Good Manufacturing Practice (GMP)
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Home > Medicine & Health Science textbooks > Medical specialties, branches of medicine > Pharmacology > Good Manufacturing Practice (GMP) Teil 1: Historische Entwicklung, EU-GMP-Leitfaden, Kernelemente(essentials)
Good Manufacturing Practice (GMP) Teil 1: Historische Entwicklung, EU-GMP-Leitfaden, Kernelemente(essentials)

Good Manufacturing Practice (GMP) Teil 1: Historische Entwicklung, EU-GMP-Leitfaden, Kernelemente(essentials)


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About the Book

Dieses essential stellt die historische Entwicklung der Guten Herstellungspraxis (GMP), die derzeitigen Regelwerke und wichtige GMP-Kernaspekte vor. Das übergeordnete Ziel der GMP-Vorgaben ist die Standardisierung der Anforderungen und die Minimierung von Fehlerpotenzialen zur Sicherstellung der Produktqualität und der Patientensicherheit. Diese Anforderungen sind erfahrungsbasiert und werden ständig weiterentwickelt. Die Arzneimittel-Hersteller verfügen über eine Vielzahl von Systemen zur Sicherstellung der Arzneimittelqualität und stehen unter regelmäßiger behördlicher Überwachung.

Der Inhalt

  • 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


Table of Contents:

Entwicklung der Arzneimittelregulation inkl. der GMP-Regelwerke.- EU-GMP-Leitfaden und GMP-Literatur.- Kernelemente des GMP.- Zusammenfassung und Aussicht GMP.



About the Author :

Patric U. B. Vogel ist im GMP/Pharma/Biotech-Bereich als Berater selbstständig und publiziert regelmäßig in den Bereichen GMP, analytische Methoden, Infektionskrankheiten und Statistik.


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Product Details
  • ISBN-13: 9783662738405
  • Publisher: Springer-Verlag Berlin and Heidelberg GmbH & Co. KG
  • Publisher Imprint: Springer-Verlag Berlin and Heidelberg GmbH & Co. K
  • Height: 210 mm
  • No of Pages: 48
  • Returnable: N
  • Returnable: N
  • Returnable: N
  • Returnable: N
  • Series Title: essentials
  • Width: 148 mm
  • ISBN-10: 3662738406
  • Publisher Date: 08 Aug 2026
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Returnable: N
  • Returnable: N
  • Returnable: N
  • Returnable: N
  • Sub Title: Historische Entwicklung, EU-GMP-Leitfaden, Kernelemente


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