Analytical Method Validation and Instrument Performance Verification
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Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan
Book DescriptionValidation 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 setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
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Book DetailsISBN: 9780471259534
(236mm x 162mm x 21mm)
Imprint: John Wiley & Sons Inc
Publisher: John Wiley & Sons Inc
Publish Date: 25-Feb-2004
Country of Publication: United States
Books By Author Chung Chow Chan
Therapeutic Delivery Solutions, Hardback (March 2013)
A comprehensive review of all types of medical therapeutic delivery solutions from traditional pharmaceutical therapy development to innovative medical device therapy treatment to the recent advances in cellular and stem cell therapy development. It also includes associated regulatory requirements for the development of these therapies.
Practical Approaches to Method Validation and Essential Instrument Qualification, Hardback (September 2010)» View all books by Chung Chow Chan
All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods.
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Author Biography - Chung Chow Chan
CHUNG CHOW CHAN is a Research Scientist at Eli Lilly Canada, Inc. Y. C. LEE is the associate director of Patheon YM, Inc., in Canada. HERMAN LAM is Manager of Automation and Lab Systems at Glaxo Smith Kline Canada. XUE-MING ZHANG is a Supervisor at Novex Pharma. Chung Chow, Herman, and Y. C. are the founders of the Calibration and Validation Group (CVG). CVG is a scientific organization based in Canada that focuses on the advancement of the sciences in method validation and instrument qualification.
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