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EU-GMP- Annex 1-2022 mit deutscher Übersetzung, Tipps und Hinweise: Leitlinie zur Herstellung steriler Arzneimittel
Paperback
Technology & EngineeringChemistry
Publisher: Independently Published
Published: Jan 21 2024
Pages: 278
Weight: 1.07
Height: 0.58 Width: 7.00 Depth: 10.00
Language: German
Zielsetzung, Zielgruppe und Aufbau dieses Buches
Dieses Buch richtet sich gezielt an Fachkräfte und Mitarbeiter mit entsprechendem Hintergrundwissen im Bereich der sterilen Produktion. Darüber hinaus ist es ein wertvolles Nachschlagewerk für neue Mitarbeiterinnen und Mitarbeiter verschiedener Fachbereiche in der Pharmaproduktion - darunter Engineering, Quality Control (QC), Quality Assurance (QA), Research & Development (R&D), Produktion, Validierung, Regulatory Affairs sowie der Reinraum-Instandhaltung.
- Prozess- und Qualitätsgrundlagen in der sterilen Produktion: Grundlageninformationen sollen den Leserinnen und Lesern dabei helfen, ihr Wissen zu vertiefen und zu erweitern.
- Chronologische Struktur: Die regulatorischen Anforderungen und Richtlinien sind entlang des Originaltextes logisch und chronologisch geordnet.
- Originaltext in englischer Sprache: Jeder Abschnitt führt zunächst den unverfälschten englischen Wortlaut des offiziellen Regelwerks an.
- Die Besonderheit des Annexes 1/2022 ist, dass diese Version gemeinsam durch EMA (EU), PIC/S und WHO erstellt wurde und somit eine weltweite Harmonisierung erreicht wurde. Die wichtigsten Themen des neuen Annex 1/2022 sind:
- QRM (Quality Risk Management)
- CCS (Contamination Control Strategy)
- Monitroring & Kontrolle
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