Procedure for Batch Manufacturing Record Review
| Department | Quality Assurance (QA)/Quality Control (QC)/Production |
|---|---|
| SOP No. | SOP/Ointment/083 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for reviewing Batch Manufacturing Records (BMR) to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and product quality standards.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Production departments responsible for preparing, reviewing, and approving BMRs in ointment manufacturing.
3. Responsibilities
- Production Operator: Completes batch records and ensures accurate documentation of manufacturing activities.
- Production Supervisor: Verifies that records are properly filled out before submitting them to QA.
- Quality Control (QC) Analyst: Ensures all analytical results and test reports are documented correctly.
- Quality Assurance (QA) Officer: Reviews the BMR for completeness, accuracy, and compliance with specifications.
- QA Manager: Approves the final BMR for batch release.
4. Accountability
The QA and Production Managers are accountable for ensuring that BMRs are reviewed accurately and meet regulatory and GMP requirements before batch release.
5. Procedure
5.1 BMR Documentation Review
- Ensure that all pages of the BMR are included and properly numbered.
- Verify that the batch number, product name, and manufacturing date are correctly recorded.
- Ensure that all entries are legible and signed by authorized personnel.
- Confirm that corrections (if any) are made following proper documentation practices (single-line strike-through, initials, date).
5.2 Process and Equipment Review
- Verify that the correct equipment was used as per the master batch record.
- Ensure that cleaning and calibration records for the equipment are documented.
- Check that in-process control (IPC) tests were conducted at specified intervals.
5.3 Raw Material and Component Verification
- Ensure that all raw materials used are from approved sources.
- Verify that batch numbers of raw materials match the materials listed in the BMR.
- Check that material dispensing was performed as per the predefined quantity.
5.4 In-Process Quality Control (IPQC) Checks
- Verify that required in-process checks (e.g., pH, viscosity, temperature) are documented.
- Ensure that test results fall within the specified acceptance criteria.
- Confirm that deviations (if any) are documented and justified.
5.5 Packaging and Labeling Review
- Check that the correct packaging materials were used.
- Verify that label details (batch number, expiry date) are correct.
- Ensure that reconciliation of packaging materials is documented.
5.6 Deviations and Corrective Actions
- Identify and review any deviations recorded in the BMR.
- Ensure corrective actions taken are documented and approved.
- Confirm that deviation reports are closed before batch release.
5.7 Final Approval and Batch Release
- Ensure all sections of the BMR are completed and signed by authorized personnel.
- QA Manager must review and approve the final BMR.
- Once approved, the batch may be released for distribution.
5.8 Documentation
- Maintain copies of the reviewed and approved BMR for future audits.
- Record batch release details in the Batch Record Review Log.
- Ensure records are stored securely and accessible for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
- IPQC – In-Process Quality Control
7. Documents
- Batch Record Review Log (Annexure-1)
- Batch Release Approval Form (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- USP <1163> – Good Documentation Practices
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Record Review Log
| Date | Batch Number | Product Name | BMR Completed | Deviations Noted | Final Status | Reviewed By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Ointment A | Yes | No | Approved | QA Officer |
| 02/02/2025 | OINT-102 | Ointment B | Yes | Yes | Approved with Deviation | QA Officer |
Annexure-2: Batch Release Approval Form
| Date | Batch Number | Product Name | Final Review Status | Approved By |
|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Ointment A | Approved | QA Head |
| 02/02/2025 | OINT-102 | Ointment B | Approved with Deviation | QA Head |