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| FDA im Aufbruch: GMP-Initiative zur Arzneimittelqualität für das 21. Jahrhundert Abschlußbericht vom September 2004 und Konsequenzen Dr. Reiner Kirrstetter sanofi aventis Gruppe, Technical Quality and Compliance Expertise, Frankfurt/Main The goals of the GMP initiative for drug product quality are outlined. The FDA intends to minimize the health risks for US people by optimizing the approval and inspection processes. Pharmaceutical industry should be encouraged to focus on continuous improvement, early adoption of new technological advances, and pharmaceutical innovations. Process understanding and risk-based decisions are key. The FDA achievements made during the project and at the end of two years are described in details. More than 15 documents were issued to demonstrate FDA’s current thinking and procedures. The FDA plan for meeting the needs of tomorrow is presented as well as the expectations of industry towards this US Agency. |
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pharmind 2005, Nr. 1, Seite 46
