How to Validate a Pharmaceutical Process

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology, Science & Nature, Mathematics, Statistics
Cover of the book How to Validate a Pharmaceutical Process by Steven Ostrove, PhD, Elsevier Science
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Author: Steven Ostrove, PhD ISBN: 9780128096536
Publisher: Elsevier Science Publication: June 7, 2016
Imprint: Academic Press Language: English
Author: Steven Ostrove, PhD
ISBN: 9780128096536
Publisher: Elsevier Science
Publication: June 7, 2016
Imprint: Academic Press
Language: English

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
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

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