SOP Guide for Pharma

SOP for Immediate Quarantine of Raw Materials Suspected of Contamination – V 2.0

SOP for Immediate Quarantine of Raw Materials Suspected of Contamination – V 2.0

Standard Operating Procedure for Immediate Quarantine of Raw Materials Suspected of Contamination

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/043/2025
Supersedes SOP/RM/043/2022
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 immediate actions required for the quarantine of raw materials suspected of contamination. The prompt and systematic quarantine of such materials is critical to prevent cross-contamination, ensure product safety, and maintain regulatory compliance. This SOP ensures:

2. Scope

This SOP applies to all raw materials received at the facility that show signs of contamination or are suspected of contamination during transport, receipt, or storage. It includes:

3. Responsibilities

4. Accountability

The Warehouse Manager is responsible for the immediate segregation and quarantine of suspected contaminated materials. The QA Manager holds the authority to investigate contamination incidents, coordinate corrective actions, and approve or reject materials based on contamination assessments. The QC Manager is responsible for testing and confirming contamination in raw materials.

5. Procedure

5.1 Identification of Suspected Contamination

  1. Inspection During Material Receipt
    1. Warehouse personnel inspect raw materials upon receipt for the following signs of contamination:
      • Damaged, punctured, or leaking packaging.
      • Presence of foreign particles, discoloration, or unusual odors.
      • Evidence of pest infestation (e.g., insect activity, rodent droppings).
      • Temperature excursions that may compromise material integrity.
    2. Document any suspected contamination in the Raw Material Receiving Register (Annexure-1).
  2. Immediate Notification to QA and QC
    1. Immediately notify QA and QC teams of any suspected contamination.
    2. Do not proceed with any further handling of the suspected materials until QA approval.

5.2 Segregation and Quarantine of Suspected Materials

  1. Labeling and Segregation
    1. Label suspected contaminated materials with a “QUARANTINED – SUSPECTED CONTAMINATION” tag.
    2. Segregate the materials from other raw materials and move them to the designated quarantine area.
    3. Ensure that the quarantine area is clearly marked, secure, and prevents cross-contamination.
  2. Quarantine Documentation
    1. Document the quarantine details in the Quarantine Log (Annexure-3), including:
      • Material name, batch number, and supplier details.
      • Date and time of quarantine.
      • Reason for quarantine and initial observations.

5.3 Investigation and Testing of Contaminated Materials

  1. Initiation of Contamination Report
    1. QA initiates a Contamination Report (Annexure-2) based on the notification from the Warehouse team.
    2. Document the suspected contamination details, including:
      • Material and batch information.
      • Nature of the suspected contamination.
      • Initial observations and personnel involved in the receipt process.
  2. Sampling and Testing by QC
    1. QC personnel collect samples from the quarantined materials following contamination control protocols.
    2. Conduct laboratory testing to confirm the presence and type of contamination, including:
      • Microbiological testing for bacterial or fungal contamination.
      • Chemical analysis for unexpected substances or impurities.
      • Physical testing for foreign particles or material degradation.
    3. Document testing results in the Contamination Report and Sampling Log (Annexure-1).

5.4 Final Disposition of Quarantined Materials

  1. Approval or Rejection of Materials
    1. QA reviews testing results and contamination reports to determine the final disposition of the quarantined materials:
      • If materials are confirmed free of contamination, label them “APPROVED” and move them to storage.
      • If contamination is confirmed, label materials “REJECTED” and move them to the rejection area.
  2. Supplier Notification and Corrective Actions
    1. Procurement notifies the supplier of contamination findings and requests corrective actions.
    2. Ensure that suppliers investigate the root cause of contamination and implement preventive measures.

6. Abbreviations

7. Documents

  1. Raw Material Receiving Register (Annexure-1)
  2. Contamination Report (Annexure-2)
  3. Quarantine Log (Annexure-3)
  4. Supplier Communication and Corrective Action Records

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: Raw Material Receiving Register

Date Supplier Name Material Name Batch Number PO Number Inspection Findings Quarantine Status Remarks
01/02/2025 ABC Chemicals API-X X-2025-001 PO-12345 Punctured Packaging Quarantined Pending QA Review
02/02/2025 XYZ Pharma Excipient-Y Y-2025-002 PO-67890 Foreign Particles Detected Quarantined QC Testing in Progress

Annexure-2: Contamination Report

Report Number Date Material Name Batch Number Type of Contamination Testing Results Final Disposition Remarks
CON-001/2025 01/02/2025 API-X X-2025-001 Packaging Damage No Contamination Detected Approved Moved to Storage
CON-002/2025 02/02/2025 Excipient-Y Y-2025-002 Foreign Particles Contamination Confirmed Rejected Supplier Notified

Annexure-3: Quarantine Log

Date Material Name Batch Number Reason for Quarantine QA Approval Date Final Disposition Remarks
01/02/2025 API-X X-2025-001 Punctured Packaging 03/02/2025 Approved Released to Storage
02/02/2025 Excipient-Y Y-2025-002 Foreign Particles 04/02/2025 Rejected Returned to Supplier

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 1.0 Initial Version New SOP Creation QA Head All All Established procedures for immediate quarantine of suspected contaminated raw materials.
01/02/2025 2.0 Added Detailed Investigation and Supplier Notification Process Standardization of Document QA Head All All Enhanced documentation and corrective action steps for contamination management.
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