Standard Operating Procedure for Batch Record Documentation and Verification in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/035/2025 |
| Supersedes | SOP/API/035/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a clear and GMP-compliant procedure for the proper documentation and verification of Batch Manufacturing Records (BMRs) during API production, ensuring data integrity, traceability, and regulatory compliance.
2. Scope
This SOP applies to all BMRs generated during the manufacturing of APIs, including entries made by production, in-process control (IPC), and QA personnel.
3. Responsibilities
- Production Personnel: Record batch data promptly and legibly in the BMR.
- QA Reviewer: Verify completeness, correctness, and compliance of the documentation.
- Supervisor: Ensure timely and accurate data entry and report deviations immediately.
4. Accountability
The Production Head is accountable for accurate documentation, and the QA Head is responsible for final review and approval of BMRs for batch disposition.
5. Procedure
5.1 General Guidelines
- Only black or blue indelible ink shall be used for manual entries.
- Entries shall be made at the time the activity is performed (real-time recording).
- Each entry must include date, time (where required), signature, and designation of the person performing the task.
- Overwriting is prohibited. In case of errors, strike through the incorrect entry with a single line, record the correction, and initial with date.
- Do not leave blank fields. If a section is not applicable, write “NA” with justification if needed.
5.2 Data Entry Process
- Record all input materials with batch numbers, quantity used, and weighment time in the BMR.
- Document process parameters such as temperature, pH, agitation speed, pressure, and hold time as per defined intervals or batch stages.
- In-process testing data (e.g., clarity, reaction completion) should be entered by the chemist or IPC officer at the time of sampling.
- Ensure each process step is signed off by the operator and checked by the supervisor.
5.3 Review and Verification
- QA shall review BMR entries for:
- Completeness of information
- Correct sequence of events
- Deviations or corrections made
- Authorization and verification signatures
- Identify and highlight any missing data or discrepancies using the “BMR Verification Checklist” (Annexure-1).
- Request corrections through deviation/CAPA route where required.
5.4 Batch Record Reconciliation and Archiving
- Ensure reconciliation of all raw materials, intermediates, and yields at each step.
- QA signs final approval section of the BMR post-review.
- Label and archive the reviewed BMR in the QA documentation room with controlled access.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- IPC: In-Process Control
- CAPA: Corrective and Preventive Action
7. Documents
- BMR Verification Checklist (Annexure-1)
- Deviation/CAPA Form (Annexure-2)
- BMR Issue and Retrieval Log (Annexure-3)
8. References
- ICH Q7 – GMP for Active Pharmaceutical Ingredients
- 21 CFR Part 211 – Subpart J: Records and Reports
- WHO GMP – Documentation Guidelines
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 Verification Checklist
| Item | Checked (Y/N) | Remarks |
|---|---|---|
| Material Entries Complete | Y | Verified |
| Signatures Present | Y | All roles signed |
| Corrections Marked Properly | Y | No overwriting |
Annexure-2: Deviation/CAPA Form
| Date | Deviation ID | Brief Description | CAPA Initiated | Status |
|---|---|---|---|---|
| 13/04/2025 | DEV-035-25 | Missing pH entry at stage-3 | Yes | Closed |
Annexure-3: BMR Issue and Retrieval Log
| Date Issued | Issued To | Batch No. | Date Returned | Returned By |
|---|---|---|---|---|
| 10/04/2025 | Production | API-202504 | 13/04/2025 | QA |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | New SOP Implementation | QA Head |
| 13/04/2025 | 2.0 | Added Annexures and Verification Checklist | GMP Compliance | QA Head |