SOP Guide for Pharma

SOP for Handling and Documenting Storage Deviations and Non-Conformances – V 2.0

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SOP for Handling and Documenting Storage Deviations and Non-Conformances – V 2.0

Standard Operating Procedure for Handling and Documenting Storage Deviations and Non-Conformances

Department Quality Assurance / Warehouse
SOP No. SOP/RM/167/2025
Supersedes SOP/RM/167/2022
Page No. Page 1 of 14
Issue Date 03/04/2025
Effective Date 10/04/2025
Review Date 03/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for identifying, handling, and documenting storage deviations and non-conformances in raw material warehouses. It ensures systematic management of any deviation from standard storage conditions, maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all storage areas, including ambient, refrigerated, and controlled environments, where raw materials are stored. It covers the identification, documentation, investigation, and resolution of storage deviations and non-conformances.

3. Responsibilities

4. Accountability

The QA Manager is accountable for ensuring all storage deviations are documented and resolved appropriately. The Warehouse Manager is responsible for the timely reporting and management of deviations.

5. Procedure

5.1 Identification and Reporting of Deviations

  1. Definition of Deviation:
    • A deviation is any departure from the established storage conditions, procedures, or standards. Examples include temperature excursions, humidity fluctuations, improper labeling, or unauthorized access to storage areas.
  2. Reporting Process:
    • Warehouse personnel must immediately report observed deviations to the Warehouse Supervisor using the Deviation Reporting Form (Annexure-1).
    • The Warehouse Supervisor must notify the QA department within 2 hours of identifying the deviation.
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5.2 Initial Assessment and Immediate Actions

  1. Immediate Control Measures:
    • Take immediate actions to control or mitigate the impact of the deviation, such as relocating affected materials to compliant storage or adjusting environmental controls.
    • Document immediate actions taken in the Deviation Immediate Action Log (Annexure-2).
  2. Initial Assessment:
    • The Warehouse Supervisor, in consultation with QA, will perform an initial assessment to determine the potential impact on material quality.
    • If materials are suspected to be compromised, quarantine them until further investigation is complete.

5.3 Investigation and Root Cause Analysis

  1. Investigation Process:
    • The QA department will initiate a detailed investigation to determine the root cause of the deviation within 24 hours of reporting.
    • Use tools such as the 5 Whys or Fishbone Diagram to identify root causes.
    • Document the investigation in the Deviation Investigation Report (Annexure-3).
  2. Classification of Deviations:
    • Classify deviations as minor, major, or critical based on their potential impact on product quality and patient safety.
    • Record the classification in the Deviation Classification Log (Annexure-4).

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5.4 Corrective and Preventive Actions (CAPA)

  1. Corrective Actions:
    • Implement corrective actions to address the immediate cause of the deviation and prevent recurrence.
    • Document corrective actions in the Corrective Action Log (Annexure-5).
  2. Preventive Actions:
    • Develop preventive measures to eliminate systemic issues contributing to deviations, such as process changes or additional training.
    • Document preventive actions in the Preventive Action Log (Annexure-6).

5.5 Deviation Closure and Documentation

  1. Final Review and Approval:
    • The QA department will review all documentation and verify the effectiveness of corrective and preventive actions before closing the deviation.
    • Document the closure in the Deviation Closure Log (Annexure-7).
  2. Archiving Records:
    • All deviation records must be securely stored and accessible for regulatory inspections and internal audits.

6. Abbreviations

7. Documents

  1. Deviation Reporting Form (Annexure-1)
  2. Deviation Immediate Action Log (Annexure-2)
  3. Deviation Investigation Report (Annexure-3)
  4. Deviation Classification Log (Annexure-4)
  5. Corrective Action Log (Annexure-5)
  6. Preventive Action Log (Annexure-6)
  7. Deviation Closure Log (Annexure-7)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department
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Annexure-1: Deviation Reporting Form

Date Deviation Description Reported By Storage Area
03/04/2025 Temperature excursion in cold storage Ravi Kumar Cold Storage Unit

Annexure-2: Deviation Immediate Action Log

Date Action Taken Performed By Remarks
03/04/2025 Adjusted thermostat and relocated materials Neha Verma Materials moved to compliant storage

Annexure-3: Deviation Investigation Report

Date Investigation Findings Root Cause Investigated By
04/04/2025 Thermostat malfunction due to electrical issue Faulty wiring in cooling unit Amit Joshi

Annexure-4: Deviation Classification Log

Date Deviation Description Severity Classified By
04/04/2025 Temperature excursion in cold storage Major QA Manager

Annexure-5: Corrective Action Log

Date Corrective Action Performed By Verified By
05/04/2025 Replaced faulty thermostat and repaired wiring Maintenance Team QA Team

Annexure-6: Preventive Action Log

Date Preventive Action Reason Implemented By
06/04/2025 Installed backup temperature monitoring system Prevent future excursions Ravi Kumar

Annexure-7: Deviation Closure Log

Date Deviation Description Closure Status Approved By
07/04/2025 Temperature excursion in cold storage Closed QA Manager

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP Implementation QA Head
03/04/2025 2.0 Added CAPA Documentation Requirements Regulatory Compliance Update QA Head
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