Publications

Risikomanagement in der Pharmaindustrie

Risikomanagement in der Pharmaindustrie

ISBN: 978-3-87193-361-5
Auflage/Erscheinungsjahr: 2006
Umfang: 215 Seiten

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Die aktuelle Ausgabe Risikomanagement in der Pharmaindustrie beschreibt praxisnah Grundlagen und Umsetzungsmöglichkeiten des Risikomanagements im
pharmazeutischen Umfeld. Die entsprechenden regulatorischen Vorgaben werden erläutert, und zahlreiche Fallbeispiele zeigen, wie sich die Vorgaben in der betrieblichen Praxis erfolgreich umsetzen lassen. Darüber hinaus werden die Möglichkeiten des IT-gestützten Risikomanagements beschrieben sowie eine Reihe von Risikomanagement-Tools vorgestellt und bewertet.


Modern Lyo Cycle Optimization

“Hot” and “Cold” Spot Determination by Wireless Real-Time Temperature Measurement as Process Analytical Technology (PAT) Tool.

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See poster presentation during the annual meeting of the Pharmaceutical Society of Japan reflecting our cooperation with iQ-mobil regarding freeze-drying.

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Risikomanagement in der Pharmaindustrie

Risk Management in the Pharmaceutical Industry

ISBN: 978-3-87193-370-7
1. Edition 2008
168 Pages

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This present issue of GMP REPORT contains papers dealing with selected aspects of risk management concerning pharmaceutical enterprises. Methods and tools are described with the industry-specific environment of their use. But the topic is dealt with not only from the point of view of pharmaceutical companies and not only by authors thereof. One article comes from an authority representative and describes an example of risk-based inspections by authorities. Another specialised paper lets the reader learn about the use of electronic data processing tools, their advantages, limitations and impacts. This GMP REPORT will also illuminate some of the details and peculiarities arising from the real-life practice of risk management in the pharmaceutical industry, authorities, suppliers, consusltants, etc., often not clearly regulated by official documents. Here the reader can profit from the vast experience and knowledge of the authors.


ICP-OES Measurements

A recent example of our expertise has recently been published by Sandoz where CBA did the ICP-OES measurements that were part of the root cause analysis of a cause of immunogenicity


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