| Receipt and Analysis of Finished Product |
1.0 OBJECTIVE 1.1 To lay down the procedure for receipt and analysis of finished product in quality control lab. 2.0 SCOPE 2.1 This SOP is applicable for receipt and analysis of finished product in quality control department. 3.0 RESPONSIBILITY 3.1 QC – Chemist / Officer / Executive 4.0 ACCOUNTABILITY 4.1 Head-QC 5.0 PROCEDURE 5.1 Receiving Procedure: 5.1.1 Q.A. persons should handover the finished product’s sample to In-process quality control along with the analytical request sheet for chemical or microbiological testing. 5.1.2 Officer/Executive QC should enter the details like Batch No., Mfg. Date, Exp. Date, Batch Size etc. in the finished product inward register Format XXX and allot the A. R. Number. 5.1.3 Officer/Executive QC should sign in the register of Q.A. for receiving of all samples and put all the samples in to a plastic tray which should be kept for samples of different stages before analysis. 5.1.4 Microbiologist should also collect sample from the tray of received sample, and make entry in to a sample received for microbiological tests. 5.2 Testing procedure: 5.2.1 Microbiologist should also collect sample from the tray of received sample, and make entry in to a sample received for microbiological tests. 5.2.2 Executive/Assistant Manager Q.C. should distribute the samples for analysis as per SOP No.: XXX as per the training provided to person for testing. 5.2.3 Carry out the analysis as per current version of standard test procedure and standard test specification/IP/BP/USP and fill the details of analysis in worksheet and attach the supporting documents with it with related intimation also. 5.2.4 If any results found during any type of testing, Analyst should inform Manager Q.C. immediately. 5.2.5 Analyst should check before starting the analysis that any test going to outside / our other Unit or not. If any test not possible to analyze this plant, analyst should prepare intimation for sample send to outside with an entry of outside sample sending record register. 5.2.6 After completion of satisfactory analysis of any finished product, analyst will prepare a worksheet of the same as well as release note for the same and arrange to prepare a Certificate of analysis. 5.2.7 After preparation of COA of the any finished product, Q.C. Manager will sign it and hand over to Q.A. Dept with a receiving in register of “COA handover to Q.A. Dept” as per attached format XXX. |
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