SOP Guide for Pharma

SOP for Use of Color-Coded Labels for Material Status Identification – V 2.0

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SOP for Use of Color-Coded Labels for Material Status Identification – V 2.0

Standard Operating Procedure for Use of Color-Coded Labels for Material Status Identification

Department Warehouse / Quality Assurance
SOP No. SOP/RM/105/2025
Supersedes SOP/RM/105/2022
Page No. Page 1 of 15
Issue Date 05/02/2025
Effective Date 09/02/2025
Review Date 05/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the guidelines for using color-coded labels to identify the status of raw materials in the warehouse. The procedure ensures clear, visible differentiation between approved, quarantined, and rejected materials, reducing the risk of mix-ups and maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and chemicals stored in the warehouse. It covers procedures for labeling materials at receipt, during storage, and following status changes.

3. Responsibilities

  • Warehouse Personnel: Apply and maintain color-coded labels on all raw materials, ensuring visibility and accuracy.
  • Quality Assurance (QA): Verify proper use of color-coded labels during audits and inspections. Approve status changes requiring relabeling.
  • Warehouse Manager: Ensure proper training of warehouse staff on color-coded labeling procedures and oversee compliance.

4. Accountability

The Warehouse Manager is accountable for the implementation and accuracy of color-coded labeling. The QA

Manager is responsible for ensuring compliance with GMP and regulatory requirements during audits.
See also  SOP for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials - V 2.0

5. Procedure

5.1 Color-Coding System for Material Status

  1. Approved Materials:
    • Green labels indicate that the material has passed all quality control tests and is approved for use.
    • The label should clearly display “APPROVED” along with essential material information.
  2. Quarantined Materials:
    • Yellow labels signify that the material is under quarantine, awaiting quality control testing or further investigation.
    • The label should display “QUARANTINE” and include relevant details such as batch number and receipt date.
  3. Rejected Materials:
    • Red labels indicate that the material has failed quality control tests and is rejected for use.
    • The label should display “REJECTED” and the reason for rejection, along with other relevant information.

5.2 Labeling Requirements

  1. Label Information:
    • All color-coded labels must include the following:
      • Material Name
      • Batch/Lot Number
      • Supplier Name
      • Manufacturing Date
      • Expiry Date or Retest Date
      • Storage Conditions (if applicable)
      • Status (Approved, Quarantine, Rejected)
  2. Label Placement:
    • Place labels on the front-facing side of the container to ensure visibility.
    • Ensure labels are securely affixed and resistant to damage or peeling during handling and storage.

5.3 Labeling Procedures

  1. Initial Labeling at Receipt:
    • Upon receipt of raw materials, warehouse personnel must apply the appropriate color-coded label based on the initial status (typically Quarantine).
    • Document all labeling activities in the Labeling Log (Annexure-1).
  2. Relabeling Due to Status Changes:
    • When a material’s status changes (e.g., from Quarantine to Approved), replace the existing label with the appropriate color-coded label.
    • Remove or mark obsolete labels to prevent confusion.
    • Document relabeling activities in the Status Change Log (Annexure-2).
See also  SOP for Monitoring Temperature and Humidity in Quarantine Storage - V 2.0

5.4 Handling of Damaged or Illegible Labels

  1. Inspection of Labels:
    • Regularly inspect labels for signs of damage, fading, or illegibility.
    • Report any issues to the Warehouse Manager and QA for corrective action.
  2. Replacement of Labels:
    • Immediately replace any damaged or illegible labels with the correct color-coded label.
    • Document label replacements in the Label Replacement Log (Annexure-3).

5.5 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct periodic inspections to ensure proper use of color-coded labels.
    • Document inspection findings in the Warehouse Inspection Log (Annexure-4).
  2. QA Compliance Audits:
    • QA will perform audits to verify that color-coded labeling complies with GMP and regulatory requirements.
    • Document audit findings in the Compliance Audit Log (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance

7. Documents

  1. Labeling Log (Annexure-1)
  2. Status Change Log (Annexure-2)
  3. Label Replacement Log (Annexure-3)
  4. Warehouse Inspection Log (Annexure-4)
  5. Compliance Audit Log (Annexure-5)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • WHO GMP Guidelines
See also  SOP for Storage Conditions in Quarantine for Different Types of Raw Materials - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Labeling Log

Date Material Name Batch Number Status Labeled By
05/02/2025 API-X API-X-2025-001 Quarantine Ravi Kumar

Annexure-2: Status Change Log

Date Material Name Batch Number Previous Status New Status Changed By
06/02/2025 API-X API-X-2025-001 Quarantine Approved Anjali Mehta

Annexure-3: Label Replacement Log

Date Material Name Batch Number Reason for Replacement Replaced By
07/02/2025 API-X API-X-2025-001 Label Damaged Sunita Sharma

Annexure-4: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
08/02/2025 Raw Material Storage Area Anjali Mehta All labels in compliance N/A

Annexure-5: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
09/02/2025 Color-Coding Compliance Audit 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
05/02/2025 2.0 Updated Labeling Procedures and Documentation Formats Regulatory Compliance QA Head
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