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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Description du livre État : New. Depending on your location, this item may ship from the US or UK. N° de réf. du libraire 97815749107970000000
Description du livre CRC Press, 2017. Hardback. État : NEW. 9781574910797 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Print on Demand title, produced to the highest standard, and there would be a delay in dispatch of around 10 working days. N° de réf. du libraire HTANDREE0173753
Description du livre Taylor and Francis, 1998. HRD. État : New. New Book. Shipped from US within 10 to 14 business days. Established seller since 2000. N° de réf. du libraire VT-9781574910797
Description du livre Informa Healthcare, 1998. Hardcover. État : Brand New. 1st edition. 443 pages. 11.00x8.50x1.00 inches. In Stock. N° de réf. du libraire __1574910795
Description du livre CRC Press, 1998. Hardcover. État : New. N° de réf. du libraire P111574910795
Description du livre CRC Press, 1998. Hardcover. État : New. book. N° de réf. du libraire 1574910795