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.

5. Procedure

5.1 Identification and Reporting of Storage Issues

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).
Initial Documentation:
- Log the identified issue in the Storage Issue Log (Annexure-2).

5.2 Investigation and Root Cause Analysis

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).
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

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).
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

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).
Monitoring Effectiveness:
- Monitor the effectiveness of preventive actions through regular audits and inspections.
- Record monitoring results in the Preventive Action Monitoring Log (Annexure-8).

5.5 Training and Continuous Improvement

Training on CAPA Procedures:
- Conduct training sessions for warehouse personnel on CAPA procedures.
- Document training in the CAPA Training Log (Annexure-9).
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

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

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