CAPA System - In a nutshell

Definition:

CAPA stands for Corrective and Preventive Action. It is a systematic approach used in the pharmaceutical industry to identify, investigate, and eliminate the root causes of problems or potential issues in processes, systems, or products.

Identification:

CAPA is initiated when a deviation, complaint, audit observation, OOS (Out of Specification), or equipment failure occurs. The first step is to record and categorize the issue accurately.

Root Cause Analysis (RCA):

Techniques like 5 Whys, Fishbone Diagram, or Pareto Analysis are used to find the actual cause of the problem instead of just addressing symptoms.

Corrective Action:

Steps taken to eliminate the root cause of an existing issue, ensuring it does not happen again.

Preventive Action:

Actions implemented to prevent potential issues from occurring in the future, based on trend analysis or risk assessment.

Implementation:

CAPA plans are created with responsibility, timeline, verification, and effectiveness checks. Actions are tracked until completion.

Documentation:

Every CAPA must be documented properly in the CAPA log or software system with evidence, approvals, and effectiveness checks.

Review and Approval:

Quality Assurance (QA) reviews all CAPA actions for adequacy and closes them after verifying effectiveness.

Closing of CAPA:

CAPA can be closed only after evidence-based verification that the problem has been resolved and no recurrence is observed.

Importance:

Ensures product quality and compliance.

Promotes continuous improvement.

Reduces recurrence of deviations.

Builds regulatory confidence and improves audit readiness.