvt. TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 02-03 PRESS Deptt. etc.: SPD/83 Effective Date: 15-07-2007 Revision No.: PRODUCTION SOP No. Sign. KARNAL-132 001 (HR.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Size.: SPD/83 Effective Date: 15-07-2007 Revision No. A logbook is kept for each machine of operation in the format given in annexure 1 ANNEXURE-I LOG BOOK Machine Name: Filter Press Date Start Time Finish Time Machine No.….C.: PRODUCTION SOP No.D. 198-A. Page No.… Sign. d) A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.……………………. Batch No. of running Breakdown Start End Down Time hrs. c) The connection is then cut off by taking out the plug top from the socket. & Exp..C. are thoroughly cleaned and wash water is sent to Q.. Operator & Checked By . Sign.D.. __________ Total hrs. the contact parts are cleaned by D. HSIIDC. Ltd.C. Sector-3.………. render the machine ready for the use. B. pipe and filter assembly etc. b) Once the wash water analysis is cleared by Q. The contact parts and other parts are moped and dried.SARTHAK BIOTECH Pvt.…….D.………. Mfd. for testing.____ Product..M water and wash water analysis is to be done by Q.) STANDARD OPERATING PROCEDURE g) In case of batch changes. Manager Director Sign. STAGE – III a) After the day’s operation or Production change or change of composition all the contact parts like filter pads. TITLE: SOP FOR OPERATION & CLEANING OF FILTER Page : 03-03 PRESS Deptt.……………………….. Production Chemist Production Manager Q. . Sign.. Production Chemist Production Manager Q.: SPD/84 Effective Date: 15-07-2007 Revision No.A. 5) PROCEDURE : MACHINE NAME : To lay down a Procedure for Operation and Cleaning of P.2 Operation .……….… Sign. Ltd.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. Cap Sealing Machine. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.A. HSIIDC. Q/C Manager. Manager Director Sign.. Ltd.…….……….) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 01-03 SEALING MACHINE Deptt. Sector-3.. KARNAL-132 001 (HR. Cap Sealing Machine M/C No. :____________ The entire Machine Operation & Cleaning is divided in three stages.….……………………….SARTHAK BIOTECH Pvt.1 Pre-operative Cleaning & Setting. P. 198-A. Sign. 6. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.…………………….P. P.: PRODUCTION SOP No. 6. Karnal. SARTHAK BIOTECH Pvt. Sign. b) If any abnormal sound is heard the machine is referred to maintenance dept.…………………….. Sector-3. Caps. KARNAL-132 001 (HR. e) The machine shifted near the filling machine for easy handling of the bottle.) STANDARD OPERATING PROCEDURE 6.………. HSIIDC.…....……. e) The process is continued until all the bottles are sealed. P. Sign. Manager Director Sign. is put on the top cover of the machine. c) In other case the machine is started and check the sealing and threading of the P.……….: PRODUCTION SOP No.A. Production Chemist Production Manager Q.………………………. etc.: SPD/84 Effective Date: 15-07-2007 Revision No. STAGE – I a) The exterior of the machine is cleaned with dry cloth b) The electrical connections are restored by pulling the plug top into the socket.… Sign. . Ltd. STAGE – II a) The P. for rectification. set the sealing and threading roller.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. c) The “MACHINE READY FOR USE” sticker is removed and sticker/tag showing product Batch No.Cap sealing Machine is switched on and run for few seconds to observe whether it is running normally or not. d) Bottle guides to adjust sealing machine according to the size of the bottle. d) If the seal is abnormal.3 Post Operative Cleaning and equipment preparation. 198-A. TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 02-03 SEALING MACHINE Deptt. P. Batch No. Breakdown Start End Down Time hrs. Operator & Checked By .____ Product. are thoroughly cleaned with water and moped with dry cloth. Sign.: SPD/84 Effective Date: 15-07-2007 Revision No. Manager Director Sign. Page No. 198-A.. KARNAL-132 001 (HR. Size. Ltd. HSIIDC. B. Mfd.… Sign. Production Chemist Production Manager Q...………. Sign.. of running Machine No. c) A sticker stating “MACHINE READY FOR USE” is put on the machine to render it ready for use.: PRODUCTION SOP No.……. TITLE: SOP FOR OPERATION & CLEANING OF PP CAP Page : 03-03 SEALING MACHINE Deptt.) STANDARD OPERATING PROCEDURE STAGE – III a) After the day’s operation or Production change or change of composition all the contact parts like rubber pad and sealing head etc..SARTHAK BIOTECH Pvt. b) The connection is then cut off by taking out the plug top from the socket. & Exp. A logbook is kept for each machine of operation in the format given in annexure 1 ANNEXURE-I LOG BOOK M/C: PP CAP SEALING MACHINE Date Start Time Finish Time Total hrs.……………………….….A.……….……………………. Sector-3.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. …………………….………………………. Sector-3. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. HSIIDC.A.… Sign. KARNAL-132 001 (HR. Sign. Q/C Manager.A. Manager Director Sign.……. Karnal. Production Chemist Production Manager Q. Black Particle on white background. 198-A.. Ltd.. Inspection of filled unit in front of illuminated light for following type of foreign particle: a.……….….: SPD/85 Effective Date: 15-07-2007 Revision No.SARTHAK BIOTECH Pvt.1. . Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Ltd. 5) PROCEDURE : 5.: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR VISUAL INSPECTION OF LIQUID ORALS Page : 01-02 Deptt. To lay down a Procedure for Visual Inspection of Orals Liquid..……….. K..……..: Exp.5 The OK material is transfer in approved quarantine alongwith the status label.…. 5.C. Sector-3.. RECORD OF INSPECTION OF BOTTLE/AMPOULES Product: Mfg Date. name of inspectors.6 Record is to be maintained stating the date. White Particle on black background. Glass Particle on black background. 5.4 The Status Label of rejection are kept with rejection containers. KARNAL-132 001 (HR.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: Batch No. black & white particle) breakage and damage seal. 5. Manager Director Sign.… Sign. 198-A. 5. e. Dept. Sign. Fibers on black background.) STANDARD OPERATING PROCEDURE b.……………………..A.SARTHAK BIOTECH Pvt. c.2 After checking of these particle on inspection board unit are to be sent for labeling & packing after getting O. rejection (as fibred. By glass Fiber Black White particles particles particles Damage seal % of Rejection .………. report from Q. Production Chemist Production Manager Q. glass particle.: PRODUCTION SOP No. Ltd.………. percentage of rejection. Date: Qty of Bottle Received for visual inspection: Date of Inspected Rejection Rejection Rejection Rejection Breakage Insp. 5. HSIIDC.………………………. TITLE: SOP FOR VISUAL INSPECTION OF LIQUID ORALS Page : 02-02 Deptt. d. Sign. Rubber Particle on black background.3 Units with particles are to be kept aside for rejection.: SPD/85 Effective Date: 15-07-2007 Revision No. Production Chemist Production Manager Q. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.… Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: PRODUCTION SOP No.A.SARTHAK BIOTECH Pvt.………. Manager Director Sign. Karnal.2. 5) PROCEDURE : 5. Q/C Manager. 198-A. Keep aside the lid and other part of tanks.. HSIIDC. 5. Sign..……………………... KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE Signature of Production Manager TITLE: SOP FOR CLEANING OF S. 1) PURPOSE : To lay down a Procedure for Cleaning of S. .………………………. Tanks and Stirrer (Liquid Section). Ltd. Transfer the tanks with stirrer in the washing area. Sector-3.…….1.………. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.S TANKS & STIRRER Page : 01-01 (LIQUID SECTION) Deptt.S.….. Sign. Ltd.: SPD/86 Effective Date: 15-07-2007 Revision No.A. 5.…….) STANDARD OPERATING PROCEDURE 5. Water. 5) PROCEDURE : 5.…. GRANULATION & PUNCHING Page : 01-02 Deptt.A. Q/C Manager.M.3. 198-A. KARNAL-132 001 (HR. 5.4..5. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Fix the lid properly.: SPD/87 Effective Date: 15-07-2007 Revision No.. Before starting.