Standard Operating Procedure for Handling Expired Raw Materials in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/012/2025 |
| Supersedes | SOP/API/012/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To describe the systematic procedure for identification, segregation, recording, evaluation, and disposal of expired raw materials in order to prevent their unintentional use in production and ensure GMP compliance in API manufacturing.
2. Scope
This SOP applies to all raw materials (APIs, excipients, solvents, reagents) stored in the warehouse that have exceeded their manufacturer-defined expiry or retest date.
3. Responsibilities
- Warehouse Staff: Monitor expiry dates, segregate expired materials, label and record details.
- QA Officer: Review expired material records, authorize disposal or re-evaluation.
- EHS Officer: Ensure proper disposal in accordance with environmental regulations.
4. Accountability
The QA Manager and Warehouse Manager are jointly accountable for the compliant and safe handling of expired raw materials.
5. Procedure
5.1 Identification of Expired Materials
- Warehouse staff shall conduct a monthly review of all stored raw materials using the “Material Expiry Monitoring Register” (Annexure-1).
- Materials nearing expiry within 30 days should be flagged and reviewed for possible accelerated use or disposal.
- Materials that have crossed expiry/retest date shall be labeled “EXPIRED – DO NOT USE.”
5.2 Segregation of Expired Materials
- Immediately transfer expired materials to a designated “Expired Material Quarantine Area.”
- Ensure the area is physically separated and marked with “RESTRICTED ACCESS – EXPIRED MATERIALS.”
- Update storage location in the inventory control system.
5.3 Documentation
- Log each expired item in the “Expired Material Log” (Annexure-2) with:
- Material Name
- Batch No.
- Manufacturer
- Expiry Date
- Date Identified
- Quantity
- Prepare the “Expired Material Evaluation Form” (Annexure-3) for QA review.
5.4 Evaluation and Final Disposition
- QA evaluates whether the expired material can be:
- Sent for re-analysis (if retest date is defined)
- Destroyed (if no retest date or failed re-evaluation)
- If destroyed, coordinate with the EHS department for safe disposal via approved vendors.
- Complete “Material Disposal Record” and retain for audit purposes.
5.5 Preventive Measures
- Implement FEFO-based storage to avoid expiry-related wastage.
- Train warehouse personnel in shelf-life management practices.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- EHS: Environment, Health & Safety
- FEFO: First Expiry, First Out
7. Documents
- Material Expiry Monitoring Register (Annexure-1)
- Expired Material Log (Annexure-2)
- Expired Material Evaluation Form (Annexure-3)
8. References
- ICH Q7 – GMP Guidelines for Active Pharmaceutical Ingredients
- 21 CFR Part 211.192 – Production record review
- WHO TRS 986 Annex 2 – GMP for warehouse operations
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Designation | Warehouse Executive | QA Officer | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: Material Expiry Monitoring Register
| Date | Material | Batch No. | Expiry Date | Status | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | Citric Acid | CA202402 | 31/03/2025 | Expired | Moved to Expired Area |
Annexure-2: Expired Material Log
| Date | Material | Batch | Qty | Identified By | Action |
|---|---|---|---|---|---|
| 13/04/2025 | Citric Acid | CA202402 | 25 kg | Warehouse Staff | Sent for disposal |
Annexure-3: Expired Material Evaluation Form
| Material | Batch | Expiry Date | Retest Option | QA Recommendation | Disposition |
|---|---|---|---|---|---|
| Citric Acid | CA202402 | 31/03/2025 | Not Applicable | Dispose | Incineration |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Version | Regulatory Compliance | QA Head |
| 13/04/2025 | 2.0 | Included Evaluation Form and Quarantine Area Segregation | GMP Update | QA Head |