SOP for Batch Release for Finished Goods

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 the finished Product Release Report (FRR) (Annexure – 1) from the Production Department, the 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 the quantities mentioned in the 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 the 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, the QA Officer shall sign the FRR with the date and submit it to the 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 a date.
• A copy of the FRR shall be filed with the respective BPR.

ANNEXURE

Annexure – 1: Finished Product Release Report (FRR)

REVISION HISTORY

Nil

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