What is a deviation report in GMP?

• A. A form used to schedule maintenance on equipment.
• B. Documented record of any departure from defined processes, including investigation and corrective action.
• C. A report of supplier performance.
• D. A summary of daily production output.

Answer: (B)

In GMP, a deviation report is a documented record of any departure from defined processes, including the investigation and corrective action. It is used whenever something happens that isn’t in line with established procedures, specifications, or quality attributes, and it guides containment, root-cause analysis, corrective actions, and verification of effectiveness to prevent recurrence. This is the best choice because it specifically captures what went wrong, documents the follow-up steps, and links to actions that restore compliance—unlike maintenance schedules, supplier performance reports, or daily production summaries, which don’t address deviations from the approved processes.