Routine, Periodic & Change-Triggered Revalidations in Pharma: What, When & Why Explained Understanding Routine, Periodic, and Change-Driven Revalidations in Pharma Maintaining the validated state of pharmaceutical processes and systems is a regulatory imperative. Revalidation — whether routine, periodic, or change-triggered — ensures continued compliance, product quality, and patient safety throughout the lifecycle of a process or equipment. Revalidation is not just a formality; it is a fundamental requirement under FDA’s Process Validation guidance, EMA Annex 15, and ICH Q9. This guide breaks down the three types of revalidation used in pharma — their purpose, regulatory expectations, how to determine when…