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portada How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology)
Type
Physical Book
Publisher
Author
Year
2016
Language
English
Pages
218
Format
Paperback
ISBN13
9780128041482
Edition No.
1
Categories

How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology)

Steven Ostrove Phd (Author) · Academic Press · Paperback

How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology) - Steven Ostrove Phd

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Synopsis "How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology) "

How to Validate a Pharmaceutical Process provides a “how to” 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 “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

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