Standard Operating Procedure for Review of Batch Manufacturing Records
| Department | Sterile Injectable Manufacturing |
|---|---|
| SOP No. | SOP/SIM/081/2025 |
| Supersedes | SOP/SIM/081/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 18/06/2025 |
| Effective Date | 20/06/2025 |
| Review Date | 18/06/2026 |
1. Purpose
This SOP defines the systematic approach to reviewing Batch Manufacturing Records (BMR) in sterile injectable manufacturing to ensure completeness, accuracy, and compliance with GMP regulations.
2. Scope
This procedure applies to Quality Assurance personnel responsible for reviewing BMRs for sterile injectable products prior
to batch release.
3. Responsibilities
- Production Officer: Responsible for timely and accurate completion of BMR entries.
- QA Officer: Responsible for thorough review of BMR against executed activities and documentation.
- Head QA: Final reviewer and approver for BMR and batch release recommendation.
4. Accountability
The Head of Quality Assurance is accountable for ensuring all BMRs are thoroughly reviewed and meet compliance standards prior to batch disposition.
5. Procedure
5.1 Receipt and Initial Check
- Production hands over the completed BMR with all attachments (IPC results, raw material tags, cleaning records, etc.) to QA.
- QA checks for completeness using a BMR checklist (Annexure-1).
5.2 Detailed Page-by-Page Review
- Verify material issuance, batch number traceability, and reconciliation entries.
- Cross-check IPC values with IPC reports and QA sign-offs.
- Ensure cleaning records, equipment usage logs, and calibration status are attached and filled.
- Ensure signatures, timestamps, and data entries follow ALCOA+ principles.
5.3 Critical Observations
- Identify missing entries, overwriting, unapproved corrections, or gaps.
- Record observations in the BMR Review Observation Sheet (Annexure-2).
- Communicate observations to production for clarification or CAPA (Corrective and Preventive Action).
5.4 Documentation Corrections
- Allow corrections only with justification, sign, and date.
- Ensure no use of whitener or unauthorized modification in GMP documents.
5.5 Final QA Review Summary
- Summarize BMR review outcome in the BMR Review Summary Log (Annexure-3).
- Only approved BMRs shall proceed to batch release review.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- IPC: In-Process Control
- GMP: Good Manufacturing Practices
- CAPA: Corrective and Preventive Action
- ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
7. Documents
- BMR Review Checklist – Annexure-1
- BMR Review Observation Sheet – Annexure-2
- BMR Review Summary Log – Annexure-3
8. References
- WHO TRS 986 Annex 2: GMP for Sterile Pharmaceutical Products
- 21 CFR Part 211 – Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q10 – Pharmaceutical Quality System
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Manufacturing Executive | QA Executive | Head QA |
| Department | Production | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: BMR Review Checklist
| Item | Status | Remarks |
|---|---|---|
| All pages present and numbered | Yes | Verified |
| IPC entries signed | Yes | Complete |
Annexure-2: BMR Review Observation Sheet
| Observation No. | Description | Action Taken | Reviewer | Date |
|---|---|---|---|---|
| OBS-041 | Missing pH value in IPC | Updated by operator | Sunita Reddy | 18/06/2025 |
Annexure-3: BMR Review Summary Log
| Batch No. | Reviewed By | Review Date | Outcome | Remarks |
|---|---|---|---|---|
| INJ-8804 | Rajesh Kumar | 18/06/2025 | Accepted | No major discrepancies |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial release | New SOP | QA Head |
| 18/06/2025 | 2.0 | Updated checklist and ALCOA+ alignment | Compliance enhancement | QA Head |