SOP for Implementing Corrective and Preventive Actions (CAPA)

Standard Operating Procedure for Implementing Corrective and Preventive Actions (CAPA)

1) Purpose

This SOP outlines the procedures for identifying, implementing, and monitoring corrective and preventive actions (CAPA) to ensure the continuous improvement of GMP processes and compliance.

2) Scope

This SOP applies to all personnel responsible for identifying deviations, non-conformances, and other issues requiring CAPA at [Company Name].

3) Responsibilities

Department Supervisors: Identify issues requiring CAPA and ensure that corrective actions are implemented.
Quality Assurance (QA): Monitors the effectiveness of CAPA and ensures compliance with GMP standards.

4) Procedure

4.1 Identifying Issues Requiring CAPA

4.1.1 Sources of CAPA

CAPA may be required as a result of internal audits, deviations, non-conformances, complaints, or process failures. Any identified issues should be documented in the CAPA log.

4.1.2 CAPA Investigation

Perform a root cause analysis for each identified issue to determine the underlying cause. Use tools such as Fishbone Diagrams, 5-Why Analysis, or Failure Mode and Effect Analysis (FMEA).

4.2 Implementing Corrective Actions

4.2.1 Developing Corrective Actions

Based on the root cause analysis, develop corrective actions to address the issue. Corrective actions should be specific, measurable, achievable,

relevant, and time-bound (SMART).

Document the proposed corrective actions in the CAPA log and submit them for QA approval.

4.2.2 Implementing Corrective Actions

Department supervisors must implement corrective actions according to the proposed timeline. Document the completion of corrective actions in the CAPA log and submit for QA review.

4.3 Implementing Preventive Actions

4.3.1 Identifying Preventive Measures

Review processes to identify potential risks or failures that could lead to non-conformance. Implement preventive measures to mitigate these risks before issues occur.

4.3.2 Monitoring Preventive Actions

Document all preventive actions in the CAPA log and monitor their effectiveness over time. Ensure that preventive measures are integrated into relevant SOPs and processes.

4.4 Post-CAPA Activities

4.4.1 Monitoring CAPA Effectiveness

QA will conduct follow-up audits to verify the effectiveness of corrective and preventive actions. Document the results of follow-up audits in the CAPA log.

4.4.2 Documentation

All CAPA-related activities, including root cause analysis, corrective actions, preventive actions, and follow-up audits, must be documented in the CAPA log and retained for regulatory audits.

5) Abbreviations, if any

CAPA: Corrective and Preventive Action
QA: Quality Assurance

6) Documents, if any

CAPA Log

7) References, if any

Internal SOP for root cause analysis

8) SOP Version

Version 1.0

Annexure

1. CAPA Log Template


  
    Date
    Issue Identified
    Root Cause
    Corrective Action
    Preventive Action
    Due Date
    QA Approval
  
  
    DD/MM/YYYY
    Description of Issue
    Root Cause Analysis
    Corrective Action Taken
    Preventive Action Implemented
    Deadline for Completion
    QA Name

Date	Issue Identified	Root Cause	Corrective Action	Preventive Action	Due Date	QA Approval
DD/MM/YYYY	Description of Issue	Root Cause Analysis	Corrective Action Taken	Preventive Action Implemented	Deadline for Completion	QA Name