Standard Operating Procedure for FIFO/FEFO Implementation in Quarantine Storage

Department	Warehouse / Quality Assurance / Inventory Management
SOP No.	SOP/RM/072/2025
Supersedes	SOP/RM/072/2022
Page No.	Page 1 of 15
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) describes the process for implementing First-In-First-Out (FIFO) and First-Expired-First-Out (FEFO) inventory management principles in the quarantine storage area to ensure proper material usage, minimize waste, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials stored in the quarantine area prior to Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

• Warehouse Personnel: Organize and manage raw materials in accordance with FIFO and FEFO principles.
• Quality Assurance (QA): Monitor compliance with FIFO/FEFO procedures and approve material movements.
• Inventory Control Team: Maintain accurate records of material movement based on FIFO/FEFO guidelines.

4. Accountability

The Warehouse Manager is responsible for implementing FIFO/FEFO procedures in the quarantine area. The QA Manager ensures compliance with regulatory requirements, while the Inventory Control Team manages documentation and tracking.

5. Procedure

5.1 Definitions and Principles

1. FIFO (First-In-First-Out):
   • Materials received first are the first to be used, regardless of their expiry date.
   • Used primarily for non-perishable materials or those with uniform expiry dates.
2. FEFO (First-Expired-First-Out):
   • Materials with the earliest expiry date are used first, regardless of the receipt date.
   • Used for perishable, temperature-sensitive, or time-critical materials.

5.2 FIFO/FEFO Implementation in Quarantine Storage

1. Material Classification:
   • Classify materials into two categories:
     • Category A: Non-perishable materials (apply FIFO)
     • Category B: Perishable or sensitive materials (apply FEFO)
2. Labeling and Identification:
   • Clearly label materials with batch numbers, manufacturing dates, and expiry dates.
   • Use color-coded stickers for quick identification:
     • FIFO materials: Blue stickers
     • FEFO materials: Red stickers
3. Storage Arrangement:
   • Store materials in designated FIFO or FEFO zones in the quarantine area.
   • Ensure materials are organized so that the oldest stock or earliest expiry is positioned at the front for easy access.

5.3 Material Movement and Tracking

1. Movement Procedures:
   • When moving materials for sampling or release, follow the FIFO or FEFO principle as per material classification.
   • Record all material movements in the FIFO/FEFO Movement Log (Annexure-1).
2. Inventory System Updates:
   • Update the digital inventory system after each movement to reflect changes in stock.
   • Ensure the system generates alerts for materials approaching expiry in the FEFO category.

5.4 Handling Deviations

1. Deviation Reporting:
   • Report any deviations from FIFO/FEFO procedures to the QA Manager immediately.
   • Document deviations in the FIFO/FEFO Deviation Report (Annexure-2).
2. Corrective Actions:
   • Investigate the root cause of the deviation and implement corrective measures to prevent recurrence.
   • Document corrective actions in the Corrective Action Log (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• FIFO: First-In-First-Out
• FEFO: First-Expired-First-Out

7. Documents

1. FIFO/FEFO Movement Log (Annexure-1)
2. FIFO/FEFO Deviation Report (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: FIFO/FEFO Movement Log

Date	Material Name	Batch Number	Expiry Date	Movement Type (FIFO/FEFO)	Moved By	Verified By (QA)
01/02/2025	API-X	X-2025-001	01/01/2027	FIFO	Ravi Kumar	Anjali Mehta
01/02/2025	Excipient-Y	Y-2025-002	15/01/2026	FEFO	Sunita Sharma	Ajay Singh

Annexure-2: FIFO/FEFO Deviation Report

Date	Material Name	Batch Number	Deviation Description	Reported By	Corrective Action Taken
02/02/2025	Excipient-Y	Y-2025-002	Incorrect Batch Released (Not Following FEFO)	Ravi Kumar	Batch Recalled and Correct Batch Released

Annexure-3: Corrective Action Log

Date	Issue	Corrective Action	Responsible Person	Follow-Up Required
03/02/2025	Deviation from FEFO Process	Staff Training on FEFO Procedures	Ajay Singh	Yes

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated FIFO/FEFO Implementation Procedures	Regulatory Compliance	QA Head