Standard Operating Procedure for QA Oversight of IPC Activities in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/120/2025 |
| Supersedes | SOP/API/120/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To define the role of Quality Assurance (QA) in the review, verification, and oversight of IPC (In-Process Control) activities carried out during API manufacturing to ensure all IPC operations are compliant with cGMP and internal quality standards.
2. Scope
This SOP applies to QA personnel responsible for monitoring IPC-related operations including sampling, data entry, IPC result verification,
equipment status verification, and sign-off on batch documents across all stages of API production.
3. Responsibilities
- QA Officer: Perform real-time checks on IPC activities, review records, verify test results, and escalate any deviations or abnormalities.
- QA Executive/Manager: Approve final IPC summaries, sign-off BMRs, and ensure adherence to established IPC specifications.
- Production Chemist: Communicate with QA for each IPC stage and comply with verification requirements.
4. Accountability
The Head – QA is accountable for ensuring that IPC oversight is conducted according to approved procedures and that all observations, reviews, and approvals are properly documented and traceable.
5. Procedure
5.1 QA Review of IPC Sampling
- QA shall verify that:
- IPC samples are drawn as per SOP/API/081/2025
- Correct containers and labeling are used
- Sampling tools are clean and traceable
- Any deviation in sampling procedure shall be documented and reviewed for impact on product quality.
5.2 Verification of IPC Parameters
- QA shall verify that:
- IPC results are within defined limits
- Instrument calibration and status are valid
- Entries in logbooks and BMRs are complete, signed, and dated
- Where IPC data is generated in QC (e.g., LOD, pH), QA shall cross-check raw data and test results with the reported values in BMR.
5.3 IPC Stage Sign-Off
- Before progressing to the next manufacturing stage:
- QA shall verify the current IPC results
- Approve stage-wise clearance in the BMR or IPC checklist
- Ensure compliance with IPC hold times and frequencies
5.4 Observation of IPC Execution
- QA shall conduct random on-the-spot checks to verify:
- Correct usage of SOPs and specifications
- Equipment cleanliness and status tags
- Personnel training and qualification
- QA shall document observations in the IPC Oversight Log (Annexure-1).
5.5 Documentation and Archival
- QA shall ensure:
- All IPC records are legible, error-free, and traceable
- Overwriting is properly justified and signed
- Final IPC summary is approved before batch release
- QA shall archive the IPC Oversight Logs and associated records with the batch documentation for review during audits.
6. Abbreviations
- IPC: In-Process Control
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- LOD: Loss on Drying
7. Documents
- IPC Oversight Logbook (Annexure-1)
- Batch Manufacturing Record (BMR)
- IPC Summary Sheet
8. References
- ICH Q10 – Pharmaceutical Quality System
- 21 CFR Part 211 – US FDA cGMP Guidelines
- WHO TRS 986 – GMP for APIs
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 Oversight Logbook
| Date | Batch No. | Stage Observed | IPC Parameter | Observation | QA Officer | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | Drying | LOD | LOD out of spec, sample preserved | Sunita Reddy | Deviation initiated |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Added IPC stage clearance and checklist references | Audit Observation | QA Head |