SOP for Tracking Shelf-Life of Quarantined Materials – V 2.0

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SOP for Tracking Shelf-Life of Quarantined Materials – V 2.0

Standard Operating Procedure for Tracking Shelf-Life of Quarantined Materials

Department Warehouse / Quality Assurance / Inventory Management
SOP No. SOP/RM/071/2025
Supersedes SOP/RM/071/2022
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) outlines the process for tracking and managing the shelf-life of raw materials stored in quarantine to prevent the use of expired materials and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

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

3. Responsibilities

  • Warehouse Personnel: Monitor expiration dates of quarantined materials, update records, and flag materials nearing expiry.
  • Quality Assurance (QA): Review shelf-life tracking records and authorize actions for expired or near-expiry materials.
  • Inventory Control Team: Maintain up-to-date digital records of all quarantined materials and their shelf-life status.

4. Accountability

The Warehouse Manager is responsible for ensuring that shelf-life tracking is performed accurately. The QA Manager ensures compliance with regulatory requirements, while the Inventory Control Team manages the tracking system and documentation.

5. Procedure

5.1 Recording Shelf-Life Information

  1. Initial Documentation:

    • Upon receipt of raw materials, record the following information in the Quarantine Shelf-Life Log (Annexure-1):
      • Material Name
      • Batch/Lot Number
      • Manufacturing Date
      • Expiry Date
      • Quarantine Entry Date
    • Assign a unique Shelf-Life ID for tracking purposes.
  2. Labeling:

    • Ensure all materials are clearly labeled with their manufacturing and expiry dates.
    • Use color-coded stickers to differentiate between:
      • Materials within 6 months of expiry (Yellow)
      • Materials within 3 months of expiry (Red)
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5.2 Shelf-Life Monitoring and Alerts

  1. Routine Monitoring:

    • Warehouse personnel must review shelf-life data weekly and update the status of all materials nearing expiry.
    • Flag materials approaching expiry in the Shelf-Life Alert Log (Annexure-2).
  2. Automated Alerts:

    • Utilize digital inventory management systems to set automated alerts for materials nearing expiry.
    • Ensure alerts are set at two intervals:
      • 6 months before expiry
      • 3 months before expiry

5.3 Handling Materials Nearing Expiry

  1. Review and Approval:

    • QA personnel must review flagged materials and decide whether to expedite QC testing or plan for disposal.
    • Document decisions in the Near-Expiry Material Review Log (Annexure-3).
  2. Expedited Testing:

    • If materials are still within their shelf-life, expedite their QC testing to ensure they can be used before expiry.
  3. Quarantine and Disposal:

    • Materials that have expired must be immediately quarantined in a separate area and labeled ‘Expired’.
    • Arrange for the safe disposal of expired materials and record the activity in the Expired Material Disposal Log (Annexure-4).

5.4 Shelf-Life Extension Procedures

  1. Eligibility Criteria:

    • For certain raw materials, shelf-life extension may be possible following retesting and stability analysis.
    • QA will determine eligibility based on material type, storage conditions, and regulatory guidelines.
  2. Retesting Protocol:

    • Send materials eligible for extension to the QC lab for retesting.
    • Document retesting results and extension approval in the Shelf-Life Extension Log (Annexure-5).
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5.5 Deviation and Corrective Actions

  1. Deviation Reporting:

    • Any deviation from the shelf-life tracking procedure, such as failure to flag near-expiry materials, must be reported to QA.
    • Document deviations in the Shelf-Life Deviation Report (Annexure-6).
  2. Corrective Actions:

    • Investigate root causes of deviations and implement corrective actions to prevent recurrence.
    • Document corrective actions in the Corrective Action Log (Annexure-7).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • GRN: Goods Receipt Note

7. Documents

  1. Quarantine Shelf-Life Log (Annexure-1)
  2. Shelf-Life Alert Log (Annexure-2)
  3. Near-Expiry Material Review Log (Annexure-3)
  4. Expired Material Disposal Log (Annexure-4)
  5. Shelf-Life Extension Log (Annexure-5)
  6. Shelf-Life Deviation Report (Annexure-6)
  7. Corrective Action Log (Annexure-7)

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: Quarantine Shelf-Life Log

Date of Entry Material Name Batch Number Manufacturing Date Expiry Date Shelf-Life ID Status
01/02/2025 API-X X-2025-001 01/01/2025 01/01/2027 SL-001 Under Test
01/02/2025 Excipient-Y Y-2025-002 15/01/2025 15/01/2026 SL-002 Under Test
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Annexure-2: Shelf-Life Alert Log

Date Shelf-Life ID Material Name Expiry Date Alert Type Flagged By
01/07/2025 SL-002 Excipient-Y 15/01/2026 6 Months to Expiry Ravi Kumar

Annexure-3: Near-Expiry Material Review Log

Date Material Name Batch Number Expiry Date Reviewed By (QA) Decision
01/10/2025 Excipient-Y Y-2025-002 15/01/2026 Anjali Mehta Expedite Testing

Annexure-4: Expired Material Disposal Log

Date Material Name Batch Number Expiry Date Disposed By Verified By (QA)
16/01/2026 Excipient-Y Y-2025-002 15/01/2026 Ajay Singh Anjali Mehta

Annexure-5: Shelf-Life Extension Log

Date Material Name Batch Number Original Expiry Date New Expiry Date Approved By (QA)
01/12/2025 API-X X-2025-001 01/01/2027 01/01/2028 Sunita Sharma

Annexure-6: Shelf-Life Deviation Report

Date Deviation Description Reported By Corrective Action Taken Verified By (QA)
02/02/2025 Missed Near-Expiry Flag Ravi Kumar Reviewed and Flagged Correctly Ajay Singh

Annexure-7: Corrective Action Log

Date Issue Corrective Action Responsible Person Follow-Up Required
02/02/2025 Incorrect Shelf-Life Entry Corrected Digital Records and Trained Staff Sunita Sharma 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 Shelf-Life Tracking Procedures and Documentation Formats Regulatory Compliance QA Head
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