SOP for FIFO and FEFO Implementation in Raw Material Storage – V 2.0

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SOP for FIFO and FEFO Implementation in Raw Material Storage – V 2.0

Standard Operating Procedure for FIFO and FEFO Implementation in Raw Material Storage

Department Warehouse / Quality Assurance
SOP No. SOP/RM/102/2025
Supersedes SOP/RM/102/2022
Page No. Page 1 of 15
Issue Date 02/02/2025
Effective Date 06/02/2025
Review Date 02/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the methodology for implementing First-In-First-Out (FIFO) and First-Expiry-First-Out (FEFO) systems in raw material storage. It ensures proper rotation of stock to maintain material quality and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals. It covers procedures for stock rotation, inventory management, and documentation to support FIFO and FEFO principles.

3. Responsibilities

  • Warehouse Personnel: Implement FIFO and FEFO systems in daily operations, maintain inventory records, and ensure proper material rotation.
  • Quality Assurance (QA): Oversee compliance with FIFO and FEFO principles, conduct periodic audits, and ensure proper documentation.
  • Warehouse Manager: Ensure staff training on FIFO and FEFO procedures, monitor stock movement, and address any discrepancies.

4. Accountability

The Warehouse Manager is accountable for the effective implementation of FIFO and FEFO systems. The QA Manager is responsible for ensuring compliance with GMP requirements through audits and documentation reviews.

5. Procedure

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5.1 Definitions and Key Concepts

  1. First-In-First-Out (FIFO):
    • FIFO ensures that materials received first are used first, regardless of their expiry date.
    • FIFO is typically applied to materials without specific expiry dates or those with long shelf lives.
  2. First-Expiry-First-Out (FEFO):
    • FEFO ensures that materials with the earliest expiry dates are used first, regardless of when they were received.
    • FEFO is applied to materials with defined shelf lives, such as APIs, excipients, and temperature-sensitive materials.

5.2 Implementing FIFO and FEFO Systems

  1. Material Labeling and Identification:
    • All materials must be clearly labeled with:
      • Material Name
      • Batch Number
      • Manufacturing Date
      • Expiry Date (if applicable)
      • Status (Approved, Quarantine, Rejected)
    • Document labeling activities in the Labeling Log (Annexure-1).
  2. Storage Organization:
    • Arrange materials on shelves according to their receipt date (FIFO) or expiry date (FEFO).
    • Use color-coded labels or tags to easily identify the sequence of material use.
    • Maintain a Material Storage Log to record placement details (Annexure-2).

5.3 Material Issuance Procedures

  1. Issuing Materials Based on FIFO:
    • For materials managed under FIFO, select the oldest stock (earliest received) for issuance first.
    • Verify the material details in the Material Issuance Log before issuing (Annexure-3).
  2. Issuing Materials Based on FEFO:
    • For materials managed under FEFO, select the stock with the nearest expiry date for issuance first.
    • Cross-check expiry dates during issuance and record in the FEFO Issuance Log (Annexure-4).

See also  SOP for Receiving and Handling Temperature-Sensitive Pharmaceutical Raw Materials - V 2.0

5.4 Inventory Control and Documentation

  1. Inventory Monitoring:
    • Regularly update inventory records to reflect stock movement and ensure compliance with FIFO and FEFO principles.
    • Record stock updates in the Inventory Control Log (Annexure-5).
  2. Periodic Reconciliation:
    • Conduct periodic inventory reconciliations to ensure accuracy and compliance with FIFO/FEFO systems.
    • Document reconciliation results in the Inventory Reconciliation Log (Annexure-6).

5.5 Training and Compliance Monitoring

  1. Personnel Training:
    • Train warehouse staff on FIFO and FEFO principles, emphasizing the importance of compliance for product quality.
    • Document training sessions in the Training Log (Annexure-7).
  2. QA Compliance Audits:
    • QA will conduct periodic audits to ensure proper implementation of FIFO and FEFO systems.
    • Record audit findings in the Compliance Audit Log (Annexure-8).

6. Abbreviations

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

7. Documents

  1. Labeling Log (Annexure-1)
  2. Material Storage Log (Annexure-2)
  3. Material Issuance Log (Annexure-3)
  4. FEFO Issuance Log (Annexure-4)
  5. Inventory Control Log (Annexure-5)
  6. Inventory Reconciliation Log (Annexure-6)
  7. Training Log (Annexure-7)
  8. Compliance Audit Log (Annexure-8)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • WHO GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

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Annexure-1: Labeling Log

Date Material Name Batch Number Label Status Labeled By
02/02/2025 API-X API-X-2025-001 Quarantine Ravi Kumar

Annexure-2: Material Storage Log

Date Material Name Batch Number Storage Location Stored By
02/02/2025 API-X API-X-2025-001 Shelf A1 Sunita Sharma

Annexure-3: Material Issuance Log

Date Material Name Batch Number Quantity Issued Issued To Issued By
03/02/2025 API-X API-X-2025-001 50 kg Production Anjali Mehta

Annexure-4: FEFO Issuance Log

Date Material Name Batch Number Expiry Date Issued By
03/02/2025 Excipent-Y EX-Y-2024-002 05/2025 Ravi Kumar

Annexure-5: Inventory Control Log

Date Material Name Batch Number Quantity Updated By
04/02/2025 API-X API-X-2025-001 50 kg Sunita Sharma

Annexure-6: Inventory Reconciliation Log

Date Material Name Batch Number Physical Quantity System Quantity Reviewed By
05/02/2025 API-X API-X-2025-001 50 kg 50 kg Anjali Mehta

Annexure-7: Training Log

Date Training Topic Trainer Attendee Name Signature
06/02/2025 FIFO and FEFO Implementation QA Manager Ravi Kumar

Annexure-8: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
07/02/2025 FIFO/FEFO Compliance Audit All procedures compliant N/A Anjali Mehta

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
02/02/2025 2.0 Updated FIFO/FEFO Procedures and Documentation Formats Regulatory Compliance QA Head
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,