Monday, December 8, 2008


To lay down a procedure for testing and release of raw materials for the manufacturing of Products.
This SOP covers the procedure for Approval/ Rejection of Raw material and this is applicable to Quality Control Department
Quality Control Chemist.
Department head
5.1 Sample the raw materials as per the SOP on “Sampling of Raw Materials” SOP No. xxxxx
5.2 On receipt of raw material samples in Quality Control Department along with GRN, COA of supplier (if available) and Sampler’s remarks sheet, the Chemist shall check the following :
5.2.1 Label details on the samples to match with those on GRN and COA of supplier (if available)
5.2.2 Sampler’s remarks Sheet
5.2.3 In case of any discrepancies, clarify with Department head
5.3. Ensure that the samples and documents are placed properly in trays meant for the purpose
5.4 The Chemist shall take up the sample for analysis as per current specifications and Analytical Methods. Any specific non-conformance shall be brought to the attention of Q A and enter the results in the analytical report. Immediately on completion of the analysis, submit the completed Analytical report duly signed to Department head.
5.5 Department head shall check the analytical data and compliance of material as per specifications and shall clear the material if it complies. In case the material does not conform to specifications, reject the material after informing to GM-Quality Assurance.
5.6 Department head / GM- Quality Assurance shall certify the approval / rejection of raw material by signing the documents.
5.7 Approved / Rejected labels will be prepared with the help of computer as per laid down procedure
5.8 Quality Control Chemist shall sign the approved / rejected labels. Match the details like name of the material, GRN No., batch number on the container label with details on approved / rejected label. Affix the approved / rejected label on each container in such a manner that the word “UNDER TEST ” on the label is completely overlapped and the name and GRN No. on the “UNDER TEST” labels are visible.
5.9 Take care that the name and GRN number on the under test label are visible.
6.0 After finishing the Analysis, enter all the results in SAP . & take usage decision for approved / Rejected. Also, take, GRN copy from SAP. Finally, after approval / Rejected in SAP, Paste the Approved / Rejected Labels on the under test label of the container.
6.1 The amount of sample left over after analysis will be destroyed as per the laid down procedures.

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