Standard Operating Procedure for FIFO and FEFO Implementation in API Warehouse Management
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/010/2025 |
| Supersedes | SOP/API/010/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To describe the procedure for implementing FIFO (First In First Out) and FEFO (First Expiry First Out) material handling principles in the warehouse to ensure proper rotation of raw materials, minimize expiry-related losses, and comply with cGMP requirements.
2. Scope
This SOP applies to all raw materials, intermediates, and packaging materials stored in the warehouse of the API manufacturing facility. It covers material receipt, storage, issuance, and stock rotation.
3. Responsibilities
- Warehouse Assistant: Identify material receipt dates, expiry dates, and ensure correct material movement.
- Warehouse Executive: Monitor FIFO/FEFO transactions, verify shelf arrangement, and update logs.
- QA Officer: Conduct periodic audits to ensure compliance and review stock rotation practices.
4. Accountability
The Warehouse Manager is accountable for effective implementation of FIFO and FEFO procedures and maintaining traceability in the warehouse system.
5. Procedure
5.1 Understanding FIFO and FEFO
- FIFO (First In, First Out): Materials received earliest shall be issued first regardless of expiry date. Applicable to non-expiry-sensitive items.
- FEFO (First Expiry, First Out): Materials with earliest expiry date shall be issued first. This is mandatory for expiry-sensitive materials like APIs, excipients, and volatile solvents.
5.2 Material Segregation and Labeling
- At the time of receipt, label each material with:
- GRN Number
- Receipt Date
- Manufacture and Expiry Date
- Affix color-coded tags for expiry category materials (e.g., orange for < 6 months expiry).
5.3 Material Arrangement on Racks
- Arrange materials such that:
- Earliest receipt (FIFO) or expiry (FEFO) material is positioned in front.
- Clear identification of each container’s status using barcode/label.
- Do not rearrange materials manually unless directed under deviation handling.
5.4 Issuance of Materials
- Before issuance, warehouse staff must verify:
- Expiry date (FEFO)
- GRN or receipt date (FIFO)
- Use the inventory system to flag earliest expiry/receipt lots for automatic selection.
- In case material with earlier expiry is not used, a justification must be recorded.
5.5 Monitoring and Compliance
- QA shall review FIFO/FEFO logs weekly and conduct random shelf audits monthly.
- Warehouse team must update the “FIFO/FEFO Compliance Log” (Annexure-1).
- Any deviation from FIFO/FEFO must be documented in “Rotation Deviation Form” (Annexure-2).
5.6 Handling of Expired or Short-Expiry Stock
- Identify materials within 90 days of expiry and move them to “Use First” zone.
- Expired materials shall be moved to “Rejected Material Area” and logged as per SOP/API/012/2025.
6. Abbreviations
- SOP: Standard Operating Procedure
- GRN: Goods Receipt Note
- FEFO: First Expiry First Out
- FIFO: First In First Out
- QA: Quality Assurance
7. Documents
- FIFO/FEFO Compliance Log (Annexure-1)
- Rotation Deviation Form (Annexure-2)
- Shelf Audit Checklist (Annexure-3)
8. References
- ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
- 21 CFR Part 211.80 – Warehousing procedures
- WHO TRS 986 Annex 2 – GMP for warehouse and distribution
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | Rajesh Kumar | Sunita Reddy | Manoj Verma |
| Designation | Warehouse Executive | QA Officer | QA Manager |
| Department | API Manufacturing | Quality Assurance | Quality Assurance |
11. Annexures
Annexure-1: FIFO/FEFO Compliance Log
| Date | Material | Batch | FEFO/FIFO Used | Verified By | Remarks |
|---|---|---|---|---|---|
| 13/04/2025 | API A | AP202503 | FEFO | Rajesh Kumar | Issued as per expiry |
Annexure-2: Rotation Deviation Form
| Date | Material | Reason for Deviation | Approved By | CAPA (If Any) |
|---|---|---|---|---|
| 13/04/2025 | Excipient X | Damaged older lot | Sunita Reddy | Use next batch with note |
Annexure-3: Shelf Audit Checklist
| Audit Date | Auditor | Area Audited | Observation | Corrective Action |
|---|---|---|---|---|
| 10/04/2025 | Sunita Reddy | Rack B1 | Material with earlier expiry behind | Rearranged |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial version | GMP implementation | QA Head |
| 13/04/2025 | 2.0 | Integrated FEFO tracking & audit | Annual SOP review | QA Head |