Analytical Method Validation and Instrument Performance Verification (Hardcover)

Chung Chow Chan

ISBN 10: 0471259535 / ISBN 13: 9780471259534

Editore: John Wiley & Sons Inc, New York, 2004

Riguardo questo articolo

Hardcover. 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 multiple locations in the US or from the UK, depending on stock availability.

Codice articolo 9780471259534

Dati bibliografici

• Titolo: Analytical Method Validation and Instrument Performance Verification (Hardcover)
• Editore: John Wiley & Sons Inc, New York
• Data