9. GMP goes GxP-Konferenz
Wissenschaft und Technik des Prozeßmanagements: Process Analytical Technologie (PAT) / Risked Based Approach / Validierung und Real Time Release (Parametrische Freigabe)
Bericht von einer Konferenz der Hochschule für Wirtschaft und Technik, Sigmaringen, mit der DGGF (Deutsche Gesellschaft für Gute Forschungspraxis) und PTS Training Service, A rnsberg, am 21./22. Oktober 2003 in Berlin
Reinhard Schnettler und Cornelia Wawretschek
Mayor aspects of the FDA‘s strategy change in order to realize the official requirements are a risk-base approach and also the consideration of economical aspects.
To include the pharmaceutical industry into the process of developing new regulations is a surprising and great advantage. The objectives of this new initiative are to develop and implement new technologies in the pharmaceutical industry in order to get efficient processes for the production of secure and better quality products.
The European Authorities are facing the challenges because of the upcoming expansion of the EU in May 2004. In Germany we are awaiting the introduction of the new GCP-regulations, and a 12. amendment to the German Drug Law (AMG) has been presented.
The biotechnology has currently a strong increas-ing importance for the pharmaceutical companies because of its fast growing markets. Therefore the biotechnology also was one of the key elements of this 9. GMP-Conference.