Elixir Department: SOP for Segregation of Quarantined and Approved Materials – V 2.0

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Elixir Department: SOP for Segregation of Quarantined and Approved Materials – V 2.0

Standard Operating Procedure for Segregation of Quarantined and Approved Materials in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/034/2025
Supersedes SOP/ELX/034/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP outlines the procedure for physical and systemic segregation of quarantined and approved raw materials to avoid cross-contamination, mix-ups, and ensure compliance with GMP regulations within the Elixir Department.

2. Scope

This SOP applies to all raw materials, excipients, solvents, and APIs received in the warehouse of the Elixir Department, covering quarantine, sampling, approval, rejection, and movement controls.

3. Responsibilities

  • Warehouse Personnel:
    • Store materials as per their status (Quarantine/Approved/Rejected).
    • Ensure area-wise segregation and accurate labeling.
  • QC Department:
    • Sample and analyze materials and assign approval or rejection status.
  • QA Department:
    • Verify segregation and maintain records of material status updates.

4. Accountability

The Warehouse In-Charge is accountable for ensuring proper segregation and record maintenance of quarantined and approved materials as per GMP norms.

See also  Elixir Department: SOP for Dispensing Solvents and Vehicles - V 2.0

5. Procedure

5.1 Material

Receipt and Initial Quarantine
  1. Upon receipt of raw materials, verify the delivery against the purchase order and generate a Goods Receipt Note (GRN).
  2. Label each container with a “Quarantine” tag (red color) and transfer it to the designated quarantine area.
  3. Record material entry in the inventory management system with “Quarantine” status.

5.2 Sampling and Quality Control

  1. QC shall perform sampling as per the sampling SOP using appropriate tools and under controlled conditions.
  2. Retain samples, test the material, and generate the Certificate of Analysis (CoA).
  3. Based on test results, update material status in the system as either “Approved” (green label) or “Rejected” (yellow label).

5.3 Area Segregation

  1. Maintain dedicated areas with physical barriers or designated zones for:
    • Quarantine Materials
    • Approved Materials
    • Rejected Materials
  2. Ensure materials from different status categories are never stored together or transferred without authorization.
  3. Post signage and access control measures for each area.

5.4 Material Movement and Traceability

  1. Allow transfer of “Approved” materials only after QA clearance for dispensing or production use.
  2. Update inventory status and movement logs for each container movement.
  3. Rejected materials shall be moved to the “Rejected” storage area with documentation and root cause analysis initiated.

5.5 Labeling Guidelines

  1. Each container shall carry a status-specific label:
    • Red Label: Quarantine – Under QC Review
    • Green Label: Approved – Released for Use
    • Yellow Label: Rejected – Not to be Used
  2. Labels must include material name, batch number, status, date, and authorized signatory.

5.6 Documentation and Record Keeping

  1. Maintain all entries in the Material Dispensing Log (Annexure-1) and attach test reports (Annexure-2).
  2. Complete Approval and Release Form (Annexure-3) and archive in QA records.

6. Abbreviations

  • QC: Quality Control
  • QA: Quality Assurance
  • GRN: Goods Receipt Note
  • SOP: Standard Operating Procedure
  • CoA: Certificate of Analysis

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)

8. References

  • WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
  • 21 CFR Part 211 – Current Good Manufacturing Practice
  • EU GMP Guide – Chapter 5: Production

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Batch No. Status Location Handled By
11/04/2025 Sodium Benzoate SB0021 Quarantine Zone Q2 Rajesh Kumar
11/04/2025 Citric Acid CA1199 Approved Zone A1 Sunita Reddy

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Complies
Citric Acid CA1199 Assay 99.6% Yes

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Status
11/04/2025 Citric Acid CA1199 Ajay Mehta Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New Document Creation QA Head
11/04/2025 2.0 Format Updated, Color Coding Clarified GMP Compliance and Warehouse Audit Findings QA Head
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