to health authorities if required.

4. Accountability

The QA Manager is accountable for final disposition decisions and ensuring compliance with recall and return procedures.

5. Procedure

5.1 Receipt and Quarantine

1. Receive returned gel products at the designated return gate with accompanying documentation.
2. Inspect the packaging for tampering or transit damage.
3. Label with “Returned Goods – Quarantine” tag and store in a segregated quarantine area.
4. Record details in the Returned Goods Logbook – Annexure-1.

5.2 Evaluation and Investigation

1. QA initiates investigation using Return Evaluation Form – Annexure-2.
2. QC samples product if there are indications of stability, contamination, or identity issues.
3. Compare returned batch against the original COA and stability data.
4. Perform trend analysis if similar returns have occurred previously.

5.3 Decision on Disposition

1. Evaluate the root cause (logistic, handling, formulation issue, etc.).
2. If product is unopened, uncompromised, and within expiry: consider re-evaluation and relabeling as per QA discretion.
3. If compromised or tampered: route for destruction with QA approval.
4. Complete Return Disposition Form – Annexure-3 with justification and signature.

5.4 Destruction Procedure

1. Shift materials to the destruction area under QA supervision.
2. Conduct destruction as per SOP for Product Destruction using incineration or chemical neutralization.
3. Record in Destruction Logbook and retain signed destruction certificate – Annexure-4.

5.5 Documentation and Reporting

1. Update batch record with returned quantity and reason for return.
2. Include summary in Annual Product Quality Review (APQR).
3. Report serious quality failures to regulatory bodies if applicable (e.g., CDSCO, US FDA).

6. Abbreviations

• QA: Quality Assurance
• QC: Quality Control
• APQR: Annual Product Quality Review
• CDSCO: Central Drugs Standard Control Organization

7. Documents

1. Returned Goods Logbook – Annexure-1
2. Return Evaluation Form – Annexure-2
3. Return Disposition Form – Annexure-3
4. Destruction Certificate – Annexure-4

8. References

• WHO TRS 986 Annex 3: Good Manufacturing Practices
• 21 CFR Part 211.204: Returned Drug Products
• Schedule M: Good Manufacturing Practices for Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Warehouse Supervisor	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Returned Goods Logbook

Date	Product Name	Batch No.	Quantity	Reason for Return

Annexure-2: Return Evaluation Form

Batch No.
Customer Complaint Ref
Evaluation Summary
QC Remarks
QA Decision

Annexure-3: Return Disposition Form

Batch No.
Disposition Type	Rework / Destroy / Relabel
Justification
Approved By

Annexure-4: Destruction Certificate

Date
Batch No.
Quantity Destroyed
Method Used
Signature of QA Witness

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/03/2022	1.0	Initial version	New SOP	QA Manager
09/06/2025	2.0	Updated with annexures and CDSCO alignment	Regulatory audit findings	QA Manager