SOP for Reporting Deviations in Quarantined Raw Materials – V 2.0

Standard Operating Procedure for Reporting Deviations in Quarantined Raw Materials

Department	Warehouse / Quality Assurance / Regulatory Affairs
SOP No.	SOP/RM/076/2025
Supersedes	SOP/RM/076/2022
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 identifying, documenting, and reporting deviations in quarantined raw materials to ensure corrective actions are taken and compliance with Good Manufacturing Practices (GMP) is maintained.

2. Scope

This SOP applies to all deviations related to raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials stored in the quarantine area prior to Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

Warehouse Personnel: Identify deviations, initiate deviation reports, and segregate affected materials.
Quality Assurance (QA): Review deviation reports, investigate root causes, and approve corrective actions.
Regulatory Affairs: Ensure deviation handling complies with regulatory requirements and is properly documented.

4. Accountability

The Warehouse Manager is responsible for reporting deviations. The QA Manager ensures thorough investigation and appropriate corrective actions, while the Regulatory Affairs Manager ensures compliance with regulatory guidelines.

5. Procedure

5.1 Identification of

Deviations

Deviation Types:
- Physical Damage (e.g., torn packaging, leakage)
- Labeling Errors (e.g., incorrect batch numbers, missing labels)
- Temperature Excursions (e.g., materials stored outside specified temperature ranges)
- Discrepancies in Documentation (e.g., mismatched supplier documents)
- Contamination (e.g., visible contamination, exposure to foreign materials)
Initial Detection:
- Warehouse personnel must immediately report any observed deviations to the Warehouse Manager and QA Manager.
- Segregate affected materials and label them as “Hold.”

5.2 Documentation of Deviations

Deviation Report:
- Complete a Deviation Report (Annexure-1) with the following details:
  - Date and time of deviation
  - Description of the deviation
  - Batch number and material name
  - Initial actions taken
  - Name of the person reporting the deviation
- Submit the report to the QA Manager for further investigation.
Logging Deviations:
- Record all deviations in the Deviation Log (Annexure-2) for tracking and trend analysis.

5.3 Investigation and Root Cause Analysis

QA Investigation:
- The QA team must investigate the deviation within 5 working days of reporting.
- Conduct a root cause analysis to determine the underlying cause of the deviation.
- Document findings in the Root Cause Analysis Form (Annexure-3).
Material Disposition:
- Based on the investigation, QA will determine if the material can be:
  - Released for use
  - Re-tested
  - Rejected and disposed of
- Record the disposition decision in the Deviation Report.

5.4 Corrective and Preventive Actions (CAPA)

Corrective Actions:
- Identify corrective actions to address the immediate deviation.
- Implement actions and document them in the Corrective Action Log (Annexure-4).
Preventive Actions:
- Develop preventive measures to avoid recurrence of similar deviations.
- Document preventive actions in the Preventive Action Log (Annexure-5).

5.5 Reporting and Review

Final Report Submission:
- Prepare a final deviation report summarizing the deviation, investigation, corrective actions, and material disposition.
- Submit the report to the Regulatory Affairs team for review and archival.
Trend Analysis:
- QA must review deviation trends quarterly to identify recurring issues and implement systemic improvements.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions

7. Documents

Deviation Report (Annexure-1)
Deviation Log (Annexure-2)
Root Cause Analysis Form (Annexure-3)
Corrective Action Log (Annexure-4)
Preventive Action 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: Deviation Report

Date	Material Name	Batch Number	Description of Deviation	Reported By	Initial Action Taken
01/02/2025	API-X	X-2025-001	Temperature Excursion (2°C above limit)	Ravi Kumar	Material moved to “Hold”

Annexure-2: Deviation Log

Date	Material Name	Batch Number	Deviation Type	Status	QA Review
01/02/2025	API-X	X-2025-001	Temperature Excursion	Under Investigation	Anjali Mehta

Annexure-3: Root Cause Analysis Form

Date	Material Name	Batch Number	Root Cause Identified	Investigated By
02/02/2025	API-X	X-2025-001	Faulty HVAC Sensor	Ajay Singh

Annexure-4: Corrective Action Log

Date	Deviation Description	Corrective Action	Implemented By	QA Verification
03/02/2025	Temperature Excursion	Replaced HVAC Sensor	Sunita Sharma	Verified by Anjali Mehta

Annexure-5: Preventive Action Log

Date	Deviation Description	Preventive Action	Implemented By	Follow-Up Required
04/02/2025	Temperature Excursion	Monthly HVAC System Checks	Ajay Singh	Yes

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	Updated Deviation Reporting Procedures	Regulatory Compliance	QA Head