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:

• Immediate identification, segregation, and quarantine of potentially contaminated raw materials.
• Systematic documentation and reporting of contamination incidents.
• Timely investigation and corrective actions to address contamination risks.
• Compliance with Good Manufacturing Practices (GMP) and regulatory requirements for contamination control.

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:

• Procedures for identifying and quarantining contaminated raw materials.
• Responsibilities of Warehouse, Quality Assurance (QA), and Quality Control (QC) teams in contamination management.
• Documentation, investigation, and corrective actions related to contamination incidents.

3. Responsibilities

• Warehouse Personnel:
  • Inspect raw materials upon receipt and identify any signs of contamination (e.g., damaged packaging, discoloration, foreign particles).
  • Immediately segregate and move suspected contaminated materials to the designated quarantine area.
  • Document the incident in the Raw Material Receiving Register (Annexure-1) and notify QA and QC teams.
• Quality Assurance (QA) Team:
  • Review and verify contamination reports from the Warehouse team.
  • Initiate a Contamination Report (Annexure-2) and coordinate the investigation of the incident.
  • Approve or reject quarantined materials based on the investigation results.
• Quality Control (QC) Team:
  • Conduct sampling and laboratory testing of suspected contaminated materials to confirm contamination.
  • Provide analytical data to support QA in determining the final disposition of quarantined materials.

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

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PO: Purchase Order

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

• 21 CFR Part 211 – Current GMP for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Company-Specific Quality and Contamination Control Policies

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.