The Ultimate Qualification Guidebook by Phil Cloud
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.
Pharmaceutical Equipment Validation contains 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.
Pharmaceutical Equipment Validation shows 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.
Pharmaceutical Equipment Validation also 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.
Contents
Appendices
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