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Funktionsträger Im Gmp-Umfeld: Leiter Der Qualitätskontrolle, Leiter Der Herstellung Und Qualified Person
Paperback
Series: Essentials
ISBN13: 9783662687192
Publisher: Springer
Published: Feb 16 2024
Pages: 57
Weight: 0.20
Height: 0.14 Width: 5.83 Depth: 8.27
Language: German
Per Gesetz und Verordnung müssen pharmazeutische Unternehmen diverse sog. Funktionsträger benennen und beschäftigen. Hierzu zählen u.a. der Leiter der Qualitätskontrolle, der Leiter der Herstellung und die Sachkundige Person, die auch als Qualified Person bezeichnet wird. Diese Funktionsträger erfüllen wichtige Aufgaben im GMP-Umfeld, die u.a. dazu dienen, die Produktqualität von Arzneimitteln und damit die Patientensicherheit zu gewährleisten. Diese Funktionsträger sind zentraler Dreh- und Angelpunkt aller Aktivitäten, die zur Erfüllung der GMP-Anforderungen bei der Herstellung und Prüfung erfolgen.
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