Privatsphäre-Einstellungen

8. GMP-Konferenz

Good Practices in Entwicklung, Zulassung, Herstellung / Prozeßmanagement als Element der Arzneimittelsicherheit / MRA mit den USA zur Zeit auf Eis

Bericht von einer Konferenz der Hochschule für Wirtschaft und Technik, Sigmaringen, und PTS Training Service, Arnsberg, mit DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und DPhG (Deutsche Pharmazeutische Gesellschaft) am 3./4. Dezember 2002 in Darmstadt

Reinhard Schnettler und Cornelia Wawretschek

Dr. Peter Herbst (verstorben am 12. Februar 2002) zum ehrenden Gedenken gewidmet

In the EU we currently have afford for a fundamental revision of the pharmaceutical regulations. A large amount of proposed changes and their revision by the involved committees will not lead to final regulations in 2005. The agreements for mutual recognition of inspections between the US and the EU are pending; because of other influences the evaluation of the European inspection systems by the Food and Drug Administration did not start yet.
The importance of „outsourcing“ is increasing rapidly in the Pharmaceutical business. Sections of manufacturing and testing activities are carried out by contractors. This is causing a lot of quality aspects.
The conference also focused on the chances and advantages of IT-documentation regarding quality assurance and handling of electronic application documentation (electronic Common Technical Dossier).
Additional focuses were world-wide trends in regulatory and GMP compliance as well as government inspections.