SOP for Ensuring GMP Compliance in Quarantine Operations – V 2.0

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SOP for Ensuring GMP Compliance in Quarantine Operations – V 2.0

Standard Operating Procedure for Ensuring GMP Compliance in Quarantine Operations

Department Quality Assurance / Warehouse / Quality Control
SOP No. SOP/RM/097/2025
Supersedes SOP/RM/097/2022
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) establishes guidelines to ensure Good Manufacturing Practice (GMP) compliance in the management of quarantined raw materials. It outlines procedures for storage, handling, documentation, and release or rejection of materials to maintain product quality and regulatory compliance.

2. Scope

This SOP applies to all raw materials received at the facility that are placed in quarantine pending quality testing and approval. It covers the responsibilities of the Quality Assurance (QA), Warehouse, and Quality Control (QC) teams in maintaining GMP standards during quarantine operations.

3. Responsibilities

  • Warehouse Personnel: Ensure proper receipt, labeling, and storage of quarantined materials as per GMP standards.
  • Quality Assurance (QA): Oversee quarantine operations, ensure GMP compliance, and approve material release or rejection.
  • Quality Control (QC): Conduct sampling and testing of quarantined materials and report results to QA.

4. Accountability

The QA Manager is accountable for ensuring GMP compliance in all quarantine operations, while the Warehouse

Manager is responsible for maintaining proper storage conditions and accurate documentation of quarantined materials.

5. Procedure

5.1 GMP Requirements for Quarantine Management

  1. Facility Design and Layout:
    • Quarantine areas must be clearly demarcated and physically separated from approved and rejected material storage areas.
    • Access to quarantine areas should be restricted to authorized personnel only.
  2. Environmental Controls:
    • Maintain appropriate temperature, humidity, and cleanliness in quarantine areas to prevent material degradation.
    • Document environmental conditions in the Environmental Monitoring Log (Annexure-1).
See also  SOP for Verification of Certificate of Analysis (CoA) During Material Receipt - V 2.0

5.2 Receipt and Quarantine of Raw Materials

  1. Material Receipt and Inspection:
    • Warehouse personnel must inspect incoming raw materials for damages and verify shipment details against purchase orders.
    • Record material details in the Raw Material Receiving Log (Annexure-2).
  2. Quarantine Labeling and Storage:
    • Label all materials with a “QUARANTINE” tag, including:
      • Material Name
      • Batch/Lot Number
      • Date of Receipt
      • Supplier Information
    • Store materials in designated quarantine areas and document storage locations in the Quarantine Material Log (Annexure-3).

5.3 Sampling and Testing Procedures

  1. Sampling Authorization:
    • QA must authorize sampling by completing the Sampling Authorization Form (Annexure-4).
    • QC will coordinate with the Warehouse team to collect samples as per standard protocols.
  2. Testing and Documentation:
    • QC will perform required tests and record results in the Quarantine Testing Log (Annexure-5).
    • Communicate test results to QA for review and approval.

5.4 Material Release and Rejection Process

  1. Material Release Procedure:
    • Upon approval, QA will complete the Material Release Authorization Form (Annexure-6).
    • Warehouse personnel will move released materials to the approved storage area and update the Quarantine Release Log (Annexure-7).
  2. Material Rejection Procedure:
    • For rejected materials, QA will complete the Material Rejection Form (Annexure-8).
    • Warehouse personnel will move rejected materials to the designated rejection area and update the Rejected Material Log (Annexure-9).

5.5 Documentation and Record-Keeping

  1. Record Maintenance:
    • All records related to quarantine operations must be accurate, complete, and maintained as per GMP requirements.
    • Ensure records are reviewed periodically and archived securely in the Quarantine Record Archive (Annexure-10).
See also  SOP for Conducting Initial Inspection of Water-Sensitive Raw Materials - V 2.0

5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All personnel involved in quarantine operations must receive training on GMP requirements and quarantine procedures.
    • Document training sessions in the Training Log (Annexure-11).
  2. GMP Compliance Audits:
    • QA will conduct periodic GMP compliance audits of quarantine operations.
    • Document audit findings in the GMP Compliance Audit Log (Annexure-12).

6. Abbreviations

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

7. Documents

  1. Environmental Monitoring Log (Annexure-1)
  2. Raw Material Receiving Log (Annexure-2)
  3. Quarantine Material Log (Annexure-3)
  4. Sampling Authorization Form (Annexure-4)
  5. Quarantine Testing Log (Annexure-5)
  6. Material Release Authorization Form (Annexure-6)
  7. Quarantine Release Log (Annexure-7)
  8. Material Rejection Form (Annexure-8)
  9. Rejected Material Log (Annexure-9)
  10. Quarantine Record Archive (Annexure-10)
  11. Training Log (Annexure-11)
  12. GMP Compliance Audit Log (Annexure-12)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Temperature (°C) Humidity (%) Recorded By
01/02/2025 22°C 45% Ravi Kumar

Annexure-2: Raw Material Receiving Log

Date Material Name Batch Number Supplier Received By
01/02/2025 API-X API-X-2025-001 Supplier A Sunita Sharma

Annexure-3: Quarantine Material Log

Date Material Name Batch Number Quarantine Location Labeled By
01/02/2025 API-X API-X-2025-001 Quarantine Area 1 Ravi Kumar
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Annexure-4: Sampling Authorization Form

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

Annexure-5: Quarantine Testing Log

Date Material Name Batch Number Test Conducted Result Tested By
03/02/2025 API-X API-X-2025-001 Purity Test Pass Sunita Sharma

Annexure-6: Material Release Authorization Form

Date Material Name Batch Number Released By Signature
04/02/2025 API-X API-X-2025-001 Anjali Mehta

Annexure-7: Quarantine Release Log

Date Material Name Batch Number Released To Released By
04/02/2025 API-X API-X-2025-001 Production Anjali Mehta

Annexure-8: Material Rejection Form

Date Material Name Batch Number Rejected By Reason for Rejection
05/02/2025 API-Y API-Y-2025-002 Anjali Mehta Failed Moisture Test

Annexure-9: Rejected Material Log

Date Material Name Batch Number Rejection Status Handled By
05/02/2025 API-Y API-Y-2025-002 Moved to Rejection Area Ravi Kumar

Annexure-10: Quarantine Record Archive

Date Document Type Archived By Location
06/02/2025 Quarantine Logs Ravi Kumar Archive Room A

Annexure-11: Training Log

Date Training Topic Trainer Attendee Name Signature
07/02/2025 GMP Compliance in Quarantine Operations QA Manager Sunita Sharma

Annexure-12: GMP Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
08/02/2025 GMP Compliance Audit No Major Issues Found N/A 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 GMP Compliance Procedures Regulatory Compliance QA Head
Raw Material Warehouse V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,