Product Description
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.

CUSTOMER REVIEWS (Average Customer Rating: 4.5 based on 2 reviews)

WOW, Pretty good guide to begin

This book had some good things of what a person may look into and for when starting to Validate Pharmaceutical Equipment. There are so many example references to actual equipment that one could almost hear them running in their processes. It did not contain everything, but it sure did open one's eyes as to what to be aware of.

I did use this book in one instance for a non-pharmaceutical validation and its format helped me through it to a successful conclusion.

Overall, I was well pleased with this selection of mine. It's a great source for variety... makes you think a bit. This was good.
November 09, 2006

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

Actual and concrete, if qualification is the target this book has the right way to think to do it. Fortunately right on time thanks to Amazon.com
March 26, 2006

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