Release Date: 01 March, 2003
Hardcover
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From Book News, Inc.
The new edition of this classroom text and desk reference recognizes that pharmaceutical process validation was not an American invention, as many in the field have assumed, but rather that many of the fundamental concepts originated in Switzerland and Germany during the 1980s. The third edition includes new chapters on validation for medical devices, in biotechnology processes, in integrated packaging, and in contract manufacturing, transdermal process validation, statistical methods for uniformity and dissolution testing, change control and SUPAC (scale up and post approval changes), and harmonization and GMPs. The 34 contributors include research and industry specialists from the U.S., Europe and Japan.Copyright © 2004 Book News, Inc., Portland, OR
Book Description
Banner Pharmacaps, Elizabeth, New Jersey. Drugs and the Pharmaceutical Sciences, Volume 57. New edition of a text for pharmaceutical researchers and manufacturers on good manufacturing practice and the applicability of process validation. 31 U.S. contributors. DNLM: Drug Evaluation standards - United States. --This text refers to the Hardcover edition.
Book Info
Stevens Institute of Technology, Hoboken, NJ. Details strategies to establish appropriate validation protocols and conduct process validation assignments, monitor and test specific manufacturing processes for compliance with design limits, and more. Rating
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