Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

Book Details

  • Published: 23 January 2020
  • ISBN: 978-1-119-35607-3
  • Author: David Roesti, Marcel Goverde
thumbnail image: Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing

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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

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Magazine of Chemistry Europe (16 European Chemical Societies)published by Wiley-VCH