Standard Operating Procedure for Cross-Verification of IPC Data by QA in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/093/2025 |
| Supersedes | SOP/API/093/2022 |
| 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 a systematic procedure for Quality Assurance (QA) to cross-verify In-Process Control (IPC) data documented during the manufacturing of Active Pharmaceutical Ingredients (APIs), ensuring integrity, traceability, and adherence to GMP.
2. Scope
This SOP is applicable to all IPC test data generated and recorded during batch manufacturing of APIs at various stages—reaction, drying, milling, blending,
and packing.
3. Responsibilities
- QA Officer: Verify IPC results in real-time or post-process and ensure records are accurate and compliant.
- Production Chemist: Ensure timely entry of IPC data in Batch Manufacturing Record (BMR).
- QC Analyst: Provide analytical test results and support QA during data review.
4. Accountability
The QA Head is accountable for execution and oversight of IPC data verification and regulatory compliance.
5. Procedure
5.1 IPC Data Recording by Production
- Production personnel shall record IPC observations (pH, LOD, temperature, yield, color, etc.) in the BMR at the time of activity using indelible ink.
- Each entry shall be dated and signed by the responsible person.
- Corrections shall follow GDP practices—strike through, write correct entry, sign, date, and justify.
5.2 QA Verification Method
- QA Officer shall:
- Review IPC entries for completeness and legibility
- Verify results against applicable specifications from MFR or IPC protocols
- Ensure sampling and test frequency align with defined criteria
- Check calculations and transcriptions for accuracy
- For analytical data (e.g., HPLC, TLC), QA shall ensure:
- Chromatograms are attached and traceable
- Results match analytical worksheets and reports
5.3 Handling Discrepancies
- In case of missing, incorrect, or questionable entries, QA shall:
- Notify the Production Head immediately
- Document findings in IPC Verification Observation Form (Annexure-1)
- Initiate deviation as per SOP if discrepancy impacts product quality
- Corrective and Preventive Actions (CAPA) shall be proposed and monitored by QA.
5.4 Verification Frequency
- QA shall verify IPC data:
- During batch manufacturing (at least once per shift)
- During BMR review for batch release
5.5 Documentation and Records
- All QA reviews must be documented and signed with date and time.
- IPC Verification Observation Forms shall be retained with the corresponding BMR.
6. Abbreviations
- IPC: In-Process Control
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- MFR: Master Formula Record
- CAPA: Corrective and Preventive Action
7. Documents
- IPC Verification Observation Form (Annexure-1)
- Batch Manufacturing Record
- Deviation Form (if applicable)
8. References
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 211 – US FDA GMP
- 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 Verified | Observation | Action Taken | Verified By |
|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | LOD | Missing initial | Corrected with justification |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial SOP Release | Quality System Requirement | QA Head |
| 13/04/2025 | 2.0 | Included real-time verification and CAPA linkage | Audit Enhancement | QA Head |