Corrective and Preventive Actions (CAPA) Process

The CAPA process ensures the systematic identification, investigation, and resolution of non-conformities, deviations, and potential risks in compliance with Good Manufacturing Practices (GMP). It follows a structured workflow to implement corrective and preventive actions effectively.

1. CAPA Initiation

When an issue requiring corrective or preventive action is identified, the CAPA process begins.

• A unique CAPA number is assigned.
• The event/source of CAPA is documented (Deviation, Non-Compliance, Trending, Lab Investigation, Other).
• A detailed justification outlines the necessary CAPA actions and acceptance criteria.
• A preliminary completion date is set to estimate when CAPA tasks should be completed.

2. Initial Review & Approval

Before execution, the CAPA must be reviewed and approved.

• Initiator logs the CAPA with a description of the issue.
• Head of Department (HOD) reviews and approves the CAPA request.

3. CAPA Planning & Task Assignment

Once approved, CAPA tasks are structured and assigned.

• QA Task Reviewer evaluates the CAPA tasks to ensure compliance.
• Task Due Dates are defined for proper execution timelines.
• QA Representative assigns the CAPA for execution.

4. CAPA Execution

The responsible persons implement the CAPA actions.

• Responsible persons are assigned specific CAPA tasks.
• Execution follows the defined timelines.
• Tasks are monitored to ensure compliance with corrective or preventive measures.

5. CAPA Closure Readiness

Before final closure, the CAPA is reviewed for completion.

• CAPA Completion Date is recorded.
• A decision is made on whether an Effectiveness Check is required.
• If needed, an Effectiveness Check Task is initiated.

6. Final Approval & CAPA Closure

The CAPA undergoes final quality assurance review before closure.

• QA Representative reviews the CAPA to confirm completion.
• Effectiveness Check (if required) is performed before final approval.
• QA Representative officially closes the CAPA.

Key Benefits of the CAPA Process

• Ensures Regulatory Compliance – Fully aligned with GMP, ISO, and industry standards.
• Systematic Issue Resolution – Prevents recurring deviations and non-conformities.
• Audit-Ready Documentation – Tracks every step for full traceability.
• Integrated Quality Assurance Oversight – Ensures CAPA actions are justified, executed, and reviewed properly.
• Improves Process Efficiency – Reduces risk, enhances operational performance, and prevents future issues.

Conclusion

The CAPA process is a critical component of continuous improvement and compliance management. By ensuring structured approval, task execution, and final verification, it strengthens quality control and prevents recurring issues.

This structured approach provides a transparent, auditable, and efficient workflow for managing corrective and preventive actions in a controlled manner.