Process Qualification Protocols: Equipment, Utilities & Process Systems Creating Process Qualification Protocols for Equipment, Utilities & Systems in Pharma Stage 2 of pharmaceutical process validation—Process Qualification (PQ)—is the critical phase where designed processes, equipment, and systems are tested under actual operating conditions to confirm performance, reproducibility, and compliance. This article offers QA, QC, Validation, and Regulatory teams a complete tutorial on designing and executing qualification protocols for equipment, utilities, and process systems in compliance with FDA, EMA Annex 15, and ICH Q9 guidelines. What Is Process Qualification in Stage 2? According to the FDA’s 2011 Process Validation Guidance, Stage 2…