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How to Validate a Pharmaceutical Process
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How to Validate a Pharmaceutical Process, part of the Expertise in Pharmaceutical Process Technology series, provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. This latest entry in the series addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. It contains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more. This book illustrates the methods and reasoning behind processes and protocols. Understanding the “why” 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 literatureAddresses practical problems and offers solutions to qualify and validate a pharmaceutical processIllustrates the most common issues related to developing and implementing a sustainable process validation program and provides valuable examples on how to be successfulContains numerous case studies throughout and covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more
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