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Good Manufacturing Practice (Gmp) Teil 1: Historische Entwicklung, Eu-Gmp-Leitfaden, Kernelemente
Paperback
Series: Essentials
ISBN13: 9783662738405
Publisher: Springer
Published: Oct 28 2026
Pages: 48
Language: German
- Eine Einführung in die historische Entwicklung der Arzneimittelregulation inkl. der Grundsätze der Guten Herstellungspraxis sowie der Gründung von wichtigen Behörden und Institutionen
Eine kurze Darstellung der Struktur des EU-GMP-Leitfadens, dessen Themengebiete, Anhänge und Inhalte sowie weiterer Fachliteratur Eine Beschreibung verschiedener Kernaspekte, u.a. Dokumentation, Risikomanagement, Qualifizierung und Validierung
Ein kurzes Beispiel für den Lebenszyklus einer Anlage
Beispiele für stetige Weiterentwicklungen von GMP-Leitlinien
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