Pharmaceutical Equipment Validation

No other book in print deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment -- and provides explicit instructions on how to achieve it! This pragmatic book is meant for action. Included are 38 protocol templates that you can immediately use as your own -- why reinvent the wheel? These templates are guaranteed to save hundreds of hours; and their use pays for the book a hundred-fold! More important, you will be confident, in fact, certain, that you have missed nothing.

The templates are extraordinarily useful because they are already completed, providing instant answers to most of your protocol writing and testing questions. The templates cover specific equipment types, such as: shell blenders, emulsifying mixers, shaker mixers, matrix mixers, etc. and provide accurate, industry acceptable equipment qualification protocols. They show you how to qualify each piece of equipment, step by step. If you have your own protocols, use these templates to check them for scope, accuracy, and completeness.

The protocol templates are key tools in this easy-to-read, quick-to-implement, extremely practical resource. 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 specifically produce the documentation. This invaluable book gives details on how to demonstrate compliance, what data to use, and how to produce the documentation. Pharmaceutical Equipment Validation's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a birds-eye view of what is coming next -- and they quickly guide you through the equipment evaluation.

Installation, operational, and performance qualifications of equipment are critical to effective process validation. This book provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. It also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. In exacting detail, it analyses the intended range of use, edges of failure, proven acceptable ranges for critical parameters, and experience ranges.

Pharmaceutical Equipment Evaluation provides hands-on techniques of qualifying pharmaceutical equipment to achieve FDA compliance. As such, it is a vital resource, and one you need on your bookshelf and at your fingertips every working day.

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