FDA-Inspektionen in der Arzneimittel- und Wirkstoffproduktion
Dr. Reiner Kirrstetter
Aventis Pharma Deutschland GmbH, Global Quality Operations, Frankfurt/Main
FDA Inspections of Drug Products and Active Pharmaceutical Ingredients
In the following article the main topics of FDA inspections based on the new system oriented approach are described in detail. The GMP deficiencies that FDA expects in each system are presented with examples.
As the inspection management of a company has an essential influence on the results of an inspection, preparing and hosting of FDA inspections are out-lined extensively. The importance of preparation is emphasized, ground rules for handling inspectors are provided, and consequences arising from FDA inspections are described.
At the beginning of this article, some basic remarks to FDA inspections in the current political climate are given. Finally, the experience of the pharmaceutical industry in the last two years (2002 and 2003) is provided together with an outlook for the future.
Key words FDA-Inspektionen, Industrieerfahrungen • GMP-Verletzungen • Inspektions-Management
pharmind 2004, Nr. 10, Seite 1260