Approval / Rejection of In-process material / Finished

1.0 OBJECTIVE
To lay down a procedure for testing and release of in process materials and finished products for the manufacturing and release of Products.
2.0 SCOPE
This SOP Covers the procedure for Approval / Rejection of In process material / Finished Product.and this is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Quality Control Chemist.
4.0 ACCOUNTABILITY
Department head
5.0 PROCEDURE
5.1 Sample the in-process material / finished product as per the SOP on “Sampling of in-process material / finished products” SOP No. xxxxx
5.2 On receipt of in-process material / finished product samples in Quality Control Department along with analysis request sheet, Chemist shall check the following :
5.2.1 Label details on the samples to match with those on the analysis request sheet.
5.2.2 In case of any discrepancies, clarify with Department head.
5.2.3 Ensure that the samples and documents are placed properly in trays meant for the purpose
5.3. Quality Control chemist after receiving the sample, enter relevant details like sap
order number in SAP . After finding A.R.No in sap. Enter the A.R.No in in process
inward register
5.4 The Chemist shall take up the sample for analysis as per current specifications and analytical methods and enter the results in the analytical report calculation sheet (Any specific non-conformance shall be brought to the attention of Department head)
5.5 In process sample clearance : Chemist will also enter the relevant details in Process control Inward register and get the completed document duly signed checked by a second chemist or Executive. Chemist should submit the complete Analytical report duly signed to Department Head for Approval.
5.5.1 Chemist will send the production copy to production and files the Quality Control copy.
5.5.2 Approved / Rejected labels will be prepared.
5.5.3 Quality Control Chemist shall sign the approved / rejected labels and match the details like name of the material, 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 ‘UNDER TEST’ label is completely overlapped
5.5.4 The amount of sample left over after analysis will be destroyed as per the laid down procedures.
5.6 Finished Product Clearance : Chemist will also enter the relevant details in Process control Inward register and get the completed document duly signed checked by a second chemist or Executive. Chemist should submit the complete Analytical report duly signed to Department Head for Approval.
5.6.1 Department head shall check the analytical data and compliance of material as per specifications and shall clear the batch if it complies. In case the product does not conform to specifications, the chemist shall reject the batch after informing to GM-Quality Assurance.
5.6.2 Department head shall certify the approval / rejection of the batch by signing the documents.
5.6.3 Approved / Rejected labels will be prepared.
5.6.4 Quality Control Chemist shall sign the approved / rejected labels and match the details like name of the material, 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 ‘UNDER TEST’ label is completely overlapped.
5.6.5 The amount of sample left over after analysis will be destroyed as per the laid down procedures.