SOP for Coordination Between QA and Warehouse Teams for Quarantine Management – V 2.0

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SOP for Coordination Between QA and Warehouse Teams for Quarantine Management – V 2.0

Standard Operating Procedure for Coordination Between QA and Warehouse Teams for Quarantine Management

Department Quality Assurance / Warehouse
SOP No. SOP/RM/096/2025
Supersedes SOP/RM/096/2022
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 a structured approach for effective coordination between the Quality Assurance (QA) and Warehouse teams to ensure proper management of quarantined raw materials. It outlines roles, communication protocols, and procedures for material handling, testing, release, and documentation.

2. Scope

This SOP applies to all raw materials received at the facility that are placed in quarantine pending quality testing and approval. It includes the processes of receiving, labeling, sampling, testing, releasing, and disposing of quarantined materials.

3. Responsibilities

  • Warehouse Personnel: Receive, label, store, and maintain quarantined materials. Ensure accurate documentation and timely communication with QA.
  • Quality Assurance (QA): Oversee the quarantine process, approve sampling and testing, authorize material release or rejection, and ensure compliance with regulatory guidelines.
  • Quality Control (QC): Conduct sampling and testing of quarantined materials as per QA’s direction and report results back to QA and Warehouse.

4. Accountability

The QA Manager

is accountable for the release or rejection of quarantined materials, ensuring that all processes comply with regulatory requirements. The Warehouse Manager is responsible for the proper storage and handling of materials and maintaining accurate records.

5. Procedure

5.1 Material Receipt and Quarantine Placement

  1. Receiving Raw Materials:
    • Warehouse personnel will receive raw materials, verify shipment details against purchase orders, and inspect for damages.
    • Record material details in the Raw Material Receiving Log (Annexure-1).
  2. Quarantine Labeling and Storage:
    • All materials must be labeled with a “QUARANTINE” tag, including:
      • Material Name
      • Batch/Lot Number
      • Date of Receipt
      • Supplier Information
    • Store quarantined materials in designated quarantine storage areas, separate from approved or rejected materials.
    • Document the storage location in the Quarantine Material Log (Annexure-2).
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5.2 Sampling and Testing Coordination

  1. QA Authorization for Sampling:
    • QA will authorize sampling by completing the Sampling Authorization Form (Annexure-3).
    • Warehouse will coordinate with QC to facilitate the sampling process.
  2. QC Sampling and Testing:
    • QC will collect samples and conduct required tests as per standard protocols.
    • Record sampling details in the Quarantine Sampling Log (Annexure-4).
  3. Communication of Results:
    • QC will submit test results to QA for review.
    • QA will communicate approval or rejection decisions to the Warehouse team for further action.

5.3 Material Release or Rejection Process

  1. Material Release Procedure:
    • Upon approval, QA will complete the Material Release Authorization Form (Annexure-5).
    • Warehouse personnel will move released materials to the approved storage area and update the Quarantine Release Log (Annexure-6).
  2. Material Rejection Procedure:
    • For rejected materials, QA will complete the Material Rejection Form (Annexure-7).
    • Warehouse will move rejected materials to the designated rejection area and update the Rejected Material Log (Annexure-8).

5.4 Regular Communication and Review

  1. Weekly Coordination Meetings:
    • QA and Warehouse teams will conduct weekly meetings to review the status of quarantined materials, pending test results, and any issues in the quarantine process.
    • Document meeting outcomes in the Quarantine Coordination Meeting Log (Annexure-9).
  2. Review of Quarantine Records:
    • QA will perform periodic reviews of quarantine records to ensure compliance and accuracy.
    • Document findings in the Quarantine Record Review Log (Annexure-10).
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5.5 Documentation and Record-Keeping

  1. Record Maintenance:
    • All records related to quarantine management must be maintained in compliance with regulatory requirements.
    • Ensure all documentation is reviewed and archived appropriately in the Quarantine Record Archive (Annexure-11).

5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All QA and Warehouse personnel must receive training on quarantine procedures, documentation, and regulatory compliance.
    • Document training sessions in the Training Log (Annexure-12).
  2. Compliance Audits:
    • QA will conduct periodic audits of quarantine management processes to ensure ongoing compliance.
    • Document audit findings in the Compliance Audit Log (Annexure-13).

6. Abbreviations

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

7. Documents

  1. Raw Material Receiving Log (Annexure-1)
  2. Quarantine Material Log (Annexure-2)
  3. Sampling Authorization Form (Annexure-3)
  4. Quarantine Sampling Log (Annexure-4)
  5. Material Release Authorization Form (Annexure-5)
  6. Quarantine Release Log (Annexure-6)
  7. Material Rejection Form (Annexure-7)
  8. Rejected Material Log (Annexure-8)
  9. Quarantine Coordination Meeting Log (Annexure-9)
  10. Quarantine Record Review Log (Annexure-10)
  11. Quarantine Record Archive (Annexure-11)
  12. Training Log (Annexure-12)
  13. Compliance Audit Log (Annexure-13)

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: Raw Material Receiving Log

Date Material Name Batch Number Supplier Received By
01/02/2025 API-X API-X-2025-001 Supplier A Ravi Kumar
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Annexure-2: Quarantine Material Log

Date Material Name Batch Number Quarantine Location Labeled By
01/02/2025 API-X API-X-2025-001 Quarantine Area 1 Sunita Sharma

Annexure-3: Sampling Authorization Form

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

Annexure-4: Quarantine Sampling Log

Date Material Name Batch Number Sampled By Test Conducted Result
03/02/2025 API-X API-X-2025-001 Ravi Kumar Purity Test Pass

Annexure-5: Material Release Authorization Form

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

Annexure-6: 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-7: 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-8: 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-9: Quarantine Coordination Meeting Log

Date Meeting Participants Discussion Points Action Items
06/02/2025 Anjali Mehta, Ravi Kumar Review of Pending Quarantine Materials Follow-up on Testing for API-Z

Annexure-10: Quarantine Record Review Log

Date Reviewed By Findings Corrective Actions
07/02/2025 Anjali Mehta Minor Documentation Errors Corrected by 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 GMP Compliance Procedures Regulatory Compliance QA Head
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