Analytical Method Validation and Instrument Performance Verification

By: Chung Chow Chan (Editor), Y. C. Lee (Editor), Herman Lam (Editor), Xue-Ming Zhang (Editor)

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Hardcover | 14 January 2004 | Edition Number 1

At a Glance

Hardcover
320 Pages

Dimensions(cm)
23.6 x 16.35 x 2.35

Hardcover

RRP $317.85

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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 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.

Industry Reviews

?It is a treasure of helpful hints and techniques which can aid even experienced analysts through some of the ICH procedures.? (Metrohm Information, 4th July 2005)

"While most useful for pharmaceutical laboratories, it may also be useful in certain university and government laboratories." (E-STREAMS, February 2005)

"?a treasure of helpful hints and techniques that can aid even experienced analysts through some of the ICH procedures." (Inside Laboratory Management, July/August 2004)

"Given the need for generating reliable analytical data, this book provides practical guidance for validating common and not-so-common analytical methods and for verifying the performance of instruments?" (Journal of the American Chemical Society, June 9, 2004)

??a very useful reference text?warmly recommended? (Organic Process Research & Development Journal)

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