1.0 OBJECTIVE:To lay down the procedure for testing & release/rejection of Finished product.
2.0 SCOPE:This SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY:Quality Control Supervisor
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance
5.0 PROCEDURE:5.1 QA Personnel shall collect the Finished Product Sample and hand it over to QC chemist for analysis as per Finished Product Specification and the same shall be recorded in control sample register.
5.2 Proper records shall be maintained for the same showing the details of the sample, the test protocol applied, the results obtained, and the decision regarding acceptance/Rejection of the material/batch.
5.3 The details of the sample collected shall be entered into the entry register maintained separately for finished goods.
5.4 A Report of the Test Protocol applied and results obtained shall be maintained in a proper format wherein the Calculations/work sheet shall be included. Two copies of Test reports shall be made for Finished product. One copy shall be attached in BMR and the other copy shall be maintained in QC department.
5.5 If the sample is found to be complying to the test specifications, the same shall be released. If the same does not comply, the material shall be rejected.
5.6 After Approval of a Batch, Proper Control number for the same shall be allocated by QC department and the same shall be maintained in the Finished Product Register. “Release” labels shall be given to QA Personnel and the same shall be attached in BMR and on pallets holding the batch in Under test area in BSR.
5.7 QC Chemist shall prepare COA/Finished Product Report and the copy of the same shall be given to QA Personnel for attaching in BMR.
5.8 After Q.C Release, QA Personnel shall give “BSR Release” tag to BSR department for Further Dispatch and Distribution and the copy of the same shall be attached in BMR for future references.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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