testing of gel-based pharmaceutical products.

3. Responsibilities

• Production Department: Ensures accurate and timely completion of BMRs.
• Quality Assurance (QA): Performs detailed review of all entries and supporting documentation.
• Head – QA: Final reviewer for batch release authorization.

4. Accountability

The QA Head is accountable for ensuring that only compliant and accurately reviewed batch records proceed to batch disposition.

5. Procedure

5.1 Preliminary Collection and Organization

1. Collect the completed BMR from the production department once the batch is manufactured and packaged.
2. Ensure all associated IPC records, cleaning logs, line clearance forms, and deviation reports are attached.

5.2 Document Review

1. Check for completeness:
   • All fields filled and signed
   • No overwriting without proper correction
   • All required forms and checklists are attached
2. Verify key production parameters like batch size, yield, pH, viscosity, homogenization time, and temperature logs.
3. Review any deviations, change controls, or incident reports attached to the batch.

5.3 Cross-Verification with Specifications

1. Compare in-process and final product parameters with product specifications.
2. Check for any trends or potential batch-to-batch inconsistencies.
3. Confirm testing reports from QC are attached and match acceptance criteria.

5.4 Corrections and Clarifications

1. Highlight discrepancies, missing signatures, or unrecorded steps in a BMR Review Checklist (Annexure-1).
2. Return BMR to Production for clarification if discrepancies are noted.
3. Maintain a copy of the communication trail if corrections are made post-batch completion.

5.5 Final Review and Approval

1. After corrections, QA shall perform a second review to ensure completeness.
2. QA Head shall sign the BMR approval section indicating the batch is compliant.
3. Forward approved BMR for final disposition or batch release by Quality Head.

6. Abbreviations

• BMR: Batch Manufacturing Record
• IPC: In-Process Control
• QA: Quality Assurance
• QC: Quality Control

7. Documents

1. Batch Manufacturing Record
2. BMR Review Checklist – Annexure-1
3. In-Process Control Record
4. Line Clearance Checklist

8. References

• WHO TRS No. 986 Annex 2 – Good Manufacturing Practices
• ICH Q10 – Pharmaceutical Quality System

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: BMR Review Checklist

Review Point	Yes/No	Remarks
All BMR fields completed
Signatures present for all steps
All IPC and QC results attached
No deviations unaccounted
Yield within acceptable range
Corrections justified and initialed
Final QA review complete

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Updated review structure and included checklist format	GMP Alignment	QA Head