Standard Operating Procedure for IPC Sign-Off on Batch Manufacturing Record in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/117/2025
Supersedes	SOP/API/117/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for proper sign-off of In-Process Control (IPC) checks on the Batch Manufacturing Record (BMR) during API manufacturing. This ensures that all IPC parameters are verified, reviewed, and documented in compliance with cGMP.

2. Scope

This SOP applies to all batches of Active Pharmaceutical Ingredients (API) manufactured at the facility and includes IPC documentation across all processing stages such as charging, reaction, filtration, drying, milling, and blending.

3. Responsibilities

• Production Chemist: Record IPC data in the BMR in real-time and submit for QA review after each stage.
• QC Analyst: Review test results for accuracy and provide required input into the BMR.
• QA Officer: Verify IPC entries, sign-off the results, and ensure all critical checks are documented before stage clearance.

4. Accountability

The QA Head is accountable for ensuring the BMR is reviewed and signed for completeness and accuracy. The Production Head is responsible for maintaining BMR integrity throughout the manufacturing process.

5. Procedure

5.1 IPC Documentation in BMR

1. All IPC parameters performed at each critical stage (e.g., pH, LOD, appearance, yield) must be recorded in the designated BMR section by the production chemist.
2. Data must be:
   • Entered in real-time
   • Written in blue or black ink (non-erasable)
   • Initialed with date and time of record

5.2 QA Sign-Off Procedure

1. Upon completion of IPC testing at a stage:
   • Production shall submit the filled IPC section of BMR to QA.
   • QA Officer shall verify:
     • Completeness of entries
     • Legibility
     • Compliance with acceptance criteria
   • If compliant, QA will:
     • Write “Reviewed” or “Verified” in the remarks column
     • Sign, date, and mention designation in the corresponding row

5.3 Handling Missing or Incorrect Data

1. If any IPC result is missing or incorrectly documented:
   • QA shall hold the BMR and raise an on-the-spot discrepancy
   • Production shall investigate and record the reason using the IPC Data Correction Form (Annexure-1)
   • Correction must follow ALCOA+ principles

5.4 BMR Completion and Handover

1. Upon completion of the entire manufacturing process:
   • QA shall cross-check that all IPC sections have been signed-off and verified.
   • QA shall ensure no open fields, no missing initial/date, and all deviations are referenced and closed.
   • BMR shall then be handed over for QA archival.

6. Abbreviations

• BMR: Batch Manufacturing Record
• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

7. Documents

1. Batch Manufacturing Record (BMR)
2. IPC Data Correction Form (Annexure-1)
3. QA Review Checklist (Annexure-2)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• WHO TRS 986 – GMP Guidelines
• 21 CFR Part 211 – US FDA cGMP Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IPC Data Correction Form

Date	Batch No.	Stage	Error Description	Correction Made	Justification	QA Verified
13/04/2025	API-20250413	Drying	Missing pH	Entered 6.8	Instrument reading recorded on log sheet, but not transcribed	Yes

Annexure-2: QA Review Checklist

Batch No.	IPC Stage	Reviewed (Yes/No)	Initials	Date	Remarks
API-20250413	Filtration	Yes	QA01	13/04/2025	Complete

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
13/04/2025	2.0	Incorporated checklist and ALCOA+ compliance requirements	Audit Update	QA Head