Skip to content
  • Clinical Studies
  • Pharma GMP
  • Pharma Tips
  • Stability Studies
  • Pharma Books
  • Schedule M

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

SOP for FIFO/FEFO Implementation in Quarantine Storage – V 2.0

Posted on By

SOP for FIFO/FEFO Implementation in Quarantine Storage – V 2.0

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.

See also  SOP for Managing Temperature-Controlled Zones in Warehouses - V 2.0

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.

See also  SOP for Handling and Storage of Temperature-Sensitive Raw Materials - V 2.0

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)
See also  SOP for Sampling of Solvents and Flammable Raw Materials in Quarantine - V 2.0

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
Raw Material Warehouse V 2.0 Tags:Audit compliance in material storage, Contamination prevention in warehouses, Documentation in warehouse operations, Emergency procedures in warehouses, Equipment maintenance in warehouses, FIFO method in inventory, Handling of hazardous materials, Inventory management SOP, Labeling requirements in warehouses, Loading and unloading procedures, Material inspection protocol, Material receiving process, Material segregation guidelines, Pest control in storage areas, Quality control in warehousing, Raw material handling SOP, Return material handling SOP, Safety procedures for material handling, Security measures for stored materials, Spill response procedures, Storage conditions for raw materials, Temperature and humidity control in storage, Training for warehouse personnel, Warehouse storage procedures, Waste management in warehouses

Post navigation

Previous Post: Ointments: SOP for Handling Deviation Reports – V 2.0
Next Post: Tablets: SOP for Particle Size Analysis in Slow-Release Tablets – V 2.0

Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

Read SOPs in your Language:

 - 
Bengali
 - 
bn
English
 - 
en
Gujarati
 - 
gu
Hindi
 - 
hi
Malayalam
 - 
ml
Marathi
 - 
mr
Punjabi
 - 
pa
Tamil
 - 
ta
Telugu
 - 
te

NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

Copyright © 2025 SOP Guide for Pharma.

Powered by PressBook WordPress theme

Go to mobile version