How to Validate a Pharmaceutical Process (Expertise in Pharmaceutical Process Technology)
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9780128041482, Academic Press, Ostrove PhD, Steven
Original price was: $46.92.$27.60Current price is: $27.60.
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Author: Ostrove PhD, Steven
Brand: Academic Press
Edition: 1
ISBN: 9780128041482
Release Date: 21-06-2016
Package Dimensions: 9.0 x 5.9 x 0.5 inches
Languages: English
Binding: Paperback
Number Of Pages: 218
Details: 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 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 literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful 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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