SOP Guide for Pharma

SOP for Handling and Disposal of Quarantined Raw Materials Beyond Retention Period – V 2.0

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SOP for Handling and Disposal of Quarantined Raw Materials Beyond Retention Period – V 2.0

Standard Operating Procedure for Handling and Disposal of Quarantined Raw Materials Beyond Retention Period

Department Quality Assurance / Warehouse / Environmental Health & Safety (EHS)
SOP No. SOP/RM/098/2025
Supersedes SOP/RM/098/2022
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 handling and disposing of quarantined raw materials that have exceeded their retention period. It ensures safe disposal, regulatory compliance, and proper documentation to maintain Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in the quarantine area that have not been approved for use and have surpassed their designated retention period. It includes materials awaiting testing, rejected materials, and those requiring special handling.

3. Responsibilities

  • Warehouse Personnel: Identify materials beyond the retention period, label them appropriately, and coordinate with QA and EHS for disposal.
  • Quality Assurance (QA): Approve the disposal of expired quarantined materials, ensure proper documentation, and verify compliance with GMP standards.
  • Environmental Health & Safety (EHS): Oversee the safe disposal of hazardous or environmentally sensitive materials, ensuring compliance with environmental regulations.

4. Accountability

The

QA Manager is accountable for ensuring that all materials exceeding the retention period are identified, documented, and disposed of according to GMP and regulatory requirements. The EHS Manager is responsible for ensuring environmentally safe disposal practices.
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5. Procedure

5.1 Identification of Materials Beyond Retention Period

  1. Monitoring Retention Periods:
    • Warehouse personnel must regularly review the retention dates of quarantined materials.
    • Identify materials that have exceeded their retention period and record them in the Retention Monitoring Log (Annexure-1).
  2. Labeling of Expired Materials:
    • Clearly label materials that have exceeded their retention period with an “EXPIRED – FOR DISPOSAL” tag.
    • Include material name, batch number, date of expiration, and reason for disposal on the label.

5.2 Approval for Disposal

  1. QA Review and Authorization:
    • QA will review the Retention Monitoring Log and verify that materials are beyond the retention period.
    • Complete the Disposal Authorization Form (Annexure-2) and approve materials for disposal.
  2. Documentation of Disposal Approval:
    • Record the approved materials for disposal in the Disposal Approval Log (Annexure-3).

5.3 Disposal Process

  1. Segregation of Materials for Disposal:
    • Warehouse personnel must segregate materials approved for disposal from other quarantined materials.
    • Transfer materials to the designated disposal area within the facility.
  2. Disposal of Non-Hazardous Materials:
    • Non-hazardous materials should be disposed of according to facility waste management protocols.
    • Document disposal activities in the Non-Hazardous Material Disposal Log (Annexure-4).
  3. Disposal of Hazardous Materials:
    • Coordinate with the EHS team for the safe disposal of hazardous or environmentally sensitive materials.
    • Use certified disposal vendors and retain certificates of disposal.
    • Record disposal in the Hazardous Material Disposal Log (Annexure-5).
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5.4 Post-Disposal Documentation

  1. Final Review of Disposal Records:
    • QA will review all disposal records to ensure compliance with SOP and regulatory guidelines.
    • File all records in the Disposal Record Archive (Annexure-6).
  2. Compliance Audits:
    • QA and EHS will conduct periodic audits of the disposal process to ensure compliance with environmental and GMP standards.
    • Document audit findings in the Disposal Compliance Audit Log (Annexure-7).

5.5 Training and Monitoring

  1. Personnel Training:
    • All personnel involved in the disposal process must be trained on handling and disposal procedures.
    • Document training in the Disposal Training Log (Annexure-8).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • EHS: Environmental Health & Safety
  • MSDS: Material Safety Data Sheet

7. Documents

  1. Retention Monitoring Log (Annexure-1)
  2. Disposal Authorization Form (Annexure-2)
  3. Disposal Approval Log (Annexure-3)
  4. Non-Hazardous Material Disposal Log (Annexure-4)
  5. Hazardous Material Disposal Log (Annexure-5)
  6. Disposal Record Archive (Annexure-6)
  7. Disposal Compliance Audit Log (Annexure-7)
  8. Disposal Training 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
  • OSHA Guidelines for the Disposal of Hazardous Waste

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

See also  SOP for Receiving and Managing Multiple Batches of the Same Raw Material - V 2.0

Annexure-1: Retention Monitoring Log

Date Material Name Batch Number Retention Period Identified By
01/02/2025 API-X API-X-2024-001 12 Months Ravi Kumar

Annexure-2: Disposal Authorization Form

Date Material Name Batch Number Authorized By Signature
02/02/2025 API-X API-X-2024-001 Anjali Mehta

Annexure-3: Disposal Approval Log

Date Material Name Batch Number Approved By Disposed By
03/02/2025 API-X API-X-2024-001 Anjali Mehta Ravi Kumar

Annexure-4: Non-Hazardous Material Disposal Log

Date Material Name Batch Number Disposal Method Disposed By
04/02/2025 Excipent-Y EXC-Y-2024-002 Incineration Warehouse Team

Annexure-5: Hazardous Material Disposal Log

Date Material Name Batch Number Disposal Vendor Certificate No.
05/02/2025 Solvent-Z SLV-Z-2024-003 Safe Waste Disposal Ltd. SWDL-2025-0098

Annexure-6: Disposal Record Archive

Date Document Type Archived By Location
06/02/2025 Disposal Logs Sunita Sharma Archive Room B

Annexure-7: Disposal Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
07/02/2025 Disposal Process Audit No Issues Found N/A Anjali Mehta

Annexure-8: Disposal Training Log

Date Training Topic Trainer Attendee Name Signature
08/02/2025 Safe Disposal of Quarantined Materials EHS Manager Ravi Kumar

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 Disposal Procedures and Documentation Formats Regulatory Compliance QA Head
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