Hold Time Study Sample Protocol.pdf

Pharmaceutical GuidelinesHold Time Study Protocol Document No : PG/HOLD/001 Product : XXXXX Tablets Page No : 1 of 4 1. Purpose : Hold time study is the determination of time period for which the product can be hold at a particular stage & period during processing, under defined storage conditions. Such study will support the maximum time period between various stages during the manufacturing of the product. This protocol will provide the guideline to determine the hold time for different manufacturing stages of XXXXX tablets. 2. Scope : This Protocol provides the guidance for determination of time limitation up to which bulk can be stored before taken for next processing stage up to which time it can be stored in stipulated storage container at stipulated storage conditions. 3. Responsibility: Quality Assurance To prepare protocol. Review of protocol and report. Sampling as per the approved protocol. Conclude the result. And Approval of protocol and result. Quality Control To analyses the hold time study samples as per the approved protocol and report the results. Review of Protocol and report. Production To review the protocol and report. 4. Sampling and Sample Storage: The hold time study for the product shall be carried out on three batches. The officer IPQA shall collect the sample as per protocol during the manufacturing of the planned batches. The representative sample product should be kept in respective quarantined area in manufacturing department in stainless steel container at 25°C. [email protected] © www.pharmaguideline.com com .pharmaguideline.com © www. Hold Time Study Flow Chart : [email protected] Guidelines Hold Time Study Protocol Document No : PG/HOLD/001 Product : XXXXX Tablets Page No : 2 of 4 5. Specification Related substances. Uniformity of dosage units. As per Loss on drying.com As per Specification © www. Dissolution Assay. Microbial test 2. Core Tablets 90 days Initial 30 days 45 days 60 days 90 days 2. Water content. Binder 8 hours Initial 2 hours 5 hours 8 hours 800 ml Appearance. Blend uniformity.0 kg Description. pH. microbial test 6. Dissolution Assay. Related substances. Particle size distribution. As per Sedimentation. Lubricated Blend 45 days Initial 15 days 30 days 45 days 500 gm Loss on drying. Friability. Hardness.Pharmaceutical Guidelines Hold Time Study Protocol Document No : PG/HOLD/001 Sr. Coating Solution 72 hours Initial 12 hours 24 hours 36 hours 48 hours 60 hours 72 hours 800 ml Physical appearance. As per Thickness. Specific Specification gravity. Bulk and tap density. Related substances.pharmaguideline. Microbial test info@pharmaguideline. Microbial test As per Specification 5. Coated Tablets 90 days Initial 30 days 45 days 60 days 90 days 2. No. Microbial test As per Specification 4. Stage Product : XXXXX Tablets Proposed Sampling Fold Time frequency Sample Quantity Page No : 3 of 4 Tests to be Preformed Acceptance Criteria 1.0 kg Description. Hardness. Friability. Particle size distribution. Viscosity. Viscosity. Uniformity of dosage units. Assay.com . Disintegration. Thickness. Granules 45 days Initial 15 days 30 days 45 days 800 gm Description. Bulk and tap density 3. Specification Disintegration. Moisture content. Lubricated Blend 4. Approval Name & Designation Depart ment Signature Date Prepared By Checked By Approved By [email protected]. Any significant change in the result needs to be investigated and addressed properly. Stage 1.No. Granules 3. evaluation & conclusion to be made along with established hold time period. Based on the generated results. Conclusion: _______________________________________________________________________ _________________________________________________________ ______________ 12. Binder 2.Pharmaceutical Guidelines Hold Time Study Protocol Document No : PG/HOLD/001 Product : XXXXX Tablets Page No : 4 of 4 6. Revalidation: The hold time study shall be performed again in case of any major change in product specification. Batch Details: S. Evaluation: The maximum period at which the observation for all the specified tests are within the specification limits shall be the acceptable hold time for the respective intermediate. Re port: Results obtained from the analysis shall be attached in the form of report. No. Acceptance Criteria: The acceptance criteria for all the tests should be same as per the hold time study specification. Core Tablets 5. 7. 11. Coating Solution 6.No. Date 10. Date 3rd Batch B.com © www. Coated Tablets 1st Batch B. 9. Date 2nd Batc h B.No. 8.com .