SOP Guide for Pharma

SOP for Handling Expired Raw Materials in Quarantine – V 2.0

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SOP for Handling Expired Raw Materials in Quarantine – V 2.0

Standard Operating Procedure for Handling Expired Raw Materials in Quarantine

Department Warehouse / Quality Assurance / Inventory Management
SOP No. SOP/RM/073/2025
Supersedes SOP/RM/073/2022
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 procedure for identifying, handling, and disposing of expired raw materials in the quarantine area to prevent their use in production 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 temperature-sensitive materials stored in the quarantine area prior to Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

4. Accountability

The Warehouse Manager is responsible for identifying and segregating expired materials. The QA Manager ensures proper documentation and compliance with regulatory requirements, while the Inventory Control Team maintains records of expired material handling.

5. Procedure

5.1 Identification of Expired Raw Materials

  1. Routine Monitoring:
    • Warehouse personnel must review shelf-life data weekly to identify materials nearing or past their expiry dates.
    • Record findings in the Expired Material Identification Log (Annexure-1).
  2. Labeling:
    • Clearly label expired materials with ‘EXPIRED’ tags to prevent accidental use.
    • Move expired materials to the designated expired material holding area within the quarantine zone.

5.2 Segregation and Quarantine of Expired Materials

  1. Designated Area:
    • Store expired materials in a separate, clearly marked area to avoid mix-ups with active stock.
    • Ensure the area is secure and access is restricted to authorized personnel only.
  2. Inventory Update:
    • Update the inventory system to reflect the status of expired materials.
    • Record changes in the Expired Material Inventory Log (Annexure-2).

5.3 Review and Authorization for Disposal

  1. QA Review:
    • QA personnel must review the records of expired materials and authorize their disposal.
    • Document authorization in the Expired Material Disposal Authorization Form (Annexure-3).
  2. Disposal Plan:
    • Develop a disposal plan following environmental and regulatory guidelines.
    • Coordinate with the waste management team to ensure safe disposal.

5.4 Disposal of Expired Raw Materials

  1. Disposal Procedure:
    • Transport expired materials to the disposal area using secure, labeled containers.
    • Dispose of materials in accordance with local environmental and safety regulations.
    • Record disposal activities in the Expired Material Disposal Log (Annexure-4).
  2. Documentation and Record-Keeping:
    • Ensure all disposal records are complete, signed, and archived for audit purposes.
    • Maintain records for at least five years or as per regulatory requirements.
See also  SOP for Sampling Frequency and Criteria for Raw Materials in Quarantine - V 2.0

5.5 Handling Deviations

  1. Deviation Reporting:
    • Report any deviations from the expired material handling procedure to the QA Manager.
    • Document deviations in the Expired Material Deviation Report (Annexure-5).
  2. Corrective Actions:
    • Investigate root causes of deviations and implement corrective measures.
    • Document corrective actions in the Corrective Action Log (Annexure-6).

6. Abbreviations

7. Documents

  1. Expired Material Identification Log (Annexure-1)
  2. Expired Material Inventory Log (Annexure-2)
  3. Expired Material Disposal Authorization Form (Annexure-3)
  4. Expired Material Disposal Log (Annexure-4)
  5. Expired Material Deviation Report (Annexure-5)
  6. Corrective Action Log (Annexure-6)

8. References

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 of Identification Material Name Batch Number Expiry Date Identified By
01/02/2025 API-X X-2023-001 31/01/2025 Ravi Kumar

Annexure-2: Expired Material Inventory Log

Date Material Name Batch Number Expiry Date Moved to Expired Area By Verified By (QA)
01/02/2025 API-X X-2023-001 31/01/2025 Sunita Sharma Anjali Mehta

Annexure-3: Expired Material Disposal Authorization Form

Date Material Name Batch Number Expiry Date Authorized By (QA)
02/02/2025 API-X X-2023-001 31/01/2025 Anjali Mehta

Annexure-4: Expired Material Disposal Log

Date Material Name Batch Number Disposal Method Disposed By Verified By (QA)
03/02/2025 API-X X-2023-001 Incineration Ajay Singh Sunita Sharma

Annexure-5: Expired Material Deviation Report

Date Deviation Description Reported By Corrective Action Taken Verified By (QA)
04/02/2025 Expired Material Not Segregated on Time Ravi Kumar Segregation Completed and Staff Retrained Anjali Mehta

Annexure-6: Corrective Action Log

Date Issue Corrective Action Responsible Person Follow-Up Required
05/02/2025 Missed Expiry Date Implemented Weekly Expiry Checks Sunita Sharma Yes
See also  SOP for Inspection of Incoming Raw Materials Packaging - V 2.0

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 Expired Material Handling Procedures Regulatory Compliance QA Head

SOP for Documentation of Quarantined Material Status – V 2.0

Standard Operating Procedure for Documentation of Quarantined Material Status

Department Warehouse / Quality Assurance / Inventory Management
SOP No. SOP/RM/074/2025
Supersedes SOP/RM/074/2022
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 documenting the status of raw materials in the quarantine area to ensure accurate tracking, compliance with Good Manufacturing Practices (GMP), and proper material management.

2. Scope

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

3. Responsibilities

4. Accountability

The Warehouse Manager is responsible for ensuring the proper documentation of quarantined materials. The QA Manager ensures compliance with GMP standards, while the Inventory Control Team is responsible for maintaining accurate records.

5. Procedure

5.1 Initial Documentation at Receipt

  1. Material Receipt Logging:
    • Upon receipt, document the following information in the Quarantine Material Log (Annexure-1):
      • Material Name
      • Batch/Lot Number
      • Supplier Name
      • Goods Receipt Note (GRN) Number
      • Date of Receipt
      • Initial Status: “Under Test”
  2. Labeling:
    • Ensure each received material is labeled with a quarantine tag indicating:
      • Material Name
      • Batch Number
      • Status: “Under Test”

5.2 Updating Material Status

  1. Status Changes:
    • Update material status in the inventory system based on QC results and QA decisions:
      • “Approved” – Materials cleared by QC and QA.
      • “Rejected” – Materials failing QC tests.
      • “Expired” – Materials exceeding shelf-life during quarantine.
      • “Hold” – Materials under investigation or with discrepancies.
    • Document changes in the Material Status Update Log (Annexure-2).
  2. Label Updates:
    • Replace or update labels to reflect the current status of the material:
      • Green Tag: “Approved”
      • Red Tag: “Rejected”
      • Yellow Tag: “Hold”
      • Black Tag: “Expired”

5.3 Documentation Review and Verification

  1. QA Review:
    • QA personnel must review all documentation related to material status weekly.
    • Sign and date reviewed documents, and file them for future reference and audits.
  2. Audit Trail:
    • Ensure all digital updates are logged with timestamps and user identification to maintain traceability.
    • Document any discrepancies in the Quarantine Documentation Discrepancy Report (Annexure-3).
See also  SOP for Handling Suspected Counterfeit or Adulterated Raw Materials - V 2.0

5.4 Handling Documentation Deviations

  1. Deviation Reporting:
    • Report any inconsistencies or errors in documentation to the QA Manager.
    • Document deviations in the Documentation Deviation Report (Annexure-4).
  2. Corrective Actions:
    • Investigate the root cause of deviations and implement corrective measures to prevent recurrence.
    • Document corrective actions in the Corrective Action Log (Annexure-5).

6. Abbreviations

7. Documents

  1. Quarantine Material Log (Annexure-1)
  2. Material Status Update Log (Annexure-2)
  3. Quarantine Documentation Discrepancy Report (Annexure-3)
  4. Documentation Deviation Report (Annexure-4)
  5. Corrective Action Log (Annexure-5)

8. References

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 Material Log

Date of Receipt Material Name Batch Number Supplier GRN Number Initial Status Logged By
01/02/2025 API-X X-2025-001 Supplier A GRN-12345 Under Test Ravi Kumar

Annexure-2: Material Status Update Log

Date Material Name Batch Number Previous Status New Status Updated By Verified By (QA)
03/02/2025 API-X X-2025-001 Under Test Approved Sunita Sharma Anjali Mehta

Annexure-3: Quarantine Documentation Discrepancy Report

Date Material Name Batch Number Discrepancy Description Reported By Corrective Action Taken
04/02/2025 API-X X-2025-001 Incorrect Status in Digital System Ravi Kumar Status Corrected, Training Conducted

Annexure-4: Documentation Deviation Report

Date Deviation Description Reported By Corrective Action Taken Verified By (QA)
05/02/2025 Material Status Not Updated on Time Sunita Sharma System Alerts Implemented Ajay Singh

Annexure-5: Corrective Action Log

Date Issue Corrective Action Responsible Person Follow-Up Required
06/02/2025 Incorrect Documentation Process Updated SOP, Conducted Training 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 Documentation Procedures for Quarantine Materials Regulatory Compliance QA Head
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