11. GMP goes GxP-Konferenz
14. AMG Novelle / Qualified Person und sachkundige Person nach § 14 AMG / Risk and Science Based Approach - Update ICH Q8, Q9, Q10
Bericht von einer Konferenz der Hochschule Albstadt-Sigmaringen, mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS Training Service, Arnsberg, am 16./17. November 2005 in Potsdam
Reinhard Schnettlera, Prof. Dr. Ingrid Müllerb, Prof. Dr. Heinz Theo Schneiderb, Walter Friec und Cornelia Wawretscheka
PTS Training Servicea, Arnsberg, Hochschule Albstadt-Sigmaringenb, und Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalenc, Düsseldorf
The major item to be discussed during this annual conference titled GMP goes GXP was the 14. amendment to the German Drug Law. This law was introduced in 1976 and modified several times in this period because of changing requirements. The current issue contains be-side others also requirements of the EU-directive 2001/ 83 for a qualified person. Because of its importance this mayor change was discussed by the conference participants as well as the expected following modifications of the German PharmBetrV.
Cost reduction demands and high governmental regulations are opposite to the requirements for continuously improving product quality. In order to minimize quality risks, improve process capability and reduce compliance risks the ICH-Guidelines Q8- Q10 Pharmaceutical Devel-opment, Quality Risk Management and Quality Systems, can give orientation by using Process Analytical Technology (PAT) and Six-Sigma-System. On a long term perspective this also will result in significant cost reductions.