SOP Guide for Pharma

SOP for Use of ‘Under Test’ Labels on Quarantined Materials – V 2.0

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SOP for Use of ‘Under Test’ Labels on Quarantined Materials – V 2.0

Standard Operating Procedure for Use of ‘Under Test’ Labels on Quarantined Materials

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/063/2025
Supersedes SOP/RM/063/2022
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 process for the proper use of ‘Under Test’ labels on quarantined raw materials. It ensures materials are clearly identified, tracked, and managed according to Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, that are placed in quarantine awaiting Quality Control (QC) testing and Quality Assurance (QA) review.

3. Responsibilities

  • Warehouse Personnel: Apply ‘Under Test’ labels on all quarantined materials immediately upon receipt and ensure they are updated after testing.
  • Quality Control (QC) Personnel: Verify the status of materials before and after testing, and update label status if required.
  • Quality Assurance (QA): Review labeling for accuracy and ensure compliance with labeling standards.

4. Accountability

The Warehouse Manager is responsible for ensuring that ‘Under Test’ labels are correctly applied to quarantined materials. The QC Manager ensures that

label status accurately reflects the testing phase, while the QA Manager ensures compliance with regulatory labeling standards.
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5. Procedure

5.1 Preparation of ‘Under Test’ Labels

  1. Label Format:
    • ‘Under Test’ labels must be:
      • Yellow in color for easy identification.
      • Durable and resistant to moisture and chemicals.
      • Clearly printed with legible information.
    • Information on the label must include:
      • ‘UNDER TEST’ in bold letters.
      • Material Name and Code.
      • Batch/Lot Number.
      • GRN Number.
      • Date of Receipt.
      • Signature of the person labeling the material.
  2. Label Availability:
    • Ensure that sufficient pre-printed ‘Under Test’ labels are available in the warehouse.
    • Store unused labels in a controlled environment to prevent damage.

5.2 Application of ‘Under Test’ Labels

  1. Labeling Upon Receipt:
    • Immediately upon receipt, apply the ‘Under Test’ label to the outermost packaging of the material.
    • Ensure labels are securely attached and clearly visible.
    • Record the labeling in the ‘Under Test’ Labeling Log (Annexure-1).
  2. Labeling for Bulk Shipments:
    • For materials in bulk containers (drums, bags, carboys), apply labels to each individual container.

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5.3 Monitoring and Updating ‘Under Test’ Labels

  1. Pre-Sampling Verification:
    • QC personnel must verify the presence and accuracy of ‘Under Test’ labels before sampling.
    • Any discrepancies must be reported to QA immediately.
  2. Post-Testing Updates:
    • After QC testing, update the label to reflect the material’s status:
      • Green Label: Approved.
      • Red Label: Rejected.
    • Ensure all status changes are documented in the Label Status Update Log (Annexure-2).

5.4 Handling Damaged or Missing Labels

  1. Identification and Reporting:
    • If labels are found to be damaged or missing, report to QA immediately.
    • Segregate the affected material and do not proceed with further processing until re-labeled and verified.
  2. Re-labeling Procedure:
    • QA must authorize re-labeling and verify the information against original documentation before applying a new label.
    • Document the incident and re-labeling in the Label Incident Report (Annexure-3).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • GRN: Goods Receipt Note

7. Documents

  1. ‘Under Test’ Labeling Log (Annexure-1)
  2. Label Status Update Log (Annexure-2)
  3. Label Incident Report (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: ‘Under Test’ Labeling Log

Date Material Name Batch Number GRN Number Labeled By Remarks
01/02/2025 API-X X-2025-001 GRN-1001 Ravi Kumar Label Applied Successfully
01/02/2025 Excipient-Y Y-2025-002 GRN-1002 Sunita Sharma No Issues Observed

Annexure-2: Label Status Update Log

Date Material Name Batch Number Previous Status New Status Updated By Remarks
03/02/2025 API-X X-2025-001 Under Test Approved Priya Desai Material Passed QC
03/02/2025 Excipient-Y Y-2025-002 Under Test Rejected Ajay Singh Failed Purity Test

Annexure-3: Label Incident Report

Date Material Name Batch Number Incident Description Reported By Corrective Action Taken
02/02/2025 Excipient-Y Y-2025-002 Label Missing Ravi Kumar Re-labeled After QA Verification

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 Enhanced Labeling Procedures and Documentation Requirements Compliance Improvement QA Head
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