Description
Summary: | Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab s.
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Physical Description: | 1 online resource (x, 303 pages) : illustrations |
Bibliography: | Includes bibliographical references and index. |
ISBN: | 047146371X 9780471463719 9780471463726 0471463728 0471259535 9780471259534 |
Source of Description, Etc. Note: | Print version record. |