| Receipt, Analysis and Releasing of Intermediate Product |
1.0 OBJECTIVE 1.1 To lay down the procedure for receipt, analysis and releasing of intermediate product in quality control department. 2.0 SCOPE 2.1 This SOP is applicable for receipt, analysis and releasing of intermediate 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 intermediate sample to In-process quality control along with the analytical request sheet for chemical or microbiological testing. 5.1.2 Executive QC should enter the details like Batch No., Mfg. Date, Exp. Date, Batch Size etc in the Intermediate sample inward register in different stage like granules, un-coated tablet, coated tablet etc. 5.1.3 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 Assistant Manager Q.C. should distribute the Samples for analysis as per SOP No.: XXX as per the training provided to person for testing. 5.2.2 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 related intimation also. 5.2.3 If any results found during any type of testing, analyst should inform Manager Q.C. immediately. 5.2.4 Analyst should check before starting the analysis that any test going to out side / our Unit-II 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. 5.2.5 After completion of satisfactory analysis of any intermediate sample, analyst will prepare a worksheet of the same as well as release note of the same and arrange to send it Q.A. Department. 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. |
