SOP Guide for Pharma

SOP for Labeling Requirements for Raw Materials in Warehouse – V 2.0

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SOP for Labeling Requirements for Raw Materials in Warehouse – V 2.0

Standard Operating Procedure for Labeling Requirements for Raw Materials in Warehouse

Department Warehouse / Quality Assurance
SOP No. SOP/RM/104/2025
Supersedes SOP/RM/104/2022
Page No. Page 1 of 15
Issue Date 04/02/2025
Effective Date 08/02/2025
Review Date 04/02/2026

1. Purpose

This Standard Operating Procedure (SOP) defines the labeling requirements for raw materials stored in the warehouse. It ensures proper identification, traceability, and compliance with Good Manufacturing Practices (GMP) to prevent mix-ups and cross-contamination.

2. Scope

This SOP applies to all raw materials received and stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals. It covers labeling standards, color codes, and documentation procedures.

3. Responsibilities

  • Warehouse Personnel: Ensure all raw materials are accurately labeled upon receipt and throughout storage. Maintain labeling records.
  • Quality Assurance (QA): Verify labeling compliance during audits and inspections. Approve changes in labeling formats.
  • Warehouse Manager: Supervise labeling practices, ensure training of warehouse staff, and address labeling discrepancies.

4. Accountability

The Warehouse Manager is accountable for ensuring all raw materials are properly labeled in accordance with this SOP. The QA Manager is responsible for verifying labeling compliance during audits.

See also  SOP for Sampling Frequency and Criteria for Raw Materials in Quarantine - V 2.0

5. Procedure

5.1 Labeling Requirements

  1. Information to be Included on Labels:
    • Material Name
    • Batch/Lot Number
    • Supplier Name
    • Manufacturing Date
    • Expiry Date or Retest Date
    • Storage Conditions (if applicable)
    • Status (Approved, Quarantined, Rejected)
  2. Label Placement:
    • Labels must be securely affixed to each container in a visible location.
    • Ensure that labels are not damaged, obscured, or detached during handling and storage.

5.2 Color-Coding of Labels

  1. Approved Materials:
    • Green labels indicating “APPROVED.”
  2. Quarantined Materials:
    • Yellow labels indicating “QUARANTINE.”
  3. Rejected Materials:
    • Red labels indicating “REJECTED.”

5.3 Labeling Procedures

  1. Initial Labeling at Receipt:
    • Upon receipt, warehouse personnel must label all raw materials with the required information and status.
    • Document 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), update the label accordingly.
    • Ensure old labels are removed or clearly marked as obsolete.
    • Document relabeling activities in the Status Change Log (Annexure-2).

See also  SOP for Storage of APIs Under Controlled Conditions - V 2.0

5.4 Handling of Damaged or Illegible Labels

  1. Inspection of Labels:
    • Warehouse personnel must regularly inspect labels for damage or illegibility.
    • Report any discrepancies to the Warehouse Manager and QA.
  2. Replacement of Labels:
    • Replace damaged or illegible labels immediately, ensuring the correct information is applied.
    • Document label replacements in the Label Replacement Log (Annexure-3).

5.5 Periodic Review and Compliance Monitoring

  1. Warehouse Inspections:
    • Conduct periodic inspections to verify correct labeling of all materials.
    • Record inspection findings in the Warehouse Inspection Log (Annexure-4).
  2. QA Compliance Audits:
    • QA will conduct periodic audits to ensure labeling practices meet GMP standards.
    • 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

9. SOP Version

Version: 2.0

See also  SOP for Use of Cold Storage Units for Sensitive Raw Materials - V 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
04/02/2025 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
05/02/2025 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
06/02/2025 API-X API-X-2025-001 Damaged Label Sunita Sharma

Annexure-4: Warehouse Inspection Log

Date Area Inspected Inspector Findings Corrective Actions
07/02/2025 Raw Material Storage Area Anjali Mehta All labels intact N/A

Annexure-5: Compliance Audit Log

Date Audit Type Findings Corrective Actions Audited By
08/02/2025 Labeling 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
04/02/2025 2.0 Updated Labeling Requirements and Documentation Formats Regulatory Compliance QA Head
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