What is the role of CAPA in GLP deviation management?

• A. CAPA is optional for deviation management
• B. CAPA stands for Corrective and Preventive Actions; deviations should be addressed through CAPA processes
• C. CAPA is used only during audits and not for deviations
• D. CAPA is the formal process to manage deviations, ensuring root-cause analysis and preventive actions

Answer: (D)

CAPA in GLP deviation management is the formal mechanism for handling any deviation by investigating its root cause and implementing actions that both fix the current issue and prevent it from happening again. In GLP, deviations aren’t just about correcting what went wrong; they’re about understanding why it happened, applying corrective actions to restore compliance, and putting preventive actions in place to stop recurrence in future studies or processes. The CAPA process involves documenting the deviation, conducting root-cause analysis, selecting and implementing corrective and preventive actions, assigning responsibilities, verifying effectiveness, and closing out with thorough records. This approach supports regulatory compliance and continual quality improvement, and it’s applied whenever deviations occur, not only during audits.