Deviations in Pharmaceutical industry l Interview Questions

This video provides a comprehensive overview of deviations within the pharmaceutical industry, framed as a series of interview questions and answers. It covers the fundamental definition, classification, and regulatory importance of deviations, alongside detailed discussions on their investigation, impact assessment, and management within a Quality Management System (QMS). The speaker emphasizes the structured approach required for handling deviations, from initial identification and reporting to root cause analysis, corrective and preventive actions (CAPA), and closure, highlighting the critical role deviations play in ensuring product quality and regulatory compliance.

Key Takeaways:

• Foundational Role in QMS & Compliance: Deviations are defined as departures from established procedures and are a core component of pharmaceutical QMS, directly impacting regulatory compliance (e.g., ICH Q10, GxP). Proper handling is a regulatory expectation.
• Structured Investigation & Impact Assessment: The process involves classifying deviations (minor, major, critical), forming cross-functional teams (CFTs) for investigation, utilizing various tools (e.g., 5 Why, Fishbone, FMEA), and performing comprehensive impact assessments on existing, previous, and future batches.
• Timeliness and Root Cause Focus: Prompt reporting (within 24 hours) and adherence to defined closure timelines are crucial for effective deviation management. The primary goal is to identify the root cause (or most probable cause) to prevent recurrence, with human error being a frequently cited factor.
• QMS Software Integration: The video explicitly mentions specialized software like TrackWise as commonly used for deviation handling, indicating the industry's reliance on dedicated systems for managing these critical processes. This highlights an opportunity for AI-powered enhancements or custom integrations.
• Procedural Rigor and Data Integrity: The discussion underscores the need for clear procedures for various scenarios, such as distinguishing deviations from incidents, avoiding "planned deviations" in favor of change controls, and the importance of not covering multiple discrepancies in a single deviation. The deviation count serves as an indicator of the overall health and control of a facility's QMS.