How to Validate a Pharmaceutical Process

• Main Author: Ostrove, Steven A. (Author)
• Format: Book
• Language: English
• Published: AMSTERDAM ELSEVIER 2016
• Series: Expertise in pharmaceutical process technology series
• Subjects: Drug Industry > standards; Quality Control; Legislation, Drug
• Online Access: Click Here to View Status and Holdings.
• Physical Description: xviii, 199 pages illustrations, portrait 23 cm
• Bibliography: Includes bibliographical references and index
• ISBN: 9780128041482; 012804148X

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.