Privatsphäre-Einstellungen

14. GMP-Konferenz: GMP und Qualitätssysteme

Risikomanagement/GMP-Dokumentation und IT-Systeme/Revision des Annex 11 des EU-GMP-Leitfadens/GMP-Inspektionen bei Wirkstoff- und Arzneimittelherstellern

Bericht von einer Konferenz der Hochschule Albstadt-Sigmaringen mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS-Training Service am 01./02. Dezember 2008 in Nürnberg

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

PTS Training Service¹, Arnsberg, und Hochschule Albstadt Sigmaringen²

According to Annex 20 of the EU-Guideline the use of risk management in pharmaceutical companies is increasing. It is a preventive tool for process optimization and therefore increasingly used by Qualified Persons and batch release processes. It is also suitable for optimization in cases of deviations and changes and for handling of critical parameters regarding qualification and validation processes as well.
The intensified use of computerized systems and following consequences require the actualization of Annex 11 of the EU-Guideline. The draft revised version was adapted for present scientific standards includes the risk management principles and is focused on subjects like validation, electronic signature and batch release.
Additional major topics of this conference were the upcoming version of the Annex 1 for manufacture of sterile medicinal products and the draft version of the Annex 2 of the EU-Guideline for the manufacture of biological medicinal product for human use. Discussion terms and round tables were also parts of this conference.