API Manufacturing: SOP for Batch Record Documentation and Verification – V 2.0

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API Manufacturing: SOP for Batch Record Documentation and Verification – V 2.0

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.

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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

  1. Only black or blue indelible ink shall be used for manual entries.
  2. Entries shall be made at the time the activity is performed (real-time recording).
  3. Each entry must include date, time (where required), signature, and designation of the person performing the task.
  4. Overwriting is prohibited. In case of errors, strike through the incorrect entry with a single line, record the correction, and initial with date.
  5. Do not leave blank fields. If a section is not applicable, write “NA” with justification if needed.

5.2 Data Entry Process

  1. Record all input materials with batch numbers, quantity used, and weighment time in the BMR.
  2. Document process parameters such as temperature, pH, agitation speed, pressure, and hold time as per defined intervals or batch stages.
  3. In-process testing data (e.g., clarity, reaction completion) should be entered by the chemist or IPC officer at the time of sampling.
  4. Ensure each process step is signed off by the operator and checked by the supervisor.
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5.3 Review and Verification

  1. QA shall review BMR entries for:
    • Completeness of information
    • Correct sequence of events
    • Deviations or corrections made
    • Authorization and verification signatures
  2. Identify and highlight any missing data or discrepancies using the “BMR Verification Checklist” (Annexure-1).
  3. Request corrections through deviation/CAPA route where required.

5.4 Batch Record Reconciliation and Archiving

  1. Ensure reconciliation of all raw materials, intermediates, and yields at each step.
  2. QA signs final approval section of the BMR post-review.
  3. 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

  1. BMR Verification Checklist (Annexure-1)
  2. Deviation/CAPA Form (Annexure-2)
  3. BMR Issue and Retrieval Log (Annexure-3)
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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
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