SOP Guide for Pharma

SOP for Segregation of Approved, Rejected, and Quarantined Raw Materials – V 2.0

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SOP for Segregation of Approved, Rejected, and Quarantined Raw Materials – V 2.0

Standard Operating Procedure for Segregation of Approved, Rejected, and Quarantined Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/103/2025
Supersedes SOP/RM/103/2022
Page No. Page 1 of 15
Issue Date 03/02/2025
Effective Date 07/02/2025
Review Date 03/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for segregating approved, rejected, and quarantined raw materials in the warehouse to prevent cross-contamination, ensure material integrity, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals. It covers procedures for physical segregation, labeling, documentation, and handling of different material statuses.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for implementing and maintaining segregation practices. The QA Manager is responsible for verifying compliance with GMP requirements through audits and documentation reviews.

See also  SOP for Prevention of Cross-Contamination in Raw Material Storage - V 2.0

5. Procedure

5.1 Material Status Classification

  1. Approved Materials:
    • Materials that have passed quality control testing and are cleared for use in production.
    • Labeled with green tags indicating “APPROVED.”
  2. Quarantined Materials:
    • Materials awaiting quality control testing or under investigation.
    • Labeled with yellow tags indicating “QUARANTINE.”
  3. Rejected Materials:
    • Materials that have failed quality control testing or do not meet specifications.
    • Labeled with red tags indicating “REJECTED.”

5.2 Segregation of Materials

  1. Physical Segregation:
    • Store approved, quarantined, and rejected materials in clearly marked, physically separated areas within the warehouse.
    • Use barriers, color-coded floor markings, or dedicated rooms to prevent mix-ups.
  2. Environmental Controls:
    • Ensure that segregated areas maintain appropriate temperature, humidity, and other environmental conditions as required.
    • Document environmental conditions in the Storage Conditions Log (Annexure-1).

5.3 Labeling and Documentation

  1. Labeling Requirements:
    • All materials must be clearly labeled with:
      • Material Name
      • Batch Number
      • Status (Approved, Quarantine, Rejected)
      • Storage Conditions (if applicable)
    • Document labeling activities in the Labeling Log (Annexure-2).
  2. Status Change Documentation:
    • Any change in material status (e.g., from Quarantine to Approved) must be documented in the Status Change Log (Annexure-3).
    • QA approval is required for all status changes.

See also  SOP for Reviewing and Updating Quarantine Procedures Based on Regulatory Changes - V 2.0

5.4 Handling of Rejected Materials

  1. Storage of Rejected Materials:
    • Store rejected materials in a separate, secure area labeled “REJECTED MATERIALS.”
    • Ensure rejected materials are not accessible for production use.
  2. Disposal of Rejected Materials:
    • Coordinate with QA and Environmental Health & Safety (EHS) teams for proper disposal of rejected materials.
    • Document disposal activities in the Rejected Material Disposal Log (Annexure-4).

5.5 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct regular inspections to ensure proper segregation and labeling of materials.
    • Record inspection findings in the Warehouse Inspection Log (Annexure-5).
  2. QA Compliance Audits:
    • QA will conduct periodic audits to verify compliance with segregation procedures.
    • Document audit findings in the Compliance Audit Log (Annexure-6).

6. Abbreviations

7. Documents

  1. Storage Conditions Log (Annexure-1)
  2. Labeling Log (Annexure-2)
  3. Status Change Log (Annexure-3)
  4. Rejected Material Disposal Log (Annexure-4)
  5. Warehouse Inspection Log (Annexure-5)
  6. Compliance Audit Log (Annexure-6)

8. References

9. SOP Version

Version: 2.0

See also  SOP for Handling and Storage of Liquid Raw Materials in Bulk Containers - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Storage Conditions Log

Date Storage Area Temperature (°C) Humidity (%) Recorded By
03/02/2025 Approved Materials Area 22°C 45% Ravi Kumar

Annexure-2: Labeling Log

Date Material Name Batch Number Status Labeled By
03/02/2025 API-X API-X-2025-001 Approved Sunita Sharma

Annexure-3: Status Change Log

Date Material Name Batch Number Previous Status New Status Approved By
04/02/2025 Excipent-Y EX-Y-2024-002 Quarantine Approved Anjali Mehta

Annexure-4: Rejected Material Disposal Log

Date Material Name Batch Number Disposal Method Disposed By
05/02/2025 API-Y API-Y-2025-003 Incineration Ravi Kumar

Annexure-5: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
06/02/2025 Quarantine Area Anjali Mehta No issues found N/A

Annexure-6: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
07/02/2025 Segregation Compliance Audit All procedures compliant 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
03/02/2025 2.0 Updated Segregation Procedures and Documentation Formats Regulatory Compliance QA Head
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