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

1. FIFO (First In, First Out): Materials received earliest shall be issued first regardless of expiry date. Applicable to non-expiry-sensitive items.
2. 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

1. At the time of receipt, label each material with:
   • GRN Number
   • Receipt Date
   • Manufacture and Expiry Date
2. Affix color-coded tags for expiry category materials (e.g., orange for < 6 months expiry).

5.3 Material Arrangement on Racks

1. 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.
2. Do not rearrange materials manually unless directed under deviation handling.

5.4 Issuance of Materials

1. Before issuance, warehouse staff must verify:
   • Expiry date (FEFO)
   • GRN or receipt date (FIFO)
2. Use the inventory system to flag earliest expiry/receipt lots for automatic selection.
3. In case material with earlier expiry is not used, a justification must be recorded.

5.5 Monitoring and Compliance

1. QA shall review FIFO/FEFO logs weekly and conduct random shelf audits monthly.
2. Warehouse team must update the “FIFO/FEFO Compliance Log” (Annexure-1).
3. Any deviation from FIFO/FEFO must be documented in “Rotation Deviation Form” (Annexure-2).

5.6 Handling of Expired or Short-Expiry Stock

1. Identify materials within 90 days of expiry and move them to “Use First” zone.
2. 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

1. FIFO/FEFO Compliance Log (Annexure-1)
2. Rotation Deviation Form (Annexure-2)
3. 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