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GMP-Risikoanalysen

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Brand
Springer Nature
Manufacturer
N/A
Part Number
0
GTIN
9783658352073
Condition
New
Product Description

Risikoanalysen sind Methoden des Qualittsrisikomanagements und nehmen eine wichtige Stellung ein. Der pharmazeutische Prozess umfasst verschiedene Bereiche, u.a. die Produktentwicklung, das regelkonforme Betreiben von Produktionsanlagen, die Beschaffung von Ausgangsmaterialien, die Fertigung von Produktchargen, die Prfung in der Qualittskontrolle, die berwachung der Einhaltung aller Regularien durch die Qualittssicherung, die Dokumentation und die Bewertung von Aufflligkeiten oder Abweichungen bis hin zur Lagerung und dem Vertrieb der Produkte. Risikoanalysen sind ein essenzielles Werkzeug, das auf alle diese Stufen und Bereiche angewendet wird. Das Ziel ist es Risiken zu identifizieren und zu bewerten, um durch geeignete Manahmen das Risiko ausreichend unter Kontrolle zu halten und damit die Produktqualitt sicherzustellen.

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