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.

5. Procedure

5.1 Inspection at Receiving

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).
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

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.
Notification:
- Warehouse sends the Packaging Damage Report to QA and Procurement for review.

5.3 QA Assessment and Material Disposition

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.
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).

5.4 Supplier Coordination

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

5.5 Handling of Rejected Materials

Segregation and Labeling:
- Rejected materials are clearly labeled and moved to the rejection area.
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

Packaging Damage Log (Annexure-1)
Packaging Damage Report (Annexure-2)
Material Disposition Log (Annexure-3)
Corrective Action Log (Annexure-4)
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

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