Analytical Method Validation and Instrument Performance Verification (Hardcover)
Chung Chow Chan
Sold by CitiRetail, Stevenage, United Kingdom
AbeBooks Seller since 29 June 2022
New - Hardcover
Condition: New
Quantity: 1 available
Add to basketSold by CitiRetail, Stevenage, United Kingdom
AbeBooks Seller since 29 June 2022
Condition: New
Quantity: 1 available
Add to basketHardcover. 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. Provides a discussion of the regulatory requirements of FDA, ICH, Europe, and Japan as they pertain to calibration of instruments and validation of methods. This book offers practical tips on how to validate techniques. It explains why different approaches are necessary in biopharmaceutical and bioanalytical methods validation. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
Seller Inventory # 9780471259534
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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