Standard Operating Procedure for the Handling of Deviation and Incident

Description

Pharmaceutical manufacturing requires strict adherence to quality standards to ensure product safety and efficacy. Deviations, any unplanned event that differs from established procedures, and incidents, more serious events with potential product impact, must be promptly addressed.

Deviation management involves timely identification, investigation to determine root cause, and implementation of corrective and preventive actions (CAPA) to prevent recurrence. Incidents necessitate thorough investigation, potential product recall or quarantine, and regulatory notification.

Effective deviation and incident management fosters a culture of continuous improvement, minimizes risks, and protects patient safety.