Pharmaceutical Microbiological Quality Assurance and Control (ePub)
Practical Guide for Non-Sterile Manufacturing
(Sprache: Englisch)
Relying on practical examples from the authors' experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.
* Offers a comprehensive...
* Offers a comprehensive...
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Produktinformationen zu „Pharmaceutical Microbiological Quality Assurance and Control (ePub)“
Relying on practical examples from the authors' experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.
* Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC
* Presents the latest developments in both regulatory expectations and technical advancements
* Provides guidance on statistical tools for risk assessment and trending of microbiological data
* Describes strategy and practical examples from the authors' experience in globalized pharmaceutical companies and expert networks
* Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC
* Presents the latest developments in both regulatory expectations and technical advancements
* Provides guidance on statistical tools for risk assessment and trending of microbiological data
* Describes strategy and practical examples from the authors' experience in globalized pharmaceutical companies and expert networks
Autoren-Porträt
David Roesti, PhD, works at Novartis Pharma AG in Stein, Switzerland, and is responsible for defining the microbial control strategy at the site and is a global subject matter expert in microbiology for the Novartis group. He is also is an elected member of the General Chapters Microbiology Expert Committee of the Unites States Pharmacopoeia 2015-2020 revision cycle.Marcel Goverde, PhD, runs MGP Consulting GmbH for consulting, training and project management in GMP-relevant areas with a focus on microbiology, hygiene and deviation management. He is the Swiss expert in the EDQM group for Modern Microbiological Methods since 2003, which was then integrated into Group 1 (Microbiological Methods and Statistical Analysis) in 2015.
Bibliographische Angaben
- 2019, 1. Auflage, 592 Seiten, Englisch
- Herausgegeben: David Roesti, Marcel Goverde
- Verlag: John Wiley & Sons
- ISBN-10: 1119356121
- ISBN-13: 9781119356127
- Erscheinungsdatum: 02.12.2019
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
eBook Informationen
- Dateiformat: ePub
- Größe: 18 MB
- Mit Kopierschutz
Sprache:
Englisch
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