FDA/EMA Expectations on Change Control & Revalidation: Ensuring Compliance Across the Lifecycle What FDA and EMA Expect from Pharma on Change Control and Revalidation Activities In the pharmaceutical industry, compliance doesn’t end after initial validation. The FDA and EMA both emphasize the importance of ongoing control throughout the product lifecycle, especially when changes are made to validated systems, processes, or equipment. At the heart of this continuous oversight lie two interlinked pillars of pharmaceutical quality systems: Change Control and Revalidation. This article presents a detailed overview of how global regulators expect pharmaceutical companies to manage change and revalidation activities in…