Privatsphäre-Einstellungen

Grundlagen der FDA-Anforderungen an die Anlagenqualifizierung und Prozessvalidierung

Dr. Jörg Fetsch

Haema AG, Berlin

General Principles of the FDA Requirements for Equipment Qualification and Process Validation

Until recently, the FDA had published two guidelines on equipment qualification and process validation. That was the “Guideline on General Principles of Process Validation”, that was published in 1987. Furthermore, it was the Guidance for Industry “Process Validation: General Principles and Practices”, published in 2008 as a draft version. This draft has just been finalized on January 24, 2011 and is valid now. This article presents both guidelines and describes the different procedures for qualification/validation. Finally, there is an assessment of both guidelines also with respect to the annex 15 of the EU GMP Guide.