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.

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