title: Increased importance of the documented development stage in process validation.
abstract: Current trends in pharmaceutical quality assurance moved when the Federal Drug Administration (FDA) of the USA published its new guideline on process validation in 2011. This guidance introduced the lifecycle approach of process validation. In this short communication some typical changes from the point of view of practice of API production are addressed in the light of inspection experiences. Some details are compared with the European regulations.
authors: Quality Assurance Department, Dorog Site, Gedeon Richter Plc., H-2510 Dorog, Esztergomi út 27, Hungary.
authors: Ildikó
authors: I
authors: Mohammed-Ziegler
authors: Ildikó
authors: I
authors: Medgyesi
keywords: Critical parameter; Development; GMP; Lifecycle; Process validation