What does CAPA stand for and how is it used in GLP?

• A. Corrective Action and Preventive Action; used to address nonconformances.
• B. Compliance and Preventive Audit.
• C. Control and Assessment.
• D. Corrective and Preventive Action; used to schedule maintenance.

Answer: (B)

CAPA in GLP means Corrective Action and Preventive Action. It’s a structured process for handling quality issues: when a nonconformance or deviation occurs, you investigate to find the root cause, implement corrective actions to fix the immediate problem and prevent it from happening again, and put preventive actions in place to reduce the risk of similar issues in the future. Verification and documentation are essential, so you can show regulators that the actions were effective and the system remains compliant. This approach helps maintain data integrity and overall quality in GLP studies. The other phrases describe different concepts or uses that don’t capture CAPA’s purpose, which is to both correct current issues and prevent future ones.