covers the responsibilities, documentation, review process, and approval hierarchy from production through Quality Assurance (QA).

3. Responsibilities

• Production Officer: Ensure all fields in BMR are duly filled, signed, and verified during manufacturing activities.
• QA Reviewer: Perform thorough BMR review post-manufacture and identify deviations, omissions, or errors.
• QA Manager: Approve BMR after verification and confirm batch release readiness.
• QC Analyst: Attach all relevant analytical data, including Certificate of Analysis (CoA), to the BMR.

4. Accountability

The Head of Quality Assurance is accountable for ensuring compliance with the BMR review procedure and that no batch is released without BMR approval.

5. Procedure

5.1 BMR Preparation During Manufacturing

1. The Production department shall fill out the BMR in real-time, using indelible ink, without overwriting.
2. Entries must be made immediately after each activity step is completed.
3. All sections must be signed and dated by the responsible personnel and verified by production supervisory staff.
4. Attach all associated documents including raw material requisition, process flow diagrams, in-process test results, equipment usage logs, and deviation reports.

5.2 Handover to QA

1. After completion of batch manufacturing, the Production Officer shall hand over the BMR to QA.
2. QA must log the date and time of BMR receipt in the “BMR Receipt Register” (Annexure-1).

5.3 Preliminary QA Review

1. Check the following:
   • Batch number and product name match the production plan
   • All required fields are filled, signed, and dated
   • No overwriting or unauthorized corrections exist
   • All in-process checks are documented
   • Logbook references match the entries

5.4 Detailed QA Review Checklist

1. Verify the following:
   • Raw materials were issued from approved stock and used within their shelf life
   • Equipment was cleaned, calibrated, and released before use
   • Critical process parameters are documented and fall within permissible ranges
   • Yield and reconciliation calculations are correct
   • Any deviations are recorded and closed with approved CAPA
   • Analytical results match the specifications
2. Record observations in the “BMR Review Checklist” (Annexure-2).

5.5 Handling Deviations in BMR

1. If entries are missing or incorrect, raise a BMR discrepancy form (Annexure-3).
2. Discrepancy must be resolved before final approval.
3. Corrective entries must be endorsed with initials, date, and explanation — overwriting is not allowed.

5.6 BMR Approval and Archival

1. After all corrections, the QA Reviewer shall sign the BMR review section.
2. QA Manager shall perform a final review and approve the batch by signing the “Approved for Release” page.
3. The approved BMR is handed to Document Control for archiving and scanned for electronic backup.

5.7 Batch Release Decision

1. Only after BMR is reviewed, signed, and supported by:
   • CoA
   • Deviation closure reports
   • In-process and final QC reports
2. The batch release decision shall be documented and batch disposition updated in ERP/MIS system.

5.8 Retention of BMRs

1. All BMRs shall be retained in a secured archive room for a minimum of 5 years or as per product shelf life.
2. Electronic BMRs (eBMRs) shall be password protected and have limited access under QA control.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• CAPA: Corrective and Preventive Action
• ERP: Enterprise Resource Planning

7. Documents

1. BMR Receipt Register (Annexure-1)
2. BMR Review Checklist (Annexure-2)
3. BMR Discrepancy Form (Annexure-3)
4. Final BMR Approval Record
5. Batch Release Status Sheet

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.188 – Batch Production and Control Records
• EU GMP Guidelines – Chapter 4: Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: BMR Receipt Register

Date	Batch No.	Product Name	Received By	QA Initials
13/04/2025	BCH/APR/001	API-Z	Rajesh Kumar	SN

Annexure-2: BMR Review Checklist

Review Parameter	Yes/No	Comments
Raw Material Traceability Verified	Yes	All CoAs Attached
Yield Calculation Accurate	Yes	Within limits
All Pages Signed	No	Page 12 signature missing

Annexure-3: BMR Discrepancy Form

Date	Batch No.	Discrepancy Observed	Corrective Action	Approved By
13/04/2025	BCH/APR/001	Omitted yield entry	Updated by Supervisor	QA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial version	New implementation	QA Head
14/04/2025	2.0	Added review checklist and ERP integration	Compliance upgrade	QA Head