EU-GMP- Annex 1-2022 mit deutscher Übersetzung, Tipps und Hinweise: Leitlinie zur Herstellung steriler Arzneimittel
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Allein das Kapitel 8 für Produktion und spezifische Technologien beinhaltet 139 Punkte. Um die komplexen Texte und Anforderungen aus diesem neuen EU-GMP Annex 1-2022 zu verstehen, wurde in diesem Buch neben dem originalen Text in Englisch und eine fachliche deutsche Übersetzung, befinden sich auch in der dritten Spalte praxisbezogene Hinweise zu den jeweiligen Anforderungen des Annex 1.
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