How should a GLP facility respond to a nonconformance finding?

• A. Initiate an investigation, document root cause, implement corrective action, and verify effectiveness; report to QA.
• B. Shut down the facility immediately.
• C. Only document the issue without action.
• D. Ignore until the next audit.

Answer: (A)

When a GLP nonconformance is found, it should trigger a formal CAPA process: start with an investigation to determine what happened and why, document the root cause, implement corrective actions to prevent recurrence, verify that those actions actually fix the issue, and report the finding and resolution to Quality Assurance to ensure proper documentation and oversight. This sequence moves beyond mere record-keeping and ensures the problem is resolved and traceable, which is essential for GLP compliance. Merely documenting the issue leaves the problem unaddressed; shutting down the facility is excessive unless safety is at risk; and ignoring it until the next audit lets the issue recur and undermines data integrity and regulatory confidence.