Privatsphäre-Einstellungen

12. GMP-Konferenz

AMWHV / Risikomanagement / Annex 1 / Sachkundige Person − Rolle der Qualified Person

Bericht von einer Konferenz der Hochschule Albstadt-Sigmaringen, mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS-Training Service, Arnsberg, am 29./30. November 2006 in Düsseldorf

Reinhard Schnettler¹, Prof. Dr. Ingrid Müller², Walter Frie³ und Cornelia Wawretschek¹

PTS Training Service¹, Arnsberg, Hochschule Albstadt-Sigmaringen² und Ministerium für Arbeit, Gesundheit und Soziales³, Düsseldorf

The most important item to be discussed during this conference was the replacement of the German Pharmabetriebsverordnung (PharmBetrV) by the new Arzneimittel- und Wirkstoff-Herstellungs-Verordnung (AMWHV) and its very extensive changes.
Risc management becomes an important instrument of leadership and a part of quality assurance activities. One guiding principle therefore was the guideline Q 9 Risc Management established by the international Conference on Harmonisation (ICH).
The actual valid annex 1 to the EG-GMP-Guideline is currently under revision and its change will affect the definition of clean-room-classes and sterile products manufacturing procedures.
In order to comply with the requirements for share of responsibility of key personal and in particular for the Qualified Person big and middelsize companies are searching for solutions.