Identifying What Changes Demand Revalidation How to Identify Which Changes Require Revalidation in Pharma In pharmaceutical manufacturing, maintaining a validated state is a fundamental requirement of GMP. As systems, processes, and equipment evolve, the question arises: which changes demand revalidation? Not all changes carry the same risk — but failing to revalidate when required can lead to major compliance issues, product quality failures, and regulatory action. This guide provides a comprehensive framework to identify changes that necessitate revalidation, based on regulatory guidelines, risk-based thinking, and best practices for integrating with change control systems. 1. Regulatory Context for Revalidation Triggers Global…