… Sign. Karnal. Manager Director Sign.M. ensure that the every bag is properly tagged from store department.SARTHAK BIOTECH Pvt. Wash with D.. Sign.M. Wash the lid similarly.…………………….1.A.2. 5. Affix a status label “CLEAN” and date.6. 5. HSIIDC.………. Again rinse with D. Requisition. Washing to be monitor by Q.1% Teepol solution using nylon brush. Granulation and Punching.7.: PRODUCTION SOP No. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Take the active & non-active contents on per product requirement mention in R. Ltd. . water and drain off completely. Ltd. 1) PURPOSE : To lay down a Procedure for Mixing. TITLE: SOP FOR MIXING. 5. Scrub with 0.. Flush the tank and stirrer with D. Sign. Sector-3.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.M.. Production Chemist Production Manager Q. Manager regularly. Water to remove all traces of the detergent.……….………………………. report OK.7.… Sign. Send the granules for compression. 5. Send granules for bulk analysis.17. Sign.8.: PRODUCTION SOP No. variation of tablet. Transfer the granules in drums & check the wt.. Prepare the binder. & drop the job card in drum.) STANDARD OPERATING PROCEDURE 5.. Before starting the compression ensure the cleaning & wash water analysis report.5. KARNAL-132 001 (HR. 5. Cross.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.………………………. 5. 5. Sign. Ltd. 5.3. Check the cleaning of granulation area.13.9.6. 198-A.14.4. Shift all active & non-active material by sifter.. Sector-3. Add the binder in mass mixer & rotate as the dens mass is formed.…………………….: SPD/87 Effective Date: 15-07-2007 Revision No. Start the compression & check the hardness & wt. 5.….C.A. 5.SARTHAK BIOTECH Pvt. Rotate the mass mixer as the time mention in master formula.11.18.12. 5. TITLE: SOP FOR MIXING.15. When the moisture content is below 2% unload the granule & add lubricants in granules as mention in master formula.………. GRANULATION & PUNCHING Page : 02-02 Deptt. 5. 5. 5. 5. After getting the Q. Pass the mass through multimill. Production Chemist Production Manager Q.……. 5.10. Manager Director Sign. . check the wt. Transfer the materials in mass mixer for dry mixing as mention in master formula. Ensure that all equipments are ready to use.16. HSIIDC. Dry the granules in FBD as the temperature & time mention in master formula. 5.………. 5. of every bag.. Manager Director Sign.1. Check the status card & job card in container.……….. Ltd.. 198-A. After getting OK the in process report starts the compression. Sign.… Sign.. HSIIDC. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt..….……………………. 3) ACCOUNTABILITY : Production Manager/Q. Transfer the strips in visual inspection area 5. Check the line clearance of visual checking belt.………………………. Karnal. 5) PROCEDURE : 5.A.: SPD/88 Effective Date: 15-07-2007 Revision No.: PRODUCTION SOP No.SARTHAK BIOTECH Pvt.) STANDARD OPERATING PROCEDURE 5.4. KARNAL-132 001 (HR.A.. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. TITLE: SOP FOR STRIP VISUAL INSPECTION Page : 01-01 Deptt.3. Ltd.……. 2) RESPONSIBILITY : Q/C Manager. 5.……….19. Spread the strips on visual belt. . 5.2. 1) PURPOSE : To lay down a Procedure for Strip Visual Inspection. Sign. : SPD/89 Effective Date: 15-07-2007 Revision No. . Q/C Manager.……….7.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1.…………………….1 Check the Equipment Usage and Cleaning Log and ensure that equipment cleaning operation has been recorded. 5) PROCEDURE : 5. Exp. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.… Sign. The cavity should not have any cut as the strips. Check the printing quality of B. The ink should not be spread on the strips. Manager Director Sign.3 Check the temperature. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 01-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.No. Mfg. Production Chemist Production Manager Q. Date & MRP. Check the stripping quality with respect of cutting. KARNAL-132 001 (HR.: PRODUCTION SOP No..1 To lay down a Procedure for Operation and Cleaning of Tablet Compression Machine (Rotary Machine). Ltd.………. PRE START UP: 5. Karnal.1..…….SARTHAK BIOTECH Pvt..) STANDARD OPERATING PROCEDURE 5. Sign. relative humidity and differential pressure of the area and record the details in respective logbooks.. 5.A. 5.A. 5.…. Sector-3. 198-A.……………………….5.2 Visually check the equipment and area for its cleanliness. Ltd.6. Date. HSIIDC. 5.. It should be sharp & straight. Sign. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.1. … Sign. 5.5 If the conditions are within the limit. 5.1.13 Ensure the batch identity.1.……….1. 5.2 OPERATION: 5. 5. 5.1. then start the operation.1. 198-A.1. 5.1.12 Ensure that balance to be used for weighing is calibrated.8 Lubricate the machine with food grade lubricant.11 Get the approval from In Process Quality Assurance Manager to start the operation.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.14 Check the signature of Inprocess Quality Assurance Manager in the approved by column of “INPROCESS STAGE” label of Intermediate Product Container.9 Turn the hand wheel in clockwise direction for two to three rotations. 5.: PRODUCTION SOP No. 5.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR. Ltd.. Production Chemist Production Manager Q.…………………….1 Switch “ON” the main electric supply of the machine.…….1.………………………. which is to be compressed as per the “INPROCESS STAGE” label affixed on the Intermediate Product Container. by checking the balance calibration record. 5. status and weight of the bulk.: SPD/89 Effective Date: 15-07-2007 Revision No.1. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 02-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.1..2. Manager Director Sign.……….1. Ensure that turret rotates smoothly.6 Ensure that the dies punches fitted in the machine are as per the product specification in the Batch Manufacturing Record.1. Sign. . 5.10 Affix the status label on the equipment. 5.7 Check that punches are free in punch guide and upper punches dropped under their own weight. 5..) STANDARD OPERATING PROCEDURE 5..A. do not start the operation and inform to the Engineering department. Sector-3.16 Bring the polythene lined high-density polyethylene container in the compression room for the storage of tablets.1.…. Sign. 5. HSIIDC.4 If the conditions are not within the limit.15 Load the bulk to be compressed in the hopper of machine. . 5. 5.: SPD/89 Effective Date: 15-07-2007 Revision No.8 Switch “ON” the machine by pressing green push button. Manager Director Sign.16 Tear off the “CONTAINER STATUS” label after confirming the details on it and put it in the waste bin. disintegration time and other parameters as specified in Batch Manufacturing Record.………. Production Chemist Production Manager Q. 5.10 Check the tablets for weight variation.…………………….6 Operate the machine in “INCH” mode to check the smooth running of machine. 5.2.2. 5.……. 5.2.2.…. stop the machine.2.2. KARNAL-132 001 (HR. 5.5 Place the duly labeled polythene bag lined high-density polyethylene container below the discharge chute of compression machine. 5.… Sign.2.. 5. thickness.15 Replace the “CONTAINER STATUS” label of polyethylene container with “RECOVERABLES” label. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. if required or as specified in Batch Manufacturing Record.3 Take a polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it. 5. HSIIDC.: PRODUCTION SOP No. 5.2.2.14 Remove the high-density polyethylene container in which the tablets are collected and keep it aside on the container trolly. 5. Sign. Sign..4 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.2.13 Inform In-process quality assurance officer to collect the sample for dissolution test.2.2.A.………………………. friability..) STANDARD OPERATING PROCEDURE 5. Sector-3. Ltd.12 After achieving desired parameters.2.2.2 Set the desired hydraulic pressure of machine.SARTHAK BIOTECH Pvt. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 03-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.11 Adjust the parameters to the desired specifications as specified in Batch Manufacturing Record.. hardness.2. for collection of the compressed tablets.9 Run the machine for two minutes.