Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing
Marc S. Levine, Parvati Ramchandani, Stephen E. Rubesin, 1119356113, 1119356075, 9781119356110, 978-1119356110, 9781119356073, 978-1119356073, B082YQK6CM
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