Process Validation in Pharma: FDA Lifecycle, PPQ, Continued Process Verification & Health Canada GUI-0029
Published by: Pharma Quality System Editorial Team • Editorial basis: FDA Process Validation guidance, 21 CFR Parts 210/211, Health Canada GUI-0029 and GUI-0001 PROCESS DESIGN • PPQ • CONTINUED PROCESS VERIFICATION Process validation is a lifecycle system for building scientific evidence that a pharmaceutical manufacturing process can consistently deliver product meeting predefined quality requirements-from process design and commercial-scale qualification through ongoing monitoring of routine production. Quick answer FDA organizes process validation into Stage 1: Process Design , Stage 2: Process Qualification , and Stage 3: Continued Process Verification . Health Canada GUI-0029 uses a closely aligned lifecycle: Phase 1: Process Design , Phase 2: Process Performance Qualification (PPQ) , and Phase 3: Ongoing Process Verification . Important terminology: Continued Process Verification is FDA's Stage 3 routine monitoring after PPQ. Continuous Process Verif...