………. 198-A.7 Start the feeder switch to fill the powder in the feeder. high-density 5. replace it with another polythene lined high-density polyethylene container.3.2.22 Inform the In-Process Quality Assurance Officer to check the parameters. 5.18 Take a fresh polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.23 Check the compressed tablets for In-process test parameters at regular intervals as specified in Batch Manufacturing Record and record the details in In-process Control Chart. Production Chemist Production Manager Q. Manager Director Sign. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 04-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt.…….: PRODUCTION SOP No. 5.3 SHUT DOWN 5. start the operation. 5.3. 5.2.2.……………………….2 Release the pressure in hydraulic system.2. 5.SARTHAK BIOTECH Pvt.3 Switch “OFF” the main electric supply of machine.) STANDARD OPERATING PROCEDURE 5. 5.………. 5.19 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.2.A..4 Transfer the filled tablet containers and recoverables container to the respective place.2.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.25 Take the gross weight of filled container and record the details on “CONTAINER STATUS” label. 5.2.3. Sign..… Sign.…………………….17 Place the “TABLET DE-DUSTER” exactly below the discharge chute of compression machine. . KARNAL-132 001 (HR. Sector-3.. 5. Sign. tie the polythene bag with tie band and keep the container on container trolly. 198-A.1 After completion of operation switch “OFF” the machine by pushing the red button.: SPD/89 Effective Date: 15-07-2007 Revision No.……….….21 Record the operation start time in equipment usage and cleaning log and in Batch Manufacturing Record.20 After getting approval from Quality Assurance Manager. HSIIDC.. 5.24 After the high-density polyethylene container is filled.2. 5.2. Ltd. 5.3. 1.1 Remove the dies.4.5 Clean throughly.5 In case of day end compression (compression operation of batch not completed).4.SARTHAK BIOTECH Pvt. .) STANDARD OPERATING PROCEDURE 5. transfer the bulk.1 Remove the “TO BE CLEANED” Label from the equipment.: PRODUCTION SOP No.4 Clean the machine by dry lint free cloth.7 Affix duly filled “TO BE CLEANED” label on the equipment.1.4 CLEANING: 5.4.2 Record the cleaning start time in the equipment usage and cleaning log. 5.4.4. and dipped in 70% Isopropyl Alcohol for cleaning.4. HSIIDC.2.4.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.4.2. 5.………………………. 5.4. Sign.1.2.……………………. 5.… Sign. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 05-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt. Ltd. tear it off. Tear the label after checking the details on it.3 Clean the punches and dies by vacuum cleaner. AT THE TIME OF PRODUCT CHANGE OVER: 5..4..3.. punches from machine.A.1.………. remaining for compression. 5..2 AT THE TIME OF DAY END AND BATCH CHANGE OVER: 5. KARNAL-132 001 (HR.3. 5.………. 5.2. Sector-3. to the Intermediate Product Container and transfer to respective place.: SPD/89 Effective Date: 15-07-2007 Revision No. Production Chemist Production Manager Q. Sign. Manager Director Sign.1. 5. compression machine after every 3 batches as mentioned in 5.2 Dry the dies and punches with lint free cloth.3 Lubricate the dies and punches with food grade oil and transfer to the respective place.….6 Remove the status label from the equipment.1 5. and put in the waste bin.4. 198-A.3.……. 5. … Sign.4.5 Clean the parts with raw water and ensure that the parts are visually clean. 5. Sign.4.. 5.2.) STANDARD OPERATING PROCEDURE 5.2.…. Sign. 5.4 Remove the change parts of the machine and send to the equipment washing area. 198-A. 5.…….2.………………………. Production Chemist Production Manager Q.2. .4..4. Ltd.4.1 % w/v of Teepol solution & flush with plenty of raw water to remove traces of Teepol solution. KARNAL-132 001 (HR.: PRODUCTION SOP No..7 Finally clean the parts with purified water.…………………….6 Clean the parts with 0.2.11 Record the cleaning details in equipment usage and cleaning log and in area cleaning log.SARTHAK BIOTECH Pvt. 5.4.A. HSIIDC.2. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.4.………. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 06-06 COMPRESSION MACHINE (ROTARY MACHINE) Deptt. Manager Director Sign.10 Dry the parts using dryer..2.: SPD/89 Effective Date: 15-07-2007 Revision No.2.9 Send the rinse water-sampling request to the Quality Assurance department to collect the rinse water sample for analysis of traces as per respective standard operating procedure. Sector-3.……….4.8 Clean the machine body using lint free cloth dipped in potable water followed by dry lint free cloth. 5. .5 If the conditions are within the limit.1. .… Sign. Q/C Manager. 5.2 Visually check the equipment and area for its cleanliness. 5) PROCEDURE : 5.……. then start the operation. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. 198-A..: SPD/90 Effective Date: 15-07-2007 Revision No.…………………….3 Check the temperature. do not start the operation and inform to the Engineering department.….A. Production Chemist Production Manager Q. HSIIDC. Ltd.. Ltd. 5. Sign.1 Check the Equipment Usage and Cleaning Log and ensure that equipmentcleaning operation has been recorded.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 01-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt. 5.SARTHAK BIOTECH Pvt. KARNAL-132 001 (HR.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Tablet compression Machine (Multipunch Machine).1. Sign.1. Karnal.4 If the conditions are not within the limit. Manager Director Sign.1.……….1. 5.: PRODUCTION SOP No.A.1 PRE START UP: 5. Sector-3.……….………………………. relative humidity and differential pressure of the area and record the details in respective logbooks. 1. Sign..1.1.10 Affix the status label on the equipment.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1. 5. 5. Ensure that turret rotates smoothly. 5.2 Set the desired hydraulic pressure of machine.8 Lubricate the machine with food grade lubricant.1.: SPD/90 Effective Date: 15-07-2007 Revision No. 198-A.1.2.1 Switch “ON” the main electric supply of the machine. 5. Sign.………. 5.1. KARNAL-132 001 (HR. status and weight of the bulk. HSIIDC.….: PRODUCTION SOP No.1.) STANDARD OPERATING PROCEDURE 5.7 Check that punches are free in punch guide and upper punches dropped under their own weight. Production Chemist Production Manager Q.3 Take a polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.………. 5.14 Check the signature of Inprocess Quality Assurance Manager in the approved by column of “INPROCESS STAGE” label of Intermediate Product Container. 5.… Sign.…….15 Load the bulk to be compressed in the hopper of machine.16 Bring the polythene lined high-density polyethylene container in the compression room for the storage of tablets.. Sector-3. 5.1. which is to be compressed as per the “INPROCESS STAGE” label affixed on the Intermediate Product Container.1. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 02-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.A.12 Ensure that balance to be used for weighing is calibrated.1. 5.13 Ensure the batch identity. 5.2.2 OPERATION: 5.………………………. ..11 Get the approval from In-Process Quality Assurance Manager to start the operation..9 Turn the hand wheel in clockwise direction for two to three rotations.6 Ensure that the dies punches fitted in the machine are as per the product specification in the Batch Manufacturing Record. 5.2.……………………. 5. Manager Director Sign. 5. Ltd.SARTHAK BIOTECH Pvt. by checking the balance calibration record. 17 Place the “Tablet De-duster” exactly below the discharge chute of compression machine.4 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label. 5. for collection of the compressed tablets.5 Place the duly labeled polythene bag lined high-density polyethylene container below the discharge chute of compression machine. 5. 5.2. 