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How to Validate a Pharmaceutical Process by Steven Ostrove, Paperback | Indigo Chapters
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How to Validate a Pharmaceutical Process by Steven Ostrove, Paperback | Indigo Chapters
From Steven Ostrove
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How to Validate a Pharmaceutical Processprovides a how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in theExpertise in Pharmaceutical Process TechnologySeries, this bookillustrates 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 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 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 | How to Validate a Pharmaceutical Process by Steven Ostrove, Paperback | Indigo Chapters