Out-of-Tolerance (OOT) Management & Impact Assessment in Pharma Managing OOT Calibration Events and Impact Assessment in Pharma: A Step-by-Step Guide Introduction Calibration is a cornerstone of Good Manufacturing Practice (GMP). However, even with robust systems, an Out-of-Tolerance (OOT) situation may arise—where the calibration result falls outside the predefined acceptable limits. In the pharma industry, such deviations require swift, structured, and regulatory-compliant responses. This article details a comprehensive guide to OOT handling, root cause analysis, impact assessment, and documentation to remain compliant with global regulators such as the FDA, EMA, and ICH. What is an OOT in Calibration? An Out-of-Tolerance (OOT)…