SOP for Identification and Removal of Expired Raw Materials from Storage – V 2.0

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SOP for Identification and Removal of Expired Raw Materials from Storage – V 2.0

Standard Operating Procedure for Identification and Removal of Expired Raw Materials from Storage

Department Warehouse / Quality Assurance
SOP No. SOP/RM/132/2025
Supersedes SOP/RM/132/2022
Page No. Page 1 of 15
Issue Date 27/02/2025
Effective Date 03/03/2025
Review Date 27/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the process for identifying and removing expired raw materials from storage areas to ensure product quality, regulatory compliance, and to prevent the use of non-conforming materials in manufacturing processes.

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals that have a defined shelf life.

3. Responsibilities

  • Warehouse Personnel: Perform regular checks of raw materials, identify expired items, and segregate them from usable stock.
  • Warehouse Manager: Supervise the identification and removal process and ensure timely updates in the inventory system.
  • Quality Assurance (QA): Verify the removal of expired materials and ensure proper documentation and regulatory compliance.

4. Accountability

The Warehouse Manager is accountable for ensuring expired materials are identified and removed in a timely manner. The QA Manager is responsible for verifying compliance with regulatory standards and proper documentation.

5. Procedure

5.1 Identification of Expired Raw Materials

  1. Review of Expiry Dates:
    • Warehouse personnel must review the expiry dates of raw materials during routine inventory checks, following First-Expired-First-Out (FEFO) principles.
    • Identify materials that have reached or are nearing their expiry date.
    • Document identified expired materials in the Expired Material Identification Log (Annexure-1).
  2. Use of ERP Systems:
    • Use the Enterprise Resource Planning (ERP) or inventory management system to generate reports of materials approaching expiry.
    • Cross-check ERP data with physical inventory to ensure accuracy.
    • Record ERP verification results in the ERP Expiry Report Log (Annexure-2).
See also  SOP for Checking Raw Material Shipment against Approved Purchase Order (PO) - V 2.0

5.2 Segregation and Labeling of Expired Materials

  1. Segregation Procedures:
    • Immediately segregate expired materials from active inventory and move them to a designated quarantine area for expired materials.
    • Ensure physical barriers or separate storage racks are used to prevent accidental use of expired materials.
    • Document segregation in the Expired Material Segregation Log (Annexure-3).
  2. Labeling Requirements:
    • Clearly label expired materials with “EXPIRED” tags, including the material name, batch number, and date of expiry.
    • Ensure labels are prominently visible and comply with GMP labeling standards.
    • Record labeling details in the Expired Material Labeling Log (Annexure-4).

5.3 Removal and Disposal of Expired Materials

  1. Approval for Disposal:
    • Submit the list of expired materials to the QA department for approval before disposal.
    • QA must verify the materials and sign off on the disposal request.
    • Document approval in the Disposal Approval Log (Annexure-5).
  2. Disposal Procedures:
    • Dispose of expired materials in accordance with environmental regulations and company policies.
    • For hazardous materials, follow specific disposal procedures outlined in the Material Safety Data Sheet (MSDS).
    • Document disposal activities in the Expired Material Disposal Log (Annexure-6).

5.4 Updating Inventory and Documentation

  1. Inventory System Updates:
    • Update the ERP or inventory management system to reflect the removal of expired materials from stock.
    • Ensure all related documentation is attached in the ERP system for audit purposes.
    • Record inventory updates in the Inventory Update Log (Annexure-7).
  2. Record Retention:
    • Maintain all records related to expired materials for a minimum of five years or as required by regulatory authorities.
    • Ensure records are easily accessible for audits and inspections.
    • Document record retention details in the Record Retention Log (Annexure-8).
See also  SOP for Inspection and Receiving of API, Excipients, and Additives - V 2.0

5.5 Handling Deviations and Corrective Actions

  1. Reporting Deviations:
    • Report any deviations, such as the use of expired materials or failure to remove expired stock, to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-9).
  2. Corrective Actions:
    • Investigate the root cause of deviations and implement corrective measures, such as retraining staff or improving tracking systems.
    • Document corrective actions in the Corrective Action Log (Annexure-10).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • ERP: Enterprise Resource Planning
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Expired Material Identification Log (Annexure-1)
  2. ERP Expiry Report Log (Annexure-2)
  3. Expired Material Segregation Log (Annexure-3)
  4. Expired Material Labeling Log (Annexure-4)
  5. Disposal Approval Log (Annexure-5)
  6. Expired Material Disposal Log (Annexure-6)
  7. Inventory Update Log (Annexure-7)
  8. Record Retention Log (Annexure-8)
  9. Deviation Log (Annexure-9)
  10. Corrective Action Log (Annexure-10)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO GMP Guidelines
  • ISO 9001:2015 – Quality Management Systems Requirements

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Expired Material Identification Log

Date Material Name Batch Number Expiry Date Identified By
27/02/2025 API A Batch1234 25/02/2025 Ravi Kumar
See also  SOP for Handling and Movement of Quarantined Hazardous Raw Materials - V 2.0

Annexure-2: ERP Expiry Report Log

Date Material Name Batch Number ERP Status Verified By
27/02/2025 API A Batch1234 Expired Sunita Sharma

Annexure-3: Expired Material Segregation Log

Date Material Name Batch Number Segregated By Storage Location
27/02/2025 API A Batch1234 Amit Joshi Quarantine Area – Shelf 3

Annexure-4: Expired Material Labeling Log

Date Material Name Batch Number Label Applied By
27/02/2025 API A Batch1234 Neha Verma

Annexure-5: Disposal Approval Log

Date Material Name Batch Number Approved By
28/02/2025 API A Batch1234 QA Manager – Priya Singh

Annexure-6: Expired Material Disposal Log

Date Material Name Batch Number Disposal Method Disposed By
01/03/2025 API A Batch1234 Incineration Rohit Sharma

Annexure-7: Inventory Update Log

Date Material Name Batch Number Updated By
01/03/2025 API A Batch1234 Anjali Mehta

Annexure-8: Record Retention Log

Date Document Type Retained By Retention Period
01/03/2025 Expired Material Logs Kavita Nair 5 Years

Annexure-9: Deviation Log

Date Deviation Description Reported By Corrective Action Taken
01/03/2025 Expired material found in active inventory Sachin Gupta Immediate removal and retraining of staff

Annexure-10: Corrective Action Log

Date Corrective Action Description Implemented By Verified By
02/03/2025 Enhanced training on expired material handling Rajeev Menon QA Head – Priya Singh

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
27/02/2025 2.0 Updated Procedures for Expired Material Removal Regulatory Compliance QA Head
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