Trending Deviations and Out-of-Trend (OOT) Events Trending Deviations and Out-of-Trend Events in CPV: Detection, Investigation & Regulatory Compliance In the context of Continued Process Verification (CPV), managing variability is not limited to individual out-of-specification (OOS) results. Trending deviations and Out-of-Trend (OOT) events provide early warnings of potential process drift, long before failure occurs. Identifying, evaluating, and reacting to these trends are essential for maintaining control and ensuring regulatory compliance. This article explores how pharma manufacturers should handle OOTs, trending deviations, and signal detection under a robust CPV framework, including documentation, investigation strategies, and corrective action plans (CAPA). 1. Defining Out-of-Trend…