Process validation is the documented evidence that a manufacturing process, operated within defined parameters, consistently produces a drug substance or drug product meeting its predetermined specifications and critical quality attributes (CQAs). In accordance with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines, process validation encompasses three stages: process design (defining the process based on process development and characterization data), process qualification (confirming that the process performs as intended at commercial scale), and continued process verification (ongoing monitoring of process consistency during routine manufacturing). It is a mandatory requirement for GMP compliance and regulatory approval of biologics, gene and cell therapies, and viral vector.
