FDA-Initiative zur Process Analytical Technology
Challenge und Chance für die Pharmaindustrie in Europa
Dr. Stephan Küppers1 und Christian Wölbeling2
Forschungszentrum Jülich GmbH1, Jülich, und Werum Software & Systems AG2, Lüneburg
The PAT-initiative and the new risk based approach of the FDA for the 21st Century is an interdisciplinary and process oriented approach to the quality in production in the pharmaceutical industry. Because of the complexity of the approach a number of scientific and business organisations are involved in the PAT-initiative. In Europe the various disciplines have started communication on the topics of the PAT-initiative and the national organisations start to interact on a European basis. This paper tries to give a first overview on the current communication process and tries to offer information for newcomers to get started in the discussion process.
pharmind 2008, Nr. 1, Seite 55