Standard Operating Procedure for Corrective and Preventive Actions

1) Purpose

The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and implementing corrective and preventive actions (CAPAs) to address deviations, non-conformances, and potential issues within the pharmaceutical manufacturing processes.

2) Scope

This SOP applies to all personnel responsible for initiating, managing, and closing CAPAs within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Quality Assurance (QA) Team

• Oversee CAPA process and ensure compliance with SOP.
• Approve CAPA plans and verify effectiveness of actions.

3.2 Manufacturing and Quality Control (QC) Teams

• Initiate CAPA requests and provide necessary documentation.
• Implement CAPA actions within specified timelines.

4) Procedure

4.1 CAPA Initiation

1. Identify deviation or non-conformance requiring CAPA.
2. Document CAPA request with details of issue, root cause analysis, and proposed actions.

4.2 CAPA Investigation

1. Conduct thorough investigation to determine root cause(s) of the issue.
2. Perform risk assessment to evaluate impact and severity.

4.3 CAPA Plan Development

1. Develop CAPA plan outlining corrective and preventive actions.
2. Assign responsibilities and establish timelines for implementation.

4.4 CAPA Implementation

1. Implement identified corrective actions to address immediate issues.
2. Implement preventive actions to prevent recurrence of the issue.

4.5 CAPA Effectiveness Review

1. Monitor and verify effectiveness of implemented CAPA actions.
2. Close CAPA after confirming resolution and preventive measures.

5) Abbreviations, if any

SOP: Standard Operating Procedure; CAPA: Corrective and Preventive Actions; QA: Quality Assurance; QC: Quality Control

6) Documents, if any

• CAPA Request Form
• Root Cause Analysis Report
• CAPA Plan and Implementation Records

7) Reference, if any

ICH Q10: Pharmaceutical Quality System
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

8) SOP Version

Version 1.0