Lifecycle Approach to Process Validation: ICH and FDA Guidance Lifecycle Approach to Process Validation: ICH and FDA Guidance Understanding the Validation Lifecycle The validation lifecycle in pharmaceutical manufacturing is a rigorous process designed to ensure that systems, processes, and products consistently meet predetermined specifications and quality attributes. This lifecycle is divided into several critical phases: Process Design, Qualification (including Installation Qualification, Operational Qualification, and Performance Qualification), Post-Process Verification, Continued Process Verification (CPV), and Revalidation. By adhering to the guidance set forth by the FDA, EMA and ICH guidelines, organizations can ensure compliance and maintain product quality. Step 1: User Requirements…