Description: Pharmaceutical Process Validation : An International Edition, Hardcover by Berry, Ira R. (EDT); Wachter, Alfred H. (EDT); Nash, Robert A. (EDT), ISBN 0824708385, ISBN-13 9780824708382, Used Good Condition, Free shipping in the US 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 ., Europe and Japan. Annotation (c) Book News, Inc., Portland, OR ()
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Book Title: Pharmaceutical Process Validation : An International Edition
Number of Pages: 904 Pages
Language: English
Publication Name: Pharmaceutical Process Validation : an International
Publisher: CRC Press LLC
Publication Year: 2003
Subject: Industries / Pharmaceutical & Biotechnology, Pharmacology, Quality Control, Chemistry / General
Item Height: 0.9 in
Item Weight: 56.6 Oz
Type: Textbook
Author: Alfred H. Wachter
Subject Area: Science, Business & Economics, Medical
Item Length: 6 in
Item Width: 9 in
Series: Drugs and the Pharmaceutical Sciences Ser.
Format: Hardcover