SOP Guide for Pharma

SOP for Corrective and Preventive Action (CAPA) in Storage Issues – V 2.0

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SOP for Corrective and Preventive Action (CAPA) in Storage Issues – V 2.0

Standard Operating Procedure for Corrective and Preventive Action (CAPA) in Storage Issues

Department Warehouse / Quality Assurance
SOP No. SOP/RM/178/2025
Supersedes SOP/RM/178/2022
Page No. Page 1 of 15
Issue Date 13/04/2025
Effective Date 20/04/2025
Review Date 13/04/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the Corrective and Preventive Action (CAPA) process for addressing and mitigating storage-related issues in the warehouse. The objective is to identify the root cause of non-conformities and implement measures to prevent recurrence, ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Warehouse and Quality Assurance (QA) departments involved in identifying, documenting, investigating, and resolving storage-related issues within the facility.

3. Responsibilities

  • Warehouse Personnel: Identify and report storage issues promptly and assist in implementing corrective actions.
  • Quality Assurance (QA) Team: Investigate storage issues, perform root cause analysis, and oversee the implementation of corrective and preventive actions.
  • Warehouse Manager: Ensure corrective actions are applied effectively and prevent recurrence of storage issues.

4. Accountability

The QA Manager is accountable for the overall CAPA process, including monitoring the effectiveness of corrective and preventive actions. The Warehouse Manager is responsible for

implementing the actions and ensuring compliance with storage standards.
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5. Procedure

5.1 Identification and Reporting of Storage Issues

  1. Issue Detection:
    • Identify storage issues such as temperature deviations, humidity fluctuations, improper labeling, and material damage.
    • Report issues immediately using the Storage Issue Reporting Form (Annexure-1).
  2. Initial Documentation:
    • Log the identified issue in the Storage Issue Log (Annexure-2).

5.2 Investigation and Root Cause Analysis

  1. Issue Investigation:
    • The QA team will investigate the issue by reviewing storage conditions, equipment status, and personnel activities.
    • Document investigation findings in the Issue Investigation Report (Annexure-3).
  2. Root Cause Analysis:
    • Conduct a root cause analysis using tools such as the 5 Whys or Fishbone Diagram.
    • Record root cause analysis results in the Root Cause Analysis Log (Annexure-4).

5.3 Implementation of Corrective Actions

  1. Action Planning:
    • Develop corrective actions based on root cause analysis to address the immediate issue.
    • Document the corrective action plan in the Corrective Action Plan Log (Annexure-5).
  2. Action Execution:
    • Implement corrective actions and monitor their effectiveness.
    • Record the execution of actions in the Corrective Action Execution Log (Annexure-6).

5.4 Preventive Measures and Monitoring

  1. Preventive Action Planning:
    • Identify and implement preventive measures to avoid recurrence of storage issues.
    • Document preventive actions in the Preventive Action Plan Log (Annexure-7).
  2. Monitoring Effectiveness:
    • Monitor the effectiveness of preventive actions through regular audits and inspections.
    • Record monitoring results in the Preventive Action Monitoring Log (Annexure-8).
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5.5 Training and Continuous Improvement

  1. Training on CAPA Procedures:
    • Conduct training sessions for warehouse personnel on CAPA procedures.
    • Document training in the CAPA Training Log (Annexure-9).
  2. Review and Update of CAPA Procedures:
    • Review CAPA effectiveness quarterly and update procedures as needed to reflect best practices and regulatory requirements.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Storage Issue Reporting Form (Annexure-1)
  2. Storage Issue Log (Annexure-2)
  3. Issue Investigation Report (Annexure-3)
  4. Root Cause Analysis Log (Annexure-4)
  5. Corrective Action Plan Log (Annexure-5)
  6. Corrective Action Execution Log (Annexure-6)
  7. Preventive Action Plan Log (Annexure-7)
  8. Preventive Action Monitoring Log (Annexure-8)
  9. CAPA Training Log (Annexure-9)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • WHO Guidelines on Good Storage Practices
  • FDA Guidance on CAPA Procedures

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

Annexure-1: Storage Issue Reporting Form

Date Issue Description Reported By Storage Area
13/04/2025 Temperature deviation detected Ravi Kumar Cold Storage

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Annexure-2: Storage Issue Log

Date Issue Description Status Logged By
13/04/2025 Humidity exceeded limits Open Neha Verma

Annexure-3: Issue Investigation Report

Date Issue Investigated Findings Investigated By
13/04/2025 Temperature deviation Faulty thermostat detected Amit Joshi

Annexure-4: Root Cause Analysis Log

Date Issue Description Root Cause Identified Analyzed By
13/04/2025 Humidity fluctuation Inadequate dehumidifier maintenance Priya Singh

Annexure-5: Corrective Action Plan Log

Date Issue Description Corrective Action Planned By
13/04/2025 Faulty thermostat Replace thermostat Kiran Patel

Annexure-6: Corrective Action Execution Log

Date Corrective Action Status Executed By
13/04/2025 Replace thermostat Completed Ajay Sharma

Annexure-7: Preventive Action Plan Log

Date Preventive Measure Status Planned By
13/04/2025 Monthly thermostat calibration Scheduled QA Supervisor

Annexure-8: Preventive Action Monitoring Log

Date Preventive Action Effectiveness Monitored By
13/04/2025 Thermostat calibration Effective QA Manager

Annexure-9: CAPA Training Log

Date Employee Name Training Topic Trainer Remarks
13/04/2025 Sanjay Mehta CAPA Procedures QA Manager Completed Successfully

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
13/04/2025 2.0 Updated CAPA process and documentation requirements. Regulatory Update QA Head
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