How should deviations be managed in GMP?

• A. Ignore the deviation if production seems normal.
• B. Document the deviation, assess impact, implement corrective actions, and prevent recurrence.
• C. Investigate the deviation, determine root cause, implement corrective actions, and verify effectiveness.
• D. Record the deviation and continue without changes.

Answer: (C)

Managing deviations in GMP requires a disciplined response that moves from facts to action and back to confirmation. Start with a thorough investigation to collect all relevant data and identify the root cause of the deviation. This root-cause understanding is essential because it reveals why the issue occurred and what must be fixed to prevent it from happening again. Next, implement corrective actions to address the immediate problem and, where appropriate, preventive actions to reduce the chance of recurrence in the future. Finally, verify the effectiveness of those actions to ensure the deviation is controlled and the process, equipment, or product are back into a compliant state. All steps should be documented with evidence, and changes to procedures or controls should be made as needed. This approach is necessary because it not only fixes the symptom but also prevents future occurrences, protecting product quality and regulatory compliance. Ignoring deviations, or stopping at mere documentation or impact assessment without root-cause analysis and verification, leaves risk unchecked and does not truly prevent recurrence.