John Wiley And Sons Analytical Method Validation And Instrument Calibration -Ddu
Tze-Fun Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang
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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