Erfolgreiche Prozessvalidierung als Voraussetzung der industriellen Fertigung von Arzneimitteln Hagen Trommer und Henning Mallwitz HERMAL Kurt Herrmann GmbH & Co. OHG, Reinbek Korrespondenz: Dr. Hagen Trommer, HERMAL Kurt Herrmann GmbH & Co. OHG, Produktentwicklung − RxPE, Scholtzstr. 3, 21465 Reinbek (Germany), e-mail: hagen.trommer@hermal.de Successful Process Validation as a Requirement for the Industrial Manufacturing of Drugs The entering of the process validation concept into the pharmaceutical industry was a trend reversal in industrial drug manufacturing. The understanding and the control of manufacturing processes came to the fore. In the last few years further quality assurance elements were developed additionally to process validation. The following article explains the importance of process validation for industrial drug manufacturing. The different types of process validation are elucidated as well as the concept behind the term. Finally, the significance of process validation is discussed considering the novel quality concept developments. Process validation is assessed as still an essential quality assurance tool in pharmaceutical industry. Key words Lebenszyklus-Konzept • Process Analytical Technology (PAT) • Prozessvalidierung • Qualitätsmanagement • Risikoanalyse • Statistische Prozesskontrolle |
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pharmind 2008, Nr. 2, Seite 301
