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GMP-Basis Auflage II Grundlagenwissen für Tätigkeiten in der Pharmaindustrie.: Pharmacy/Biotech/ATMP/Medical-Device/QM
Paperback
Publisher: Independently Published
Published: Sep 22 2025
Pages: 222
Weight: 0.58
Height: 0.47 Width: 5.50 Depth: 8.50
Language: German
- Die detaillierte Betrachtung von Rohstoffe mischen und dosieren führt Sie in die entscheidenden Anfangsphasen der Produktion ein, wo Präzision und Kontrolle grundlegend für die Qualität des Endprodukts sind.
- Ein völlig neues Kapitel widmet sich dem Einhalten strenger Hygienevorschriften, einschlie lich der Herausforderungen und Besonderheiten der Sterilproduktion. Dies unterstreicht die unbedingte Notwendigkeit einer keimfreien Umgebung, um die Sicherheit der Patienten zu gewährleisten.
- Die Erläuterung von CIP & SIP (automatisierte Reinigungsverfahren) bietet Einblicke in modernste Reinigungstechnologien, die Effizienz und Prozesssicherheit in automatisierten Anlagen garantieren.
- Das Kapitel Die Herstellung pharmazeutischer Erzeugnisse wurde erheblich erweitert und behandelt nun detailliert die Fertigung verschiedener Darreichungsformen - von Tabletten und Salben über Pulver bis hin zu komplexen Injektionslösungen.
- Qualitätsmanagement, Arbeitsorganisation und Teamarbeit sowie Die Mess-, Steuerungs- und Regelungstechnik wurden nicht nur als neue Kapitel eingeführt, sondern umfassend beleuchtet. Sie bilden das Rückgrat jeder erfolgreichen und sicheren Pharmaproduktion und sind entscheidend für die Einhaltung regulatorischer Anforderungen wie der Guten Herstellungspraxis (GMP). Die Bedeutung von Umweltschutz und Nachhaltigkeit in diesem Kontext wird ebenfalls hervorgehoben.
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