In GLP, CAPA is used to prevent recurrence through what process?

• A. Training records only.
• B. Root cause analysis to address nonconformances and prevent recurrence.
• C. Disposal of waste.
• D. Budget approval.

Answer: (B)

CAPA in GLP is about a structured approach to prevent problems from recurring by uncovering the true cause of a deviation. When something doesn’t meet GLP standards, the focus is on root cause analysis to understand why it happened, not just fixing the immediate symptom. By identifying the underlying cause, you can implement corrective actions that address that cause and preventive actions that stop the issue from happening again in the future. Verification is then used to show that the actions worked and the process is now stable.

For example, if a data entry error occurs, root cause analysis might reveal gaps in training or unclear SOP steps. A corrective action could be retraining staff and clarifying the procedure, while a preventive action might involve adding automated data verification steps or updating the SOP to prevent future errors. This is the essence of CAPA—correct and prevent, with evidence that the change actually reduces risk.

Other options like disposing of waste or budget approvals don’t target the underlying cause of a GLP nonconformance or its recurrence, and training records alone don’t capture the full corrective-and-preventive process.