Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

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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.The recommended testing for content uniformity, assays, degradation and impurity methods, and dissolution methods are listed in Table 5.3. Equivalency. This test compares the results of the automated procedure with the results of the validated manual method. If accuracy of the ... Manual versus automated methods.

Title:Analytical Method Validation and Instrument Performance Verification
Author:Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang
Publisher:John Wiley & Sons - 2004-04-23


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