Qualitätsmanagement-Systeme vor dem Hintergrund aktueller regulatorischer Anforderungen Dr. Heinrich Prinz PDM-Consulting, Groß-Zimmern Corresponding author: Dr. Heinrich Prinz, PDM-Consulting, Zur Viehweide 4 a, 64846 Groß-Zimmern (Germany), e-mail: heinrich_prinz@web.de Quality Management Systems on the Background of Current Regulatory Requirements Quality Management Systems are nowadays a common part in pharmaceutical companies to assure the quality of pharmaceutical products and drugs. In the years 2006 and 2007 two main regulatory requirements were published pointing out a new direction integrated new elements never mentioned beforehand. This publication intends to demonstrate which new elements have to be implemented for a robust and modern Quality Management System and where to be supported during interpretation. Key words Qualitätsmanagement-System • ICH Q 10 • FDA Quality System Guide • DIN EN ISO 9001:2000 |
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pharmind 2009, Nr. 6, Seite 1024
