Pharmaceutical Microbiological Quality Assurance and Control (Hardcover)
David Roesti
ISBN 10: 1119356075 ISBN 13: 9781119356073
Published by John Wiley & Sons Inc, New York, 2020
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About this Item
Description:
Hardcover. 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/QCPresents the latest developments in both regulatory expectations and technical advancementsProvides guidance on statistical tools for risk assessment and trending of microbiological dataDescribes strategy and practical examples from the authors experience in globalized pharmaceutical companies and expert networks This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Seller Inventory # 9781119356073
Synopsis:
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
About the Author:
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.
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Bibliographic Details
Title: Pharmaceutical Microbiological Quality ...
Publisher: John Wiley & Sons Inc, New York
Publication Date: 2020
Binding: Hardcover
Condition: new