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EU-GMP- Annex 1-2022 mit deutscher Übersetzung, Tipps und Hinweise: Leitlinie zur Herstellung steriler Arzneimittel by Bayegi, Parviz

EU-GMP- Annex 1-2022 mit deutscher Übersetzung, Tipps und Hinweise: Leitlinie zur Herstellung steriler Arzneimittel

by Parviz Bayegi
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Book cover type: Paperback
  • ISBN13: 9798873972463
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Independently Published
  • Publisher Imprint: Independently Published
  • Publication Date:
  • Pages: 230
  • Original Price: GBP 80.84
  • Language: German
  • Edition: N/A
  • Item Weight: 404 grams
  • BISAC Subject(s): Life Sciences / Biochemistry

Die Europ�ische Arzneimittel-Agentur (EMA) hat in Zusammenarbeit mit der PIC-Organisation und der US-amerikanischen FDA (cGMP) im Jahr 2022 eine neue EU-GMP-Richtlinie ver�ffentlicht, die ab 2023 in Kraft tritt. Der neue Anhang 1 ist deutlich umfangreicher als sein Vorg�nger und umfasst 59 Seiten mit 11 Kapiteln. Insbesondere Kapitel 8 mit seinen 139 Punkten zu spezifischen Produktionsverfahren stellt hohe Anforderungen an die Hersteller.

Dieses Buch dient als Ihr umfassender Leitfaden f�r den neuen Annex 1. In einem einf�hrenden Teil werden entscheidende Grundlagen wie die Unterschiede zwischen Steril & Aseptisch, Clean-Up & Recovery, Klassifizierung, Qualifizierung und Monitoring fundiert erl�utert.

Um das Verst�ndnis und die Umsetzung der komplexen Richtlinien zu erleichtern, wurde ein einzigartiges Drei-Spalten-Layout entwickelt:

  • Spalte 1: Der englische Originaltext des Annex 1.

  • Spalte 2: Die offizielle deutsche �bersetzung.

  • Spalte 3: Praxisnahe Erl�uterungen. Hier werden besonders komplexe Punkte durch zus�tzliche Erkl�rungen und konkrete Beispiele aus der Praxis verst�ndlich aufbereitet.

Mit dieser Struktur haben Sie den Originaltext, die �bersetzung und die notwendigen Praxishinweise stets griffbereit.

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