Privatsphäre-Einstellungen

16. GMP-Konferenz: Risikomanagement, Sterilfertigung, Compliance

Good Distribution Practice (GDP) / Neuerungen in den GMP-Regularien / GMP-Aspekte von Pharmawasser / Risikomanagementsysteme / Fälschung von Arzneimitteln / Annex 1 / Kosten senken durch Compliance

Bericht von einer Konferenz der Hochschule Albstadt-Sigmaringen mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS Training Service am 22./23. November 2010 in München

Reinhard Schnettler¹, Prof. Dr. Ingrid Müller² und Cornelia Wawretschek¹

PTS Training Service¹, Arnsberg, und Hochschule Albstadt-Sigmaringen²

16th GMP Conference: Risk Management, Sterile Production, Compliance

By implementation of the ICH-Guideline “Pharmaceutical Quality System” to the EU-GMP-Guide, Quality Risk Management will be a part of the general requirements. Until now the application of the Quality Risk Management of Annex 20 has been an option in order to provide the manufacturer with internationally acknowledged tools for Risk Management methods. Because of the wide range of possibilities for application, Quality Risk Management became an integrated part of all Quality Risk Management Systems.
With the revised Annex 1 a new era in sterile production began. By emphasizing the importance of Quality Risk Management, the responsibility of the active personal increased. At the same time their scope of action was not limited by detailed statutory provisions.
The number of falsified pharmaceutical products has increased extremely all over the world. Also in the EU the amount of confiscated medicinal products has been risen drastically. Because of these incidents the EU is preparing a Regulation against falsification of pharmaceuticals.
The conference was concluded with several discussion groups and round tables.