5... disintegration time and other parameters as specified in Batch Manufacturing Record. Production Chemist Production Manager Q. Ltd.: PRODUCTION SOP No.: SPD/90 Effective Date: 15-07-2007 Revision No.2. Sector-3.10 Check the tablets for weight variation.2. high-density 5. 5.6 Operate the machine in “INCH” mode to check the smooth running of machine.2.8 Switch “ON” the machine by pressing green push button.2. 5.2. if required or as specified in Batch Manufacturing Record.……. stop the machine. 198-A. ..9 Run the machine for two minute.2.14 Remove the high-density polyethylene container in which the tablets are collected and keep it aside on the container trolley.11 Adjust the parameters to the desired specifications as specified in Batch Manufacturing Record. 5.) STANDARD OPERATING PROCEDURE 5.………. 5.SARTHAK BIOTECH Pvt. friability.12 After achieving desired parameters. Sign.2. hardness.2. 5. thickness.2.2.7 Start the feeder switch to fill the powder in the feeder.A.15 Replace the “CONTAINER STATUS” label of polyethylene container with “RECOVERABLES” label. HSIIDC.……….….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. KARNAL-132 001 (HR. Sign.. 5.13 Inform In-process quality assurance officer to collect the sample for dissolution test. 5.2.……………………. 5.2. Manager Director Sign.… Sign.16 Tear off the “CONTAINER STATUS” label after confirming the details on it and put it in the waste bin.2.………………………. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 03-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt. 5 In case of day end compression (compression operation of batch not completed). 198-A. Sign. Manager Director Sign.3.2.1 After completion of operation switch “OFF” the machine by pushing the red button. 5.21 Record the operation start time in equipment usage and cleaning log and in Batch Manufacturing Record. Production Chemist Production Manager Q. HSIIDC.19 Weigh the container and write Tare weight of container on the “CONTAINER STATUS” label.3. replace it with another polythene lined high-density polyethylene container.3 Switch “OFF” the main electric supply of machine.) STANDARD OPERATING PROCEDURE 5.2. Sign.……………………….……. start the operation.4 Transfer the filled tablet containers and recoverables container to the respective place.… Sign.. . to the Intermediate Product Container and transfer to respective place.…………………….. 5.2 Release the pressure in hydraulic system. Ltd.3.20 After getting approval from Quality Assurance Manager.3.2.3. 5..3 SHUT DOWN: 5. 5. 5.….2. KARNAL-132 001 (HR.2. 5. 5.18 Take a fresh polythene lined high-density polyethylene container and put the “CONTAINER STATUS” label on it.25 Take the gross weight of filled container and record the details on “CONTAINER STATUS” label.………. 5.2.23 Check the compressed tablets for In-process test parameters at regular intervals as specified in Batch Manufacturing Record and record the details in In process Control Chart.: SPD/90 Effective Date: 15-07-2007 Revision No.……….SARTHAK BIOTECH Pvt.A. tie the polythene bag with tie band and keep the container on container trolley.2. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 04-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt.: PRODUCTION SOP No. Sector-3. 5.2. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt..22 Inform the In Process Quality Assurance Officer to check the parameters. 5.24 After the high-density polyethylene container is filled. 5. remaining for compression. transfer the bulk. 1.5 5.2 Record the cleaning start time in the equipment usage and cleaning log.…………………….2..1 Remove the “TO BE CLEANED” Label from the equipment. Sector-3.4.SARTHAK BIOTECH Pvt.1.1. Ltd.3 Lubricate the dies and punches with food grade oil and transfer to the respective place.A.2.4.4 Remove the change parts of the machine and send to the equipment washing area. 5. 5.2 Clean thoroughly. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 05-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt. and put in the dustbin.4.…….1.) STANDARD OPERATING PROCEDURE 5.: PRODUCTION SOP No. AT THE TIME OF PRODUCT CHANGE OVER: 5. Sign. HSIIDC.. Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 5. Tear the label after checking the details on it.2.…. 5. 5.2.2. tear it off.4.7 Affix duly filled “TO BE CLEANED” label on the equipment.… Sign.……….. 5. .4. compression machine after every three batches as mentioned in 5.3 Clean the punches and dies by vacuum cleaner.6 Remove the status label from the equipment.………. punches from machine. Dry the dies and punches with lint free cloth.3.: SPD/90 Effective Date: 15-07-2007 Revision No. 5.3.4. Manager Director Sign.1 AT THE TIME OF DAY END AND BATCH CHANGE OVER: 5.4 CLEANING: 5. 5.. KARNAL-132 001 (HR.4.4.1.4.………………………. 198-A.4.4.4 Clean the machine by dry lint free cloth.2 Remove the dies. and dipped in 70% v/v Isopropyl Alcohol for cleaning.4. Production Chemist Production Manager Q. 5. …. TITLE: SOP FOR OPERATION AND CLEANING OF TABLET Page : 06-06 COMPRESSION MACHINE (MULTIPUNCHING MACHINE) Deptt. 198-A.11 Record the cleaning details in equipment usage and cleaning log and in area cleaning log. Sign.8 Clean the machine body using lint free cloth dipped in potable water followed by dry lint free cloth.) STANDARD OPERATING PROCEDURE 5. Ltd. 5.5 Clean the parts with raw water and ensure that the parts are visually clean.……….6 Clean the parts with 0.. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign. Manager Director Sign. 5.9 Send the rinse water-sampling request to the Quality Assurance department to collect the rinse water sample for analysis of traces as per respective standard operating procedure.: SPD/90 Effective Date: 15-07-2007 Revision No.2.4.………………………. KARNAL-132 001 (HR.4.7 Finally clean the parts with purified water.4..4. 5.10 Dry the parts using dryer.……………………..4. .2.……. Production Chemist Production Manager Q.2..1 % w/v of Teepol solution & flush with plenty of raw water to remove traces of Teepol solution.4.: PRODUCTION SOP No.2.SARTHAK BIOTECH Pvt.4.A.2. 5. Sign.2.……….2. HSIIDC. Sector-3. 5. HSIIDC. 1) PURPOSE : To lay down a Procedure for Operation of Tube Filling. Q/C Manager. Sign.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: SPD/91 Effective Date: 15-07-2007 Revision No..: PRODUCTION MACHINE (TOPICAL SECTION) SOP No. Dept. Karnal. Sign. Rinse twice with tap water followed by twice with purified water IP.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION OF TUBE FILLING..SARTHAK BIOTECH Pvt. Dept..C. Request Q.. Ltd. Sector-3. Dismantle the hopper & filling nozzle & clean it throughly with jet of water. 4.C. Clean machine body & other parts of the machine. Manager Director Sign. OPERATION:1. Cleaning. Ltd. (which cannot be detached) with a wet cloth followed by a dry cloth.A. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Sealing.… Sign. 5) PROCEDURE : Cleaning:- 1. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Put “CLEAN” equipment tag after getting approval from Q.2% teepol solution to remove the deposited medicine.………………………. . 3. SEALING.….……….. 198-A. Production Chemist Production Manager Q. Load the ointment (to be filled) in the hopper. KARNAL-132 001 (HR. Use 0.……………………. to withdraw sample of wash water. Crimping and Batch Coding Machine (Topical Section).A. Page : 01-02 CLEANING. CRIMPING & BATCH CODING Deptt.…….………. 2. C) Batch Coding: . check the finishing of crimped tubes regularly & also ensure that tubes don't get pressurized during crimping. CRIMPING & BATCH CODING Deptt.. Fit filling nozzle of appropriate size. SEALING. Manager Director Sign.…. Ltd. Run the machine for 2 minutes but do not fill the product in the tubes.… Sign. A) Tube Filling: . KARNAL-132 001 (HR. TITLE: SOP FOR OPERATION OF TUBE FILLING. 3.Crimp each tube ... print it on the tube and cross check with the B.Set the batch No. Sign. Page : 02-02 CLEANING.) STANDARD OPERATING PROCEDURE 2. Sign.Adjust if necessary. After 2 minutes.R .……………………….: SPD/91 Effective Date: 15-07-2007 Revision No.Load clean tubes in the filling trays fill the hopper of filling machine with product and cover it.SARTHAK BIOTECH Pvt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 198-A.A. Sector-3.……. Production Chemist Production Manager Q. set fill weight as per requirement.……….………. The print must be clear..P. HSIIDC. check average weight per stroke . Adjust weight.……………………. B) Crimping :. Check weights / Crimping & batch coding every 45 minutes. folding & crimping & start filling operation.: PRODUCTION MACHINE (TOPICAL SECTION) SOP No. . . 2. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……………………. Sector-3. & Mfg. It not displayed clearly. CLEANING & PACKING OF Page : 01-01 TUBES Deptt.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR INSPECTION. It is therefore necessary to clean the tube as early as possible after filling.………………………. CLEANING & INSPECTION: .. 4. If this cream is not removed early. Batch No. Collapsed tubes. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. 1) PURPOSE : To lay down a Procedure for Inspection.…….A.SARTHAK BIOTECH Pvt. 6.. Reject the tube with following characteristics: 1.… Sign. Q/C Manager..…. Ltd. 3. Crimping is not proper. 5) PROCEDURE : Introduction: The base of the cream and ointments is generally petroleum. .. 198-A.………. Printing and paint has peeled off.Inspect each filled tube individually..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. some amount of cream sticks to the outer surfaces of tubes.A. Paint is soluble in petroleum bases. Ltd. DT. Sign. Tube is punctured. Production Chemist Production Manager Q.: PRODUCTION SOP No. HSIIDC.………. KARNAL-132 001 (HR. 5. low weight tubes.: SPD/92 Effective Date: 15-07-2007 Revision No. Sign. During filling and other process of mfg. Manager Director Sign. Karnal. Empty tubes. the paint on the outer side of the tube may come off. Cleaning and Packing of Tubes. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.… Sign. . 5) PROCEDURE : (A) (B) PARENTERAL SECTION: 1. Sign.……………………….A.The ampoules.………. Destruction of batches due to other reasons: ..….The batches failing in sterility are autoclaved or D. Ltd. Manager Director Sign. Toxic batches are neutralised before destruction. 2) RESPONSIBILITY : Q/C Manager.………. Sign. Sector-3. Production Chemist Production Manager Q. Pack the tube in the unit carton or as described in this master formula. Karnal. Destruction of batches failing in sterility: .…………………….: SPD/93 Effective Date: 15-07-2007 Revision No. EXTERNAL APPLICATION SECTION: 1..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.: PRODUCTION SOP No..A.H. HSIIDC. Check that tubes paint & printing is not damaged during cleaning. 2. 198-A. Ltd. TITLE: SOP FOR BATCH DESTRUCTION Page : 01-01 Deptt. 1) PURPOSE : To lay down a Procedure for Batch Destruction.) STANDARD OPERATING PROCEDURE Put “RED COLOUR” identification tag in the rejected tubes tray COLOUR” identification tag in the approved tubes tray.S in case of oily prepn.. KARNAL-132 001 (HR. bottles are broken & solution drained in the sewer. Remove the preparation from the tube. 3) ACCOUNTABILITY : Production Manager/Q.. and “GREEN PROCEDURE: Take a damp cloth & clean the tube surface followed by cleaning with a dry cloth.SARTHAK BIOTECH Pvt.……. Before destruction. ) This mixer is used to prepare homogeneous batches of Semi Solid nature.A.Planetary mixer consists of a motor.SARTHAK BIOTECH Pvt. It is called planetary mixer due to its rotation which resembles that of planets.. . Sector-3. 1) PURPOSE : To lay down a Procedure for Cleaning and Operation of Palnetary Mixer Q/C Manager. a gearbox to control speed of stirrer.. a handle to move tank up and down and a lid to cover the tank. Sign. Now motor is in neutral gear. Ltd.……………………. Production Chemist Production Manager Q.………. Dig & bury the cream underground.A.Planetary mixer is used for preparing batches of creams.… Sign.…. 4. KARNAL-132 001 (HR. 5) PROCEDURE : INTRODUCTION: . Karnal.) STANDARD OPERATING PROCEDURE 2. Raise the tank by moving the handle clockwise to fit the tank on the lid . Ltd.………. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 01-02 PLANETARY MIXER Deptt. first gear. Sign. stirring blade. Assemble the stirrer blade inside the tank and place items to be mixed in the tank 3. Switch on motor by pressing green button on the starter. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. Take the jacketed tank and load it on the mixer. Operation:1.: PRODUCTION SOP No.: SPD/94 Effective Date: 15-07-2007 Revision No. 198-A. 2. Manager Director Sign.……………………….. IInd gear or IIIrd gear. (Planets revolve on their axis and also around sun.e.…….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. a jacketed tank. Shift the gear as the speed required i. Construction: . ointments & gels etc.. HSIIDC.. . 6. KARNAL-132 001 (HR.C. stirrer shaft & blades and lid of the tank with tap water.M. Sector-3. 4. Production Chemist Production Manager Q. HSIIDC.P..………. and ask Q.… Sign. 2. 2 Ltrs 2% Teepol soln. 5. 10 Ltrs Hot water (60oC). 7. Bring the tank down by rotating the handle anticlockwise. 50 Ltrs D. Sign.M. 198-A. 3. Sign.Deptt to withdraw sample of wash water and give test report.SARTHAK BIOTECH Pvt. 2 ltrs water) Procedure: 1.. Put “CLEAN” equipment tag on the mixer when lab approves the wash water.…………………….……….A. Scrub tank.: PRODUCTION SOP No. 7. Use hot water to remove deposited material. Make entry in equipment logbook. Drain the water. 6.s.. Manager Director Sign. Rinse all parts with tap water thrice. water I.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Switch off the stirrer when mixing is complete by pushing red button on the starter. Pass hot or cold water through the jacket of stirrer if required. 3. Fibre free plastic brush. TITLE: SOP FOR CLEANING AND OPERATION OF Page : 02-02 PLANETARY MIXER Deptt. Hose down sides of the tank.…. water I. .: SPD/94 Effective Date: 15-07-2007 Revision No. 2.) STANDARD OPERATING PROCEDURE 5. 4.……………………….P. Ltd.……. Drain the water & rinse tank with D. Cleaning of Planetary Mixer: Requirements: 1. (40 ml teepol + q. shaft blades etc with teepol solution & brush. Keep mixer covered with lid. Remove tank & stirrer blade from the stand and cover them. Check direction of rotation of mill.A.…. 6.Drain the water. Karnal.C Deptt. 2.: PRODUCTION SOP No. Q/C Manager. 5) PROCEDURE : CLEANING:- 1.………………………. KARNAL-132 001 (HR.. 2. Sign.2% teepol solution rinse with several washes of water.SARTHAK BIOTECH Pvt.……. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.…………………….Request Q.C Dept.A. Refill purified water IP in the hopper & run the machine for 2 minutes . Drain the water.… Sign.. Put clean equipment tag in the machine after getting approval from Q. Production Chemist Production Manager Q. 5. Ltd.………. Sector-3.. HSIIDC. Drain the water.………. it must be clock wise. Detach hopper and wash with 0.. Operation and Maintenance of Colloidal Mill. Take hot water & repeat the above process. Manager Director Sign. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. . Take purified water IP in the hopper & run the machine for 2 minutes. OPERATION & Page : 01-01 MAINTENANCE OF COLLOIDAL MILL Deptt. Fill water in hopper & operate the machine so that medicine in the grinding slit is also removed .: SPD/95 Effective Date: 15-07-2007 Revision No. 3. 4. Sign. Fit it back to its position.. Ltd. 198-A.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR CLEANING. to withdraw sample of wash water. 1) PURPOSE : To lay down a Procedure for Cleaning. Fill the hopper with liquid & start milling. OPERATION:1. Q/C Manager. 1) PURPOSE : To lay down a Procedure for Washing and Cleaning of Equipments (External Preparation Section). 5. Ltd.……….: SPD/96 Effective Date: 15-07-2007 Revision No. 5) PROCEDURE : 5. Sign.Deptt to withdraw sample of wash water and give test report. shaft blades etc with teepol solution & brush.C..SARTHAK BIOTECH Pvt. Switch off the machine after completion of milling. Sign.… Sign.3 Rinse all parts with tap water thrice.A. 198-A. Use hot water to remove deposited material.. 4.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Production Chemist Production Manager Q.6 Make entry in equipment log book.. 5.P.……………………. 5. Manager Director Sign. Drain the water. TITLE: SOP FOR WASHING & CLEANING OF EQUIPMENTS Page : 01-01 (EXTERNAL PREPARATION SECTION) Deptt. Enlarge the grinding slit & restart.A.) STANDARD OPERATING PROCEDURE 3. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……………………….: PRODUCTION SOP No. and ask Q. Ltd. KARNAL-132 001 (HR. 5.2 Scrub tank.4 Drain the water & rinse tank with purified water I. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q. 5.1 Wash down sides of the tank.……….5 Keep mixer covered with lid. Karnal.…….. In case the mill stops abruptly switch it off. .…. stirrer shaft & blades and lid of the tank with tap water. HSIIDC. Sector-3.. : Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. tank by LPG gas stove 1. Shampoo. 1.1.. Q/C Manager. Sign.………..) Ointment 3. Gum-Paint etc.7 Add any leftover Raw material.A.3 Add any raw material to above phases as per direction given in MFR.1 PROCEDURE FOR CREAM:1.1.……………………. This will take 6-7 hours in summer & 3-4 hours in winter.: SPD/97 Effective Date: 15-07-2007 Revision No.2 Heat oily base in S. .…. Manager Director Sign.… Sign.A. KARNAL-132 001 (HR. 5.1.1.4 Filter the oily phase into planetary mixer tank.7 Put clean equipment tag on the mixer when lab approves the wash water.SARTHAK BIOTECH Pvt. Karnal.6 Switch on planetary mixer & continue till cream formation tanks place. TITLE: SOP FOR BATCH PREPARATION OF EXTERNAL Page : 01-02 PREPARATION Deptt. 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.: PRODUCTION SOP No.. 1.……….S. Sign.8 Check weight of batch add purified water to make up weight...S. 1.) STANDARD OPERATING PROCEDURE 5. 198-A.………………………. 1.1. Ltd.1. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 1.) Liquid e. 5) PROCEDURE : Three types of batches are prepared in external application section viz: 1.5 Now filter aqueous phase into planetary mixer tank.) Cream 2. Sector-3. Production Chemist Production Manager Q. HSIIDC.1 Heat aqueous base in S. tank by LP G gas stove .……. Ltd.g. 1.1. 1) PURPOSE : To lay down a Procedure for Batch Preparation of External Preparation.1. Sign.2 PROCEDURE FOR OINTMENT:As the Ointment generally do not contain water..3 A.S. 5. C. 1.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.9 After all the ingredients has been added & weight of batch has been made upto mark switch on shrives & continue for minimum one hour. Add raw material as per MFR & shrive.…. 198-A. Check WFI batch & send sample for bulk analysis. Sector-3. 1.……….: PRODUCTION SOP No. Protect the batch from water. KARNAL-132 001 (HR. Make up volume & send sample for bulk analysis. TITLE: SOP FOR BATCH PREPARATION OF EXTERNAL Page : 02-02 PREPARATION Deptt.S.A.. Production Chemist Production Manager Q. Sign. B.: SPD/97 Effective Date: 15-07-2007 Revision No.… Sign. Add raw material as per MFR shrive.SARTHAK BIOTECH Pvt. Ltd. Manager Director Sign. .……….……………………. Take measured quantity of base in the S..1. Use dry equipment only. Take the base in S. send sample for bulk analysis. The batch with a scoop till solidifier.) STANDARD OPERATING PROCEDURE 1.…….1. PROCEDURE FOR LIQUIDS:- A.10 Pass the batch through colloid mill. table B.………………………. container & heat to melt. C. HSIIDC. D.. …….Equipment or machine parts like syringe should be completely disassembled to render complete cleaning .………. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. STIRRER & MACHINE Deptt. To lay down a Procedure for Washing.. 198-A.5 Water for injection. Manager Director Sign. Sign. 5) REQUIREMENTS : 6.6 Butter paper & rubber bands. Karnal.4 Purified water 5. Ltd.……….) STANDARD OPERATING PROCEDURE TITLE: SOP FOR WASHING. Q/C Manager. Stirrer and Machine Parts for Ointment and Cream. 5.3 Potable water 5. Cleaning and Storage of Equipment.SARTHAK BIOTECH Pvt. Sign. 5. Sector-3. Production Chemist Production Manager Q.A. 1) PURPOSE : 2) RESPONSIBILITY : 3) ACCOUNTABILITY : Production Manager/Q.….2% Teepol solution.… Sign. Vessels. HSIIDC. PROCEDURE: Following steps are involved: 6.: SPD/98 Effective Date: 15-07-2007 Revision No.1 EQUIPMENT DISASSEMBLY: . KARNAL-132 001 (HR. 5..VESSELS.A. . Ltd.2 Scrubbing brush.: PRODUCTION PARTS FOR OINTMENT & CREAM SOP No.……………………..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.……………………….1 0. 5... CLEANING & STORAGE OF Page : 01-02 EQUIPMENT. STORAGE OF CLEAN EQUIPMENTS: .: SPD/98 Effective Date: 15-07-2007 Revision No. Sector-3. Dept to withdraw sample of wash water & send their results for the testing of detergent & last batch traces.………. Ltd.After completion of washing. Sign. washed articles should be stored under conditions.. 6. 6.3 SCRUBBING: . possible components should be covered with lid or with butter paper or aluminum foils. 198-A. which minimize the risk of contamination by particulate matter & after sterilization by viable organisms.……………………. 6. 6. scrub all equipments to remove stains. TITLE: SOP FOR WASHING.C.A. To the extent..… Sign.: PRODUCTION PARTS FOR OINTMENT & CREAM SOP No.Rinse all washed articles twice each with purified water followed by water for injection. Sign.……………………….Request Q.…….) STANDARD OPERATING PROCEDURE 6..5 FINAL RINSE: .2 PRE-WASH: .2% teepol solution. Manager Director Sign.Collect all the vessels to be washed in the washing section & sprinkle hot water over them. Production Chemist Production Manager Q. . Keep equipment & machine parts in hot water for 30 minutes.Rinse with potable water until they are free from teepol. Put clean equipment tag after getting approval from Q.SARTHAK BIOTECH Pvt.With a plastic brush soaked in 0.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.VESSELS.C Dept. CLEANING & STORAGE OF Page : 02-02 EQUIPMENT. 7. STIRRER & MACHINE Deptt.….……….6 WASH WATER ANALYSIS: . HSIIDC..4 INITIAL RINSE: . KARNAL-132 001 (HR. medicine depositions etc. 2. PROCEDURE: : MACHINE NAME: COATING PAN M/C No. c) Carry out coating operation as per the standard procedure laid down in the product BMR.: SPD/99 Effective Date: 15-07-2007 Revision No. 2) Compressed air pressure 3) Rate of atomizing air pressure. Sign. 1..A.: PRODUCTION SOP No.A. Ltd. KARNAL-132 001 (HR.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sector-3. b) Arrange the position of hot air blower and exhaust system.Load weighed quantity of uncoated tablets from the containers into the coating pan.SARTHAK BIOTECH Pvt. RESPONSIBILITY : Q/C Manager.………………………. SCOPE The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. Production Chemist Production Manager Q. 198-A. Karnal. Following parameters must be strictly adhered to: 1) Required temperature of the bed.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR COATING PAN Page : 01-02 Deptt.………. HSIIDC. Ltd.…………………….…. ACCOUNTABILITY : Production Manager/Q. PURPOSE : To lay down a Procedure for Coating Pan. 5..……. . Sign. 3..……….… Sign. Manager 4.: Loading weighed quantity of uncoated tablets:.. Operation:1) Coating Pan 2) Exhaust System 3) Hot air blower a) Ensure the working and effectiveness of exhaust system and the hot air blower. Manager Director Sign.. Manager Director Sign. Ltd.……. Production Chemist Production Manager Q.SARTHAK BIOTECH Pvt. HSIIDC. check laid down physical parameters of coated tablets as per the laid down procedure in the Product.. KARNAL-132 001 (HR.A. e) Remove the coated tablets from the pan into double poly bags in aluminium containers properly labelled.… Sign.: SPD/99 Effective Date: 15-07-2007 Revision No. Sign.……………………. Sector-3.……….….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.………………………. 198-A.: PRODUCTION SOP No.……….. Sign.) STANDARD OPERATING PROCEDURE 4) Excaust System 5) Spray pattern TITLE: SOP FOR COATING PAN Page : 02-02 Deptt.. d) After completion of coating.. DISMANTLING:- 1) 2) Switch off the mains of the following: a) Hot air blowers b) Exhaust system c) Coating Pan Remove:a) Hot air blowers pipes b) Exhaust Pipes . A. ____________ Date of Release by Q. 5.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.1 Finished formulations are kept in quarantine stores till it is cleared by Q. Karnal. Sign. ____________________________________________ Qty. Sector-3. . Deptt. Date _____________ Batch No. 5) PROCEDURE : 5.C.A..: SPD/100 Effective Date: 15-07-2007 Revision No. 5. transfer to warehouse ________________________________________________ Date of transfer of goods to warehouse ______________________________________ Packing Supervisor Q.………………………. HSIIDC.2 Once cleared by Q.………. ________________________ Exp.……………………. Ltd.. Rs.SARTHAK BIOTECH Pvt. Ltd. ________________________ M. 2) RESPONSIBILITY : Q/C Manager. KARNAL-132 001 (HR.C. 1) PURPOSE : To lay down a Procedure for Transfer of Finished Goods to Finished Goods Strore..R. Q. Deptt. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.A.………….C.D.3 Once the product is packed they are transferred to commercial store vide the transfer note as per the following format: FINISHED GOODS TRANSFER NOTE Product Name ____________________ Mfg. 3) ACCOUNTABILITY : Production Manager/Q.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR TRANSFER OF FINISHED GOODS TO Page : 01-02 FINISHED GOODS STORE Deptt. Manager Director Sign.C. Sign. They are packed in strips/blister strip/bottles/jars etc. Production Chemist Production Manager Q. No.: PRODUCTION SOP No. Deptt. Date _____________ A.… Sign.……. as per the individual case. 198-A.R.D.P. ……….…….………………………. 198-A. HSIIDC. 5. Sector-3. Production Chemist Production Manager Q. Sign..…………………….SARTHAK BIOTECH Pvt.5 Production dept. Units Transferred No.4 Once the Product is transferred they are kept Product-wise with separate identity Slip/BIN Card attached.: PRODUCTION SOP No. Ltd. Manager Director Sign. 5.… Sign. Sign. maintains a register indicating daily transfer details in the following format: Date Product Batch No.A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. KARNAL-132 001 (HR.) STANDARD OPERATING PROCEDURE TITLE: SOP FOR TRANSFER OF FINISHED GOODS TO Page : 02-02 FINISHED GOODS STORE Deptt.: SPD/100 Effective Date: 15-07-2007 Revision No. of cases Sent by Received by .………….. Sign.……….SARTHAK BIOTECH Pvt. 5) PROCEDURE : The entire Machine Operation is divided in three stages.……………………. Sign. HSIIDC. Ltd.……………………….3 Post Operative Cleaning and equipment preparation.: SPD/101 Effective Date: 15-07-2007 Revision No.A.1 Pre-operative Cleaning & Setting.………….) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF TRAY Page : 01-03 DRIER Deptt.……... STAGE – II a) The machine is switched on and run for few seconds to observe whether it is running normally or not.A. etc. Manager Director Sign. KARNAL-132 001 (HR. 3) ACCOUNTABILITY : Production Manager/Q. for rectification. Batch No. . 2) RESPONSIBILITY : Q/C Manager.2 Operation 5. 1) PURPOSE : To lay down a Procedure for Operation and Cleaning of Tray Drier. b) The exterior of the machine is cleaned with dry cloth. Ltd. 5. Karnal. 5. Production Chemist Production Manager Q.: PRODUCTION SOP No. d) Arrange a polythene bag kept in a plastic drum for storage of dried granules/material. b) If any abnormal sound is heard the machine is referred to maintenance deptt.… Sign. Sector-3. STAGE – I a) The electrical connections are restored by pulling the plug top into the socket. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 198-A. c) Put the granule & powder in the trays & kept for drying. is put on the top cover of the machine. c) The “MACHINE READY FOR USE” Sticker is removed and sticker/tag showing product.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.. stop the drying. d) Then set the required temperature & drying time for 30 minutes & start the machine. STAGE – III a) The connection is cut off by taking out the plug to from the socket. 198-A.C. d) Once the wash water analysis is cleared by Q.D. Sector-3. f) Again start the machine check the granules in between. c) The trays are thoroughly washed with the help of detergent & wash with water till the to am is washed out then wash with D.…………. set the machine.M.: PRODUCTION SOP No. TITLE: SOP FOR OPERATION & CLEANING OF TRAY Page : 03-03 .D.D. i) In case of batch change the contact parts are cleaned with dry clothes. Sign.. KARNAL-132 001 (HR. e) After 30 minutes stop the machine & manipulate the material of trays.B. h) The process is continued till the entire granules are dried.… Sign. A sticker starting “MACHINE READY FOR USE” in put on the machine to render it ready for use.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.C.………………………. Below the F.A. HSIIDC.SARTHAK BIOTECH Pvt. Sign.……. Water. render the machine is ready for further use. g) Check the moisture content of granules if found under the limit.………. continue the drying till the required moisture content is obtained collect the granules in a plastic bag in a fiber drum. Manager Director Sign. If not. Production Chemist Production Manager Q.…………………….) STANDARD OPERATING PROCEDURE TITLE: SOP FOR OPERATION & CLEANING OF TRAY Page : 02-03 DRIER Deptt. j) Once the process is over put the sticker starting “to be cleaned” on the machine. k) In case of product or composition change the entire machine is washed and wash water analysis is to be done to by Q. Ltd.: SPD/101 Effective Date: 15-07-2007 Revision No.. b) After the days operation a product change or change of composition the sticker starting “ to be cleaned” is removed. Machine/Equipment Code: SOP No.. Sign.. Date Start Time Finish Time Total Hours of Running Break Down START END Down Time Hours TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE Production/ Batch No.: PRODUCTION ....:……….: SPD/101 Effective Date: 15-07-2007 Revision No..) STANDARD OPERATING PROCEDURE DRIER Deptt..: SPD/10 Location:……….……………………. Sign. Production Chemist Production Manager Q.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. HSIIDC.………………………..…………...SARTHAK BIOTECH Pvt. Sector-3.…….: PRODUCTION SOP No. A logbook is kept for each machine of aeration in the following format: LOG BOOK OF MACHINE/EQUIPMENT Name of Machine/Equipments: TRAY DRIER Page No.……….………... Operated By Checked By Page : 01-03 Deptt. 198-A..… Sign. Ltd. KARNAL-132 001 (HR. Manager Director Sign..A.………. : SPD/102 Effective Date: 15-07-2007 Revision No.A. Ltd. 5.6 Check the set the temperature of the pre-heater top heater top platen. Sector-3. Ltd.……………………….…………………….7 Manually switch ‘OFF’ the pneumatically operated basic valve lever to pinch roller that is located on the indexing unit.………….… Sign. Sign.A.SARTHAK BIOTECH Pvt. 5.. Production Chemist Production Manager Q. 2) RESPONSIBILITY : Q/C Manager. 1) PURPOSE : To lay down a Procedure for Oeration and Cleaning of ALU-ALU Pack Machine. 150 mm from the machine body surface to the center of the reel. 198-A.: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE Page : 02-03 Deptt. 5.8 Then pass the base film to the indexing unit through pre – heater platen in between the top platen and bottom platen through dancing arm and guide rollers to the sealing station though the forming die and blow head of forming station pass over the web guide track. Manager Director Sign.9 On the MMI (Man – Machine Interface) recalled the program for particular formatting by switch ‘ON’ control panel and scrolling the MMI screen by entering the multiple level of password.3 Load the base material on to the base material reel feed shaft. HSIIDC. Sign. 5.: PRODUCTION . 3) ACCOUNTABILITY : Production Manager/Q.. 5.5 Load the lidding foil on the lidding foil red feed shaft. 5. 5.4 Maintain the distance of approx.) STANDARD OPERATING PROCEDURE SOP No.1 Switch ‘ON’ the main supply of the machine 5.……. Karnal.. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. bottom platen and sealing heater according to the base material and lidding material on the MMI.……….2 Switch ‘ON’ compressed air and chilled water to the machine. KARNAL-132 001 (HR. 5) PROCEDURE : OPERATION 5. : Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. Sign. 198-A. Machine run for few cycles and then switches ‘OFF’ the machine.A.21 Then pass the sealed web to the punching station where the quality blister pack punches out.………. TITLE: SOP FOR OPERATION & CLEANING OF ALU-ALU PACK MACHINE Page : 03-03 Deptt. 5. HSIIDC.: PRODUCTION . Production Chemist Production Manager Q. Then STOP the machine by pressing red push button and check for the blister pack correctness. 5. 5.. 5. KARNAL-132 001 (HR. 5.……. 5.) STANDARD OPERATING PROCEDURE SOP No. 5.24 For any adjustment in sealing station for proper engagement of form blisters to the sealing die easily by moving the stations horizontally at LHS or RHS at required position.20 Then STOP the machine by pressing red push button and check the sealing performance.… Sign.17 Drawn the Sealing / Lidding foil to the sealing station over the formed web passes through the batch code printing station.18 Press the ‘START’ switch again for RUN the machine.10 Enter all the information in the formatting part according to the product..: SPD/102 Effective Date: 15-07-2007 Revision No. Sector-3. 5.13 Manually switch ‘ON’ the pneumatically operated basic value lever for engagement of pinch roller with indexing roller. 5. 5. 5. Manager Director Sign.19 RUN the machine in the ‘RUN MODE’ for few cycles.12 Check all the safety guards are locked or closed.16 Check the formed web for consisting of the form of blisters and the quality parameters of the formed web.…………………….14 Then switch ‘ON’ the machine in ‘RUN MODE’ by pressing the ‘START’ push button. 5.15 The machine will form the blister in a continuous web from.…………. 5.SARTHAK BIOTECH Pvt.22 Again press ‘START’ push button.23 RUN the machine in the ‘RUN MODE’ for few cycles. Sign.11 Switch ‘OFF’ the product feeding system. 5. Ltd. 5.………………………. 198-A. 5..……….……………………….: SPD/103 Effective Date: 15-07-2007 Revision No..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt.… Sign. Ltd.……. Sector-3. HSIIDC.…………. Sign.1 Cleaning the machine with mild hot distilled water. 5. CLEANING PROCEDURE : 6.SARTHAK BIOTECH Pvt. 6. 5.A. 5.27 Then waste web pass over the dancing arm trim winding assembly through the guide rollers where the waste firm wound over the trim winding shaft.30 Load the standard and specified input packing materials means base film and lidding foil with their specified dimensions and according with the product. 5.: Page : 01-01 Deptt.) STANDARD OPERATING PROCEDURE SOP No.2 Clean the hopper foil red feed shaft with distilled water. TITLE: SOP FOR OPERATING OF AIR COMPRESSOR SOP No.5 Put the sticker ‘READ TO USE’.28 When the blister packs meet all the quality parameters then adjust the feeding system.25 For proper sealing of form blister web to the lidding foil by adjust the pressure adjustable screws.29 Above all the adjustments have been completed then gradually increase the machine speed recommended by the instruction manual.: PRODUCTION Review Date: 14-07-2009 . Production Chemist Production Manager Q. 5. 6. Manager Director Sign. KARNAL-132 001 (HR.…………………….4 Dry with open cloth.26 For any adjustment in punching station moving the station horizontally at LHS or RHS can do according with blister pack that or RHS at require position. 6) Sign.: SPD/102 Effective Date: 15-07-2007 Revision No. 6. 6.3 Mope all the machine & machine parts with IPA. .SARTHAK BIOTECH Pvt. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. 5.………. 3) ACCOUNTABILITY : Production Manager/Q. Firstly the air passed through carbon column and then silica column. Sector-3. HSIIDC. 5.2 Atmospheric air should come through free filter and is stored in receiver having a safety valve.…………………….) STANDARD OPERATING PROCEDURE Prepared by: Asstt.: Prepared by: Checked By: Page : 01-01 Deptt..…….… Sign.A.…………. 2) RESPONSIBILITY : Q/C Manager. Sign. 198-A.1 Switch on the start switch of panel of air compressor.4 The air is passed through air drier. Now this sterile air ready of use in production. KARNAL-132 001 (HR.: PRODUCTION Review Date: 14-07-2009 Approved By .……………………….2 micron in line air filter. 5. Manager Director Sign. Production Chemist Checked By: Production Manager Approved By Q.. 1) PURPOSE : To lay down a Procedure for Operating of Air Compressor. 5) PROCEDURE : 5.: SPD/104 Effective Date: 15-07-2007 Revision No. Sign.5 Then this air is passed through 0. 5.3 At the pressure of 7 kg or above the main machine releases out the excess air.A. Ltd. Karnal. TITLE: SOP FOR OVER PRINTING ON STRIPS SOP No. Ltd. . Ltd. 5.6 Before starting the stripping the line clearance is checked & approval is taken from Q.4 As the sterio are received. person.. Sign. 2) RESPONSIBILITY : Q/C Manager.: PRODUCTION SOP No. HSIIDC. Production Chemist Production Manager Q. Person.A. & rates are taken from mfg.9 As the stripping starts random.: SPD/105 Effective Date: 15-07-2007 Revision No..) STANDARD OPERATING PROCEDURE Asstt. Mfg.2 For printing the sterio are prepared from approved vendor. Sector-3. Manager Director . TITLE: SOP FOR LEAKAGE CHECK IN FILLED BOTTLE Page : 01-01 Deptt. record. 5. 5. Ltd. 5.……. 5. Director Sign.A.1 As the capsule or tablet passes in analysis the material shifted in stripping area. 1) PURPOSE : To lay down a Procedure for Over Printing on Strips. 5. 5.SARTHAK BIOTECH Pvt. Karnal. Exp.10 If the sample passes the stripping starts. all matter is checked in all respect. No.11 In process check is done after every 30 minutes of strips.………….: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5.… Sign. sample is sent for Leak Test.A. 3) ACCOUNTABILITY : Production Manager/Q..3 For sterio preparation the B.7 Final approval of matter coding on the strip is taken from Q. 5. 198-A.A. KARNAL-132 001 (HR. Production Chemist Production Manager Q.8 The approved foil is preserved in the record..………………………. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.……….A. Manager Sign.……………………. 5. 5) PROCEDURE : OPERATION 5.5 The sterio are fixed on the machine. ……. check the leakage in all bottle.3 Keep all the bottle in inverted position. KARNAL-132 001 (HR.1 Draw the sample atleast 10 containers randomly.: SPD/106 Effective Date: 15-07-2007 Revision No. TITLE: SOP FOR OVER PRINTING ON BOXES & LABELS Page : 01-1 Deptt.. 5.… Sign..: Review Date: 14-07-2009 Prepared by: Checked By: Approved By Asstt. 5. Ltd. HSIIDC. Sign. 2) RESPONSIBILITY : Q/C Manager.A. Ltd.1%.5 If there is any leakage it will be accumulated on the sealing side on the cap.A.……………………. Sector-3.……….4 After 24 hr. 5. Production Chemist Production Manager Q. 5) PROCEDURE : OPERATION 5.………………………. 3) ACCOUNTABILITY : Production Manager/Q.2 Check whether the sealing is PERFECTLY done. 198-A. Manager Director .SARTHAK BIOTECH Pvt.: PRODUCTION SOP No.) STANDARD OPERATING PROCEDURE Sign. 5. Karnal.. 1) PURPOSE : To lay down a Procedure for Leakage Check in Filled Bottle.…………. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt.6 Maximum Tolerance limit is 0. 5. Sign. P.8 After printing of few boxes or labels. 3) ACCOUNTABILITY : Production Manager/Q.A.3 From production department the boxes or labels are sent to batch coding room.5 Before batch coding the sorting of labels & boxes are done. Ltd.………. Mfg.R.……………………….4 First of all the line clearance is checked before starting the work. 1) PURPOSE : To lay down a Procedure for Over Printing on Boxes and Labels. Sign. Ltd. HSIIDC. is given by production Incharge.. 5.……. KARNAL-132 001 (HR.9 If the everything is OK. 5. mention in requisition.…………. Karnal.R.…………………….… Sign. Sector-3. 5) PROCEDURE : OPERATION 5.SARTHAK BIOTECH Pvt.. 5.1 Requisition is issued to the packing material store.A. 5. Manager 4) SCOPE : The procedure of this SOP shall be applicable to Production Department of Sarthak Biotech Pvt. No.. 198-A.P. & M. 5. Sign. REVISION STATUS: NEW .2 According the qty. the boxes or labels are issued from packing material store to production department. the approved packing material is preserve in a register& overprinting starts. 2) RESPONSIBILITY : Q/C Manager. the matter is checked by Q. Exp.) STANDARD OPERATING PROCEDURE Sign.7 For overprinting the B.. 5.6 Percentage rejection is noted in B. 5.. 5. person.