SOP for Approval and Release of Finished Goods

OBJECTIVE

To lay down the procedure to release the finished products for sales or distribution after reviewing essential information such as production conditions, in-process checks, examination of manufacturing and analytical documents and the conformity of the product to their release specification

SCOPE

This procedure is applicable for finished goods product manufactured in the Production Formulation department of Pharmainfo Ltd.

RESPONSIBILITY

Executive QA shall be responsible for the preparation and compliance with the SOP.

QA-Head shall be responsible for checking and compliance of the procedure.

ACCOUNTABILITY

Quality Assurance– Head shall be accountable for the proper implementation of the SOP.

PROCEDURE

• On completion of the batch packaging operation. Officer – Production shall prepare the transfer slip for transferring the finished goods to the Finished goods Store Room.
• Quality Assurance – Executive/officer shall check the transfer slip for correct product name, strength, batch number, Manufacturing & Expiry Date, and pack size according to the Batch Manufacturing record.
• Quality Assurance – Executive/officer shall check that the BMR is completed and signed in all aspects.
• Check that control/stability samples are collected and recorded in the BMR.
• Ensure that the finished product sample from the batch is collected and sent to the Quality Control Laboratory for testing.
• Check the batch record for the presence of all the pages, Raw Material tag, Packing Material issue, In Process Quality Assurance (IPQA) results, and approved packing material specimen.
• Check the batch reconciliation and ensure that yields at various stages specified in BMR are within the specified limits.

• Ensure that if any deviation from the specified limit for yield is investigated, and the yield deviation report is approved by the Head of the concerned Department and the Head – Quality Assurance is attached in the BMR
• Check that all the attachments are filed in sequence as mentioned in the checklist.

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1. Check the reconciliation of packaging material.
2. Ensure that any variance more than the acceptance limit set in the BMR shall be investigated, and a Photocopy of the report, approved by the Head of the concerned department and the Head – Quality Assurance, shall be attached in the BMR.
3. Ensure that any deviations from written procedures are documented, and a photocopy of the process deviation report duly approved by the Head –Quality Assurance is attached in the BMR.
4. Check and verify the Batch Manufacturing and Packing Record as per the checklist given in BMR (Refer Annexure – 1).
5. If entry or any data is found incomplete or the signature is missing at any place, get it correct and ensure that it is filled up.
6. Ensure that any deviation reported during In-process checks are rectified and recorded, also the corrective actions are authorized of the Head- Quality Assurance.
7. In case of any discrepancies, the Head - Quality Assurance and the concerned Production Head shall be informed for corrective action. Do not approve the transfer slip till the discrepancies are rectified.
8. Check quantity ready for transfer is stacked properly on pallets.
9. Check for the correct batch coding on the shipper to match with the Batch Manufacturing Record.
10. Physically verify the Finished Goods Quantity against the transfer slip Quantity. In case of a Loose Box, open the box and verify the quantity, if a Discrepancy is observed, inform to Head Production and get it rectified and clear the transfer slip by signing in the column provided for Quality Assurance and hand over to the Finished Goods store room and attach one copy with the BMR.
11. Handover completed batch document to Head – Quality Assurance or his designee.
12. Head – QC shall check the complete analytical report with Certificate Of Analysis (COA) and ensure that the report is consistent with the approved release specification of the product. Handover the Certificate of Analysis to Quality Assurance to attach with BMR.
13. If all documents are found satisfactory, then Head – Quality Assurance or his designee shall approve the Batch Document.
14. Quality Assurance – Officer / Executive shall prepare the Batch Release Note (Refer Annexure – 2).
15. Head – Quality Assurance or his designee shall approve the Batch Release Note and hand over to the Finished Goods store room for sale or distribution of Finished Goods. One Photocopy of the Batch Release Note shall be attached to BMR.
16. QA head or his designee shall release the batch.

ABBREVIATIONS

Nil

REFERENCES

In-house

DISTRIBUTION LIST

Control copy of SOP shall be distributed to Quality Assurance, Production Formulation, Production Bulk, Quality Control, and IPQA.

ANNEXURES

Format for document checklist in Batch Manufacturing Record

Batch Release Note 

REVISION HISTORY

Nil

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