SOP for Transporting Rejected Raw Materials from Quarantine to Disposal Area – V 2.0

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SOP for Transporting Rejected Raw Materials from Quarantine to Disposal Area – V 2.0

Standard Operating Procedure for Transporting Rejected Raw Materials from Quarantine to Disposal Area

Department Quality Assurance / Warehouse / Quality Control
SOP No. SOP/RM/092/2025
Supersedes SOP/RM/092/2022
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 transporting rejected raw materials from the quarantine area to the designated disposal area. The procedure ensures that rejected materials are handled, transported, and disposed of in compliance with Good Manufacturing Practices (GMP) and environmental regulations.

2. Scope

This SOP applies to all rejected raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, stored in quarantine and designated for disposal.

3. Responsibilities

  • Warehouse Personnel: Label, secure, and transport rejected materials following approved protocols.
  • Quality Assurance (QA): Approve the rejection, oversee the transportation process, and ensure documentation is complete.
  • Quality Control (QC): Provide testing results leading to the rejection of materials and support the transportation process if required.

4. Accountability

The QA Manager is accountable for ensuring that rejected materials are transported and disposed of in compliance with regulatory and environmental guidelines. The Warehouse Manager is responsible for coordinating the safe handling and movement of these materials.

5. Procedure

5.1 Identification and Documentation of Rejected Materials

  1. Approval of Rejection:
    • QA reviews QC test results and documentation before approving the rejection of materials.
    • The Material Rejection Authorization Form (Annexure-1) must be completed and signed by QA.
  2. Labeling of Rejected Materials:
    • Warehouse personnel must label rejected materials with:
      • “REJECTED” tag in red
      • Material Name and Batch/Lot Number
      • Reason for Rejection
      • Date of Rejection
    • Ensure all labels are clear, legible, and securely attached to the material containers.
See also  SOP for Transporting Raw Materials from Receiving Area to Quarantine - V 2.0

5.2 Preparation for Transportation

  1. Securing Rejected Materials:
    • Ensure all containers are sealed, intact, and free from leaks or damage before transportation.
    • For hazardous materials, follow safety protocols, including the use of personal protective equipment (PPE) and proper containment measures.
  2. Transport Authorization:
    • Complete the Rejected Material Transport Authorization Form (Annexure-2) and obtain signatures from the QA Manager and Warehouse Manager.

5.3 Transporting Rejected Materials

  1. Designated Disposal Route:
    • Transport rejected materials using the designated route from the quarantine area to the disposal area.
    • Ensure the route is free from obstructions and complies with safety regulations.
  2. Use of Appropriate Equipment:
    • Use forklifts, trolleys, or other appropriate equipment to move rejected materials safely.
    • Ensure all equipment is in good working condition and suitable for transporting the specific material type.

5.4 Documentation and Record-Keeping

  1. Transport Logs:
    • Record all transportation activities in the Rejected Material Transport Log (Annexure-3), including:
      • Date and Time of Transport
      • Material Name and Batch/Lot Number
      • Transport Personnel
      • Receiving Personnel at Disposal Area
  2. Final Disposal Documentation:
    • Complete the Rejected Material Disposal Record (Annexure-4) once materials have been transported and accepted in the disposal area.
    • QA must verify and sign off on the disposal records.
See also  SOP for Storage Conditions in Quarantine for Different Types of Raw Materials - V 2.0

5.5 Handling Special Categories of Rejected Materials

  1. Hazardous Materials:
    • Follow environmental and safety regulations for the handling and disposal of hazardous materials.
    • Ensure the use of appropriate PPE and containment measures during transportation.
  2. Temperature-Sensitive Materials:
    • Maintain cold chain requirements for temperature-sensitive rejected materials until final disposal.
    • Record temperature data in the Temperature Monitoring Log (Annexure-5).

5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All personnel involved in the transportation of rejected materials must be trained in handling procedures and safety protocols.
    • Document training sessions in the Training Log (Annexure-6).
  2. Compliance Monitoring:
    • QA conducts periodic audits to ensure compliance with SOPs and regulatory requirements.
    • Document audit findings in the Compliance Audit Log (Annexure-7).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • PPE: Personal Protective Equipment
  • APIs: Active Pharmaceutical Ingredients

7. Documents

  1. Material Rejection Authorization Form (Annexure-1)
  2. Rejected Material Transport Authorization Form (Annexure-2)
  3. Rejected Material Transport Log (Annexure-3)
  4. Rejected Material Disposal Record (Annexure-4)
  5. Temperature Monitoring Log (Annexure-5)
  6. Training Log (Annexure-6)
  7. Compliance Audit 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
  • WHO GMP Guidelines for Storage and Disposal of Pharmaceuticals

9. SOP Version

Version: 2.0

See also  SOP for Checking Batch Number, Manufacturing Date, and Expiry Date at Receipt - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Rejection Authorization Form

Date Material Name Batch Number Reason for Rejection Approved By
01/02/2025 API-X API-X-2025-001 Failed Purity Test Anjali Mehta

Annexure-2: Rejected Material Transport Authorization Form

Date Material Name Batch Number Transported By Approved By (QA)
02/02/2025 API-X API-X-2025-001 Ravi Kumar Anjali Mehta

Annexure-3: Rejected Material Transport Log

Date Material Name Batch Number Transported By Received By (Disposal)
02/02/2025 API-X API-X-2025-001 Ravi Kumar Ajay Singh

Annexure-4: Rejected Material Disposal Record

Date Material Name Batch Number Disposed By Verified By (QA)
03/02/2025 API-X API-X-2025-001 Disposal Team Anjali Mehta

Annexure-5: Temperature Monitoring Log

Date Material Name Batch Number Temperature Recorded Recorded By
02/02/2025 Solvent-Y SLV-Y-2025-002 5°C Sunita Sharma

Annexure-6: Training Log

Date Training Topic Trainer Attendee Name Signature
05/02/2025 Handling and Transporting Rejected Materials QA Manager Ravi Kumar

Annexure-7: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
06/02/2025 Transport Compliance Audit Minor Labeling Errors Found Updated Labeling Procedures Anjali Mehta

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 Transport and Disposal Procedures Regulatory Compliance QA Head
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