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HomeAbout Quality Control Quality Assurance Microbiology Production SOPs Download Guest Articles Contact Us Follow Advertise Medical Device Validation Minimize wasted time &cost. Ensure a process for quality molds & parts Home » Quality Control » SOP » SOP for Statistical Study for Trend Analysis of Purified Water and Water for Injection Standard operating procedure to prepare the trend of Purified Water and Water for Injection. Ankur Choudhary | Quality Control | SOP Be the first to comment! Medical Device Validation Minimize wasted time &cost. Ensure a process for quality molds & parts 1.0 OBJECTIVE To evaluate the uniform quality of D.M. water and W.F.I by trend of the results. 2.0 SCOPE This procedure gives guidelines for evaluating the results and to take corrective action if the results exceed action level. 3.0 RESPONSIBILITY 3.1 Doing : Technical Assistant/Executive 3.2 Checking : Executive /Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 Purified Water : For each critical sampling point, prepare a trend report once in a week for following critical parameters. 1. Microbial count 2. Chemical analysis: pH, Conductivity, Total organic carbon. 5.2 W.F.I: For each critical sampling point in parenteral area prepare a trend report once in a week for following critical parameters. 1. Microbial count 2. Chemical analysis :pH, Conductivity, Total organic carbon. 5.3 Plot the statistical control graph for all above critical parameters. Indicate alert and action level in graph. 5.4 The water system is consider as satisfactory for its quality of output, If results are within the acceptance. 5.5 Conclude the trend analysis from the graphical values for consistent quality of purified water and W.F.I. Keep track of results and indicate high lighted in case reaches to Alert or Action level. 5.6 Sign the trend report, get checked by Q.C. Incharge and approved by Q.A. Related: Water for Injection System Validation Protocol 6.0 ABBREVIATIONS: 6.1 6.2 6.3 6.4 SOP = Standard Operating Procedure Q.A. = Quality Assurance Q.C. = Quality Control W.F.I = Water for injection converted by Web2PDFConvert.com . Comment as: Google Account Publish Preview ABOUT THE AUTHOR Ankur Choudhary is experienced in pharmaceutical. Ensure a process for quality molds & parts Further Readings:. 8. 7. a widely-read pharmaceutical blog since 2008. 1. 3. 5. author and founder of Pharmaceutical Guidelines.com m ..com Follow 0 Get Free Updates Enter your email here. 4. 10.. Shelf Life Estimation of Pharmaceutical Products Forced Degradation Study in Pharmaceutical Stability SOP for Cleaning of EPD Collator Machine with Strip Packing Machine Line SOP for Cleaning of Semi-Automatic Cartoning Machine SOP for Cleaning of Mini Roll Compactor SOP for Cleaning of Tablet Counter SOP for Cleaning of Semi Auto Induction Cap Sealing Machine Calculation for Determination of Weighing Range of Balances Understanding the Process of Finding Impurities in Pharmaceutical Analysis Significant Change in Pharmaceutical Stability Testing ► Injection W r i t P o s t ► USP Water e Y a ► Pharmaceutical o u r C o m V m a e ► Sampling Methods l n u a b l e C o m t Enter your comment. 2. Join converted by Web2PDFConvert. 9.. Email: [email protected] Device Validation Minimize wasted time &cost. 6. 821 followers Ads by Yahoo Pharmaguideline Mobile App CGMP ISO USFDA WHO FOLLOW CONTACT US PHARMA WIDGETS MOBILE APPS © 2014 All rights reserved to Ankur Choudhary and data may not be reproduced on other websites. converted by Web2PDFConvert.com . Designed by Pharmaceutical Guidelines. Pharmaguideline 13 videos Subscribe 442 Follow @pharmaguideline 1.Join to Get News Updates Pharmaguideline Like 20.481 people like Pharmaguideline.