FDA-Inspektionen von Arzneimittel-und Wirkstoffherstellern
Dr. Reiner Kirrstetter und Dr. Kurt E. Moerck
Sanofi-Aventis Deutschland GmbH, Global Quality Audit, Frankfurt/Main
FDA Inspections of Manufacturers of Drugs and Active Pharmaceutical Ingredients
The main topics of FDA inspections based on the integrated quality system-based approach are described in detail. GMP deficiencies that FDA has found when inspecting each system are presented with examples.
As the inspection management of a company has a direct influence on the results of an inspection, preparing and hosting of FDA inspections are outlined extensively. The importance of preparation is emphasized, ground rules on how to deal with inspectors are provided, and consequences arising from FDA inspections are described. At the beginning of the article, some basic remarks concerning FDA inspections in the current political climate are given. Finally, the experience of the pharmaceutical industry in the last few years is provided together with a look into the future.