department and ready for batch release to market or further distribution.

3. Responsibilities

• Quality Control Department: Ensure all testing has been performed and documented for the batch.
• Quality Assurance Department: Review all batch-related documentation and testing data before approving the final batch release.
• Warehouse Department: Store the released products separately from quarantined or rejected goods.

4. Accountability

The Head – Quality Assurance is accountable for the final release of gel batches after satisfactory review.

5. Procedure

5.1 Verification of Testing Completion

1. QC personnel must confirm that all required quality control tests (e.g., assay, pH, viscosity, microbial testing) have been completed.
2. All test results must be within predefined specifications.
3. Laboratory reports must be signed and approved by authorized QC personnel.

5.2 Documentation Review

1. QA personnel will review the following documents:
   • Batch Manufacturing Record (BMR)
   • Packaging Record
   • Sampling Log
   • QC Test Reports
   • Deviation Reports, if any
2. Ensure that:
   • No critical deviations remain open
   • All corrective and preventive actions (CAPAs), if any, have been completed
   • All signatures and entries are complete and verified

5.3 Final Release Approval

1. QA Head shall provide formal written approval using the Final Batch Release Authorization (Annexure-1).
2. Released status shall be recorded in the Batch Release Logbook (Annexure-2).
3. Release status tags shall be affixed to the batch storage location (green tag indicating ‘Released’).

5.4 System Update and Communication

1. QA must update the ERP/MIS system indicating the release of the batch.
2. Notify Warehouse and Distribution teams for further logistics and planning.

5.5 Rejection and Hold

1. If any QC result is out-of-specification (OOS) or documentation is incomplete, QA shall place the batch on hold.
2. Reject tags must be affixed to the concerned batch if deemed unfit for release (red tag).
3. Initiate investigation and deviation report as applicable.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• OOS: Out of Specification

7. Documents

1. Final Batch Release Authorization – Annexure-1
2. Batch Release Logbook – Annexure-2
3. Batch Manufacturing Record (BMR)
4. QC Reports

8. References

• WHO TRS 986 – Annex 2: GMP Guidelines
• FDA 21 CFR Part 211 – Subpart J: Records and Reports
• 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	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Final Batch Release Authorization

Batch No.
Product Name
Date of Packaging
QC Status	Pass / Fail
QA Review Complete	Yes / No
Released By (QA Head)
Release Date
Remarks

Annexure-2: Batch Release Logbook

Date	Batch No.	Product Name	Released By	QC Status	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial SOP released	New documentation	QA Head
02/06/2025	2.0	Format updated and annexures added	Annual revision	QA Head