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Pharmaceutical Equipment Validation - The Ultimate Qualification Guidebook (Hardcover)
Loot Price: R6,420
Discovery Miles 64 200
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Pharmaceutical Equipment Validation - The Ultimate Qualification Guidebook (Hardcover)
Expected to ship within 12 - 17 working days
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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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