SOP For Release of Finished Products
OBJECTIVE :
To lay down the procedure for QA release of Finished Product for distribution.
RESPONSIBILITY :
Quality Assurance Officer.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE :
After receiving Finished Product Release Report (FRR) (Annexure – 1) from Production Department, QA – Officer shall check the following.
All the details such as Product name, Batch number, Packaging details, Quantity packed in each type of packing, etc., are duly entered in FRR.
Ensure that BPR is complete, reviewed and approved by Quality Assurance.
Check that the total batch quantity is tallying with that of quantities mentioned in Batch Production Record (BPR) and FRR.
Check that all the containers / shippers are properly sealed.
Compare the product details on FRR against product details on shippers / containers and ensure that they are same.
Check that all the shippers / containers have Product labels in conformance with approved product label attached with BPR.
Check that all the shippers / containers have handling instructions.
If all the above mentioned points are found satisfactory, QA Officer shall sign the FRR with date and submit it to Head of Quality Assurance or his designee for approval.
Head of Quality Assurance or his designee shall release the product for distribution by signing the FRR with date.
A copy of the FRR shall be filed with respective BPR.
Forms and Records (Annexures)
Not Applicable
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control, engineering
- History
Date Revision Number Reason for Revision – 00 New SOP
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