Ostrove - Equipment Qualification in the Pharmaceutical Industry, Ostrove, Steven
Автор: Steven Ostrove Название: How to Properly Validate a Pharmaceutical Process ISBN: 012804148X ISBN-13(EAN): 9780128041482 Издательство: Elsevier Science Рейтинг: Цена: 6230.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
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 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 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
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario.
No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
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