  | Book Details Title: Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing |
Book DescriptionFrom the Back Cover A practical guide to microbiological quality and assurance for non-sterile drug manufacturing Pharmaceutical Microbiological Quality Assurance and Control offers a thorough and practical guide for professionals working in the field of non-sterile drug manufacturing. Drawing on the authors’ experience working in the field, the book contains a thorough and up-to-date approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Comprehensive in scope, the book covers state-of-the-art microbiology quality assurance and control (QA / QC) tests as well as risk mitigation strategies. The book is designed so that professionals can implement the methodologies presented in a facility or laboratory to meet current microbiology manufacturing best practices. In addition, the authors (noted experts on the topic) discuss developments in microbiological testing technology. The authors have years of experience practicing microbiological QA/QC in large multinational pharmaceutical companies and therefore present real-life complex cases involving tough decision-making. This important book: Offers a comprehensive guide to non-sterile pharmaceuticals microbiological QA/QC Contains the most recent developments in both regulatory expectations and technical advancements Provides information on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience Pharmaceutical Microbiological Quality Assurance and Control is written for microbiologists and those in charge of microbiological quality, primarily working in pharmaceutical companies of every size and specialty in positions including those within: microbiology laboratories, QA/QC departments, outsourcing departments, regulatory departments, and health regulatory authorities. Read more 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. Read more Customers Review:Most books on Pharmaceutical Microbiology simply quote the regulations and provide no information on what the regulations mean, rendering them as pretty useless books. This book is a rare exception!! The authors provide a true commentary of the regulations, solutions to real problems companies face and lots of practical application information. This is a must have for microbiology managers and supervisors who need help navigating the regulations. I am new to my supervisory role of a micro lab and this book has become my best friend. I gave it four stars because I wish they had gone more in depth on USP <51> Antimicrobial Effectiveness Testing. This is a critical area I would have really liked them to cover in depth. Besides that, great content! | |
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