SOP Guide for Pharma

SOP for Handling Raw Materials Arriving in Damaged Packaging – V 2.0

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SOP for Handling Raw Materials Arriving in Damaged Packaging – V 2.0

Standard Operating Procedure for Handling Raw Materials Arriving in Damaged Packaging

Department Warehouse / Quality Assurance / Quality Control / Procurement
SOP No. SOP/RM/053/2025
Supersedes SOP/RM/053/2022
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 steps for handling raw materials that arrive at the facility with damaged packaging. It ensures proper identification, documentation, segregation, and assessment to prevent contamination, maintain material integrity, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw materials received at the facility, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, that arrive with any form of visible packaging damage. It covers inspection, documentation, quarantine, and corrective actions.

3. Responsibilities

  • Warehouse Personnel: Inspect raw materials for damage upon arrival, document findings, and segregate damaged materials.
  • Quality Assurance (QA): Review damage reports, determine material disposition, and ensure compliance with GMP standards.
  • Quality Control (QC): Conduct additional testing if required to assess material integrity.
  • Procurement Department: Coordinate with suppliers to resolve issues related to damaged materials.

4. Accountability

The Warehouse Manager is responsible for ensuring the

proper inspection and segregation of materials with damaged packaging. The QA Manager holds authority for final disposition decisions, while the Procurement Manager ensures timely resolution with suppliers. The QC Manager evaluates any potential quality impact.
See also  SOP for Conducting Initial Inspection of Water-Sensitive Raw Materials - V 2.0

5. Procedure

5.1 Inspection at Receiving

  1. Visual Inspection:
    • Upon delivery, Warehouse personnel inspect all raw material packages for signs of damage, such as:
      • Tears, punctures, or holes in the packaging.
      • Broken seals or tampering evidence.
      • Water damage, stains, or moisture exposure.
    • Document findings in the Packaging Damage Log (Annexure-1).
  2. Initial Assessment:
    • If damage is detected, the material must be immediately segregated from undamaged goods and labeled as “DAMAGED – UNDER REVIEW.”
    • Notify QA and Procurement for further evaluation.

5.2 Documentation and Reporting

  1. Damage Report:
    • Complete the Packaging Damage Report (Annexure-2), including:
      • Type and extent of damage.
      • Photos of the damaged packaging (if applicable).
      • Batch number and supplier details.
  2. Notification:
    • Warehouse sends the Packaging Damage Report to QA and Procurement for review.

5.3 QA Assessment and Material Disposition

  1. Material Integrity Evaluation:
    • QA assesses whether the packaging damage has potentially compromised the raw material.
    • QA may request QC to perform additional testing to confirm material integrity.
  2. Disposition Decision:
    • Materials are categorized as:
      • Approved: If the material is unaffected by the packaging damage and passes all quality checks.
      • Rework/Relabel: If the material is suitable for use after re-packaging or re-labeling.
      • Rejected: If the material integrity is compromised.
    • Document the decision in the Material Disposition Log (Annexure-3).
See also  SOP for Inspection of Double-Checked and Double-Bagged Raw Materials - V 2.0

5.4 Supplier Coordination

  1. Supplier Notification:
    • Procurement contacts the supplier with the Packaging Damage Report and photos.
    • Request corrective actions, such as material replacement or packaging improvements.
  2. Corrective Actions Documentation:
    • Document the supplier’s corrective actions in the Corrective Action Log (Annexure-4).

5.5 Handling of Rejected Materials

  1. Segregation and Labeling:
    • Rejected materials are clearly labeled and moved to the rejection area.
  2. Disposal or Return:
    • Rejected materials may be returned to the supplier or disposed of according to the Disposal SOP.
    • Document all actions in the Rejected Material Log (Annexure-5).

6. Abbreviations

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

7. Documents

  1. Packaging Damage Log (Annexure-1)
  2. Packaging Damage Report (Annexure-2)
  3. Material Disposition Log (Annexure-3)
  4. Corrective Action Log (Annexure-4)
  5. Rejected Material 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
  • EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

See also  SOP for Assigning Goods Receipt Note (GRN) Number to Received Materials - V 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Packaging Damage Log

Date Material Name Batch Number Type of Damage Reported By Remarks
01/02/2025 API-X X-2025-001 Punctured Packaging John Doe Segregated for QA Review
02/02/2025 Excipient-Y Y-2025-002 Broken Seal Jane Smith Quarantined for Further Testing

Annexure-2: Packaging Damage Report

Date Material Name Batch Number Type of Damage Photos Attached Reported By
01/02/2025 API-X X-2025-001 Punctured Packaging Yes John Doe

Annexure-3: Material Disposition Log

Date Material Name Batch Number Disposition Approved By Remarks
03/02/2025 API-X X-2025-001 Rejected QA Manager Puncture May Have Compromised Material Integrity

Annexure-4: Corrective Action Log

Date Supplier Name Material Name Batch Number Corrective Action Taken Follow-Up Required
03/02/2025 PharmaSuppliers Ltd. API-X X-2025-001 Material Replaced, Packaging Reinforced Yes

Annexure-5: Rejected Material Log

Date Material Name Batch Number Reason for Rejection Disposition Method Handled By
04/02/2025 API-X X-2025-001 Punctured Packaging Returned to Supplier John Doe

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 Added Corrective Action and Rejected Material Handling Procedures Standardization QA Head
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