Standard Operating Procedure for Documentation Review of IPC Checks in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/110/2025
Supersedes	SOP/API/110/2022
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 standardized procedure for reviewing and verifying the documentation of In-Process Control (IPC) checks recorded during API manufacturing, ensuring data accuracy, compliance with cGMP, and traceability for quality assurance and audits.

2. Scope

This SOP applies to all IPC documentation including but not limited to logbooks, Batch Manufacturing Records (BMRs), and supplementary analytical reports generated during each stage of API manufacturing.

3. Responsibilities

• QA Officer: Review and cross-check IPC records for completeness and accuracy, ensure that deviations are documented and resolved.
• Production Supervisor: Ensure proper documentation during batch execution and support QA in answering any queries related to IPC data.
• QC Analyst: Provide supporting analytical data and confirmation of IPC test results as required during the review process.

4. Accountability

The QA Head is accountable for the overall documentation review process, while the Production Head is responsible for ensuring that accurate IPC data is captured during operations.

5. Procedure

5.1 Review Process Initiation

1. At the end of each shift or process batch, the designated QA Officer collects all IPC documentation including logbooks, BMR sections, and electronic records.
2. The QA Officer confirms the presence of required data fields such as:
   • Date and time of entry
   • Batch number
   • Process stage and parameter measured
   • Observed results against acceptance criteria
   • Signatures/initials of responsible personnel
3. Any missing or illegible entries must be immediately reported to the Production Supervisor for immediate rectification.

5.2 Cross-Verification and Accuracy Check

1. Compare the recorded IPC data with corresponding analytical reports (e.g., pH meter readings, LOD test results, or yield calculations) for consistency.
2. If discrepancies or deviations are identified:
   • Document the discrepancy in the IPC Verification Observation Form (Annexure-1).
   • Notify the Production Supervisor and QC Analyst for further clarification and corrective action.
3. Verify that all corrections in the logbooks have been made following good documentation practices:
   • Striking through errors, with initials and date of correction

5.3 Documentation and Reporting

1. The QA Officer compiles a summary report at the end of the batch review period (e.g., daily or per batch) including:
   • Summary of IPC data reviewed
   • Any deviations or outliers identified
   • Actions taken to resolve discrepancies
2. Attach copies of all reviewed records and any deviation forms to the Batch Manufacturing Record (BMR).
3. Maintain electronic or hard copy archives as per the Document Control SOP for a minimum retention period of 5 years.

5.4 Deviations and CAPA

1. If significant discrepancies are found that may impact product quality or compliance:
   • Initiate a formal deviation or CAPA (Corrective and Preventive Action) request.
   • Ensure that a root cause analysis is performed and documented.
   • Implement corrective measures and verify through a re-review of IPC records.
2. Document the resolution and update the IPC Verification Observation Form with final QA sign-off.

5.5 Periodic Quality Audits

1. QA shall perform periodic audits of IPC records to ensure consistent adherence to the SOP and GMP requirements.
2. Audit findings should be documented and communicated to relevant departments with recommendations for improvement.

6. Abbreviations

• IPC: In-Process Control
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• CAPA: Corrective and Preventive Action

7. Documents

1. IPC Verification Observation Form (Annexure-1)
2. Batch Manufacturing Record (BMR)
3. Electronic / Hard Copy Archives of IPC Data

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – US FDA cGMP Guidelines
• WHO TRS 986 – GMP 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: IPC Verification Observation Form

Date	Batch No.	Parameter Reviewed	Observation	Action Taken	Verified By
13/04/2025	API-20250413	LOD	No discrepancies	N/A