Monday, 6 April 2020

Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing


A new book of interest has been published: Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing, edited by David Roesti and Marcel Goverde

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.

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.

I am please to have contributed a chapter:

Sandle, T. (2020) Utilities Design and Testing. In Roesti, D. and Goverde, M. (Eds.) Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing, Wiley, USA, pp189 - 230

The book is available from Amazon.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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