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.

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Yes, you can access Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang in PDF and/or ePUB format, as well as other popular books in Sciences physiques & Chimie industrielle et technique. We have over one million books available in our catalogue for you to explore.

Information

Publisher

Wiley-Interscience

Year

2004

ISBN

9780471463719

Edition

Topic

Sciences physiques

Subtopic

Chimie industrielle et technique

ANALYTICAL METHOD VALIDATION AND INSTRUMENT PERFORMANCE VERIFICATION