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