How should deviations be approved and recorded in GLP workflows?

• A. By casual supervisor notification only
• B. Through formal approval, documentation, and alignment with CAPA and QA processes; timely reporting is essential
• C. By automatic system flags with no human review
• D. After study completion to avoid delays

Answer: (B)

In GLP workflows, deviations must be handled through a formal, documented process that integrates with CAPA and quality assurance. When a deviation occurs, it should be promptly evaluated and approved by the appropriate authority, and all details—the cause, impact on the study and data, and actions taken—must be recorded in a deviation log. This creates a traceable record of why the deviation happened and what was done about it.

Formal approval ensures accountability and regulatory compliance, while documentation provides a clear audit trail. Aligning with CAPA means not only addressing the immediate deviation but also identifying root causes and implementing corrective or preventive actions to reduce the chance of recurrence. QA oversight ensures the deviation handling follows SOPs and GLP requirements, safeguarding data integrity and study validity. Timely reporting is essential so that any data affected can be identified, reviewed, and, if needed, reanalyzed or flagged for interpretation.

Casual notification lacks the necessary formal approval and QA involvement, so it doesn’t provide the required traceability. Automatic system flags without human review miss critical judgment about impact and adequacy of actions. Waiting until the end of the study delays detection and could compromise data integrity and regulatory compliance.