SOP for Testing, Release or Rejection of Finished Product : Pharmaguideline

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SOP for Testing, Release or Rejection of Finished Product

Standard operating procedure to analyze, release or reject the finished product after analysis.


To lay down the procedure for testing & release/rejection of the finished product.


This SOP shall be applicable to Quality Control Dept.


Quality Control Supervisor


Sr. Manager Quality Assurance


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/ worksheet shall be included. Two copies of Test reports shall be made for the 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.


6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 Dept.: Department
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