What steps should be taken when a deviation from GLP procedures is identified?

• A. Deviation is ignored if it seems minor
• B. Deviation is documented and reported to QA only after study completion
• C. Deviation is documented, formally approved, and aligned with CAPA and QA processes; timely reporting is essential
• D. Deviation requires no action if data appears acceptable

Answer: (C)

When a deviation from GLP procedures is identified, the essential approach is to handle it through documented, formal processes that involve CAPA and QA, with timely reporting. Documenting the deviation creates a clear record of what happened, who observed it, when it occurred, and the potential impact on study integrity. Formal approval ensures someone with responsibility assesses the deviation’s risk to the study and decides whether it affects data validity or requires actions. Aligning with CAPA means launching an investigation to determine root cause and implementing corrective and preventive actions to prevent recurrence. QA involvement provides independent oversight, ensuring the deviation is managed in line with GLP requirements and that the study remains auditable. Reporting promptly is crucial so decisions about data interpretation, data qualification, or necessary remediation can be made without delay, preserving data integrity and regulatory compliance. Ignoring deviations or delaying reporting undermines GLP goals and can compromise study reliability.