Privatsphäre-Einstellungen

GCP-Inspektionen in Deutschland und Europa nach Implementierung der Direktive 2001/20/EG

Teil 3: Empfehlungen für Sponsoren*)

Dr. Birgit Ruhfus¹, Dr. Dieter Baier², Dr. Heiner Gertzen³, Dr. Claus Göbel⁴, Per-Holger Sanden⁵, Dr. Jürgen-Hans Schmidt⁶ und Dr. Dorette Schrag-Floß⁷

Bayer Schering Pharma AG¹, Berlin, Roche Pharma AG², Grenzach-Wyhlen, Sanofi-Aventis Pharma S. A³, Paris, Pfizer Pharma GmbH⁴, Karlsruhe, Merck Serono International SA⁵, Darmstadt, Sanofi-Aventis Pharma Deutschland⁶, Bad Soden, CSL Behring GmbH⁷, Marburg

Pharmaceutical companies are facing more and more systematic GCP inspections by European health authorities at the sponsor site. Such inspections require much more preparation and follow-up activities for the sponsor than investigator-site inspections. A working group of the German Association of Research-Based Pharmaceutical Companies (VFA, Verband Forschender Arzneimittelhersteller e.V., Berlin) presents an inspection-readiness guidance in the following article which provides support for the preparation, conduct and follow-up of such inspections. The inspection-readiness guidance is meant to provide guidance for supporting actual inspections as well as putting companies into the position of constant inspection-readiness, e.g. by using the topics listed for system audits.