How to Validate a Pharmaceutical Process

ISBN: 9780128041482 出版年：2016 页码：219 Ostrove, Steven Academic Press_RM

How to Validate a Pharmaceutical Process provides a 鈥渉ow to聰 approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the 鈥渨hy聰 is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.Thoroughly referenced and based on the latest research and literatureIllustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successfulCovers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more