FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice. FDA issued the guidance document Process Validation: General Principles ...

“High stakes tests” encompass any tests used to make significant decisions about a person’s care and are intimately tied to an individual’s medical treatment, social perception by others, and often ...

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality ...