Gebundenes Buch

Analytical Method Validation and Instrument Performance Verification

Beschreibung

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.

Autor

CHUNG CHOW CHAN is a Research Scientist at Eli Lilly Canada, Inc. 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.

Produktdetails

• Wiley-Interscience
• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 320
• Erscheinungstermin: 28. Januar 2004
• Englisch
• Abmessung: 240mm x 161mm x 22mm
• Gewicht: 578g
• ISBN-13: 9780471259534
• ISBN-10: 0471259535
• Artikelnr.: 13785467

Rezensionen

"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 )