Standard Operating Procedure for IPC Sample Retention Procedure in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/098/2025 |
| Supersedes | SOP/API/098/2022 |
| 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 the collection, labeling, handling, storage, and retention of In-Process Control (IPC) samples taken during API manufacturing to ensure traceability and availability for re-testing or investigation, if required.
2. Scope
This SOP applies to all IPC samples collected during different manufacturing stages of Active Pharmaceutical Ingredients (APIs), including reaction, isolation, drying, milling, and blending.
3. Responsibilities
- Production Chemist: Collect IPC samples as per the sampling plan and transfer them with appropriate labeling.
- QC Analyst: Verify labeling, store samples under defined conditions, and maintain sample retention records.
- QA Officer: Review retention compliance and initiate disposal approval post-retention period.
4. Accountability
Production and QC Heads are accountable for sample integrity, and the QA Head is accountable for procedural compliance and record maintenance.
5. Procedure
5.1 Collection of IPC Samples
- IPC samples shall be collected from designated sampling points as mentioned in the MFR/BMR.
- Use cleaned and labeled containers suitable for the sample type (e.g., glass or polypropylene).
- Each sample must be representative and collected using sanitized tools.
5.2 Labeling of IPC Samples
- Label each IPC sample with:
- Product Name
- Batch Number
- Stage (e.g., post-reaction, drying)
- Date and Time of Sampling
- Sampled By
5.3 Sample Transfer and Logging
- Transfer samples to QC in a closed tray or container.
- Enter sample details in the IPC Sample Retention Logbook (Annexure-1).
5.4 Retention Conditions
- Store IPC samples in a designated cabinet or chamber in the QC area, labeled as “IPC Retention Area.”
- Maintain storage conditions as per product requirements (e.g., 25°C ± 2°C / 60% RH ± 5%).
- Ensure proper segregation from raw material and finished product samples.
5.5 Retention Period
- Retain IPC samples until batch release and a minimum of 30 days thereafter.
- In case of batch failure or investigation, retain until disposition or closure.
- Post-retention, discard samples as per SOP for Sample Disposal with QA approval.
5.6 Handling Deviations
- Any missing, mislabelled, or degraded samples must be reported to QA immediately.
- Document deviation using the Deviation Report form and investigate root cause.
6. Abbreviations
- SOP: Standard Operating Procedure
- IPC: In-Process Control
- QC: Quality Control
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- MFR: Master Formula Record
7. Documents
- IPC Sample Retention Logbook (Annexure-1)
- Deviation Report (if applicable)
- Batch Manufacturing Record
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 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 Sample Retention Logbook
| Date | Batch No. | Stage | Sample Qty | Location | Sampled By | Remarks |
|---|---|---|---|---|---|---|
| 13/04/2025 | API-20250413 | Drying | 5 g | Shelf 2 – IPC Cabinet | Complies |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | Regulatory Requirement | QA Head |
| 13/04/2025 | 2.0 | Clarified retention period and deviation procedure | Audit Compliance | QA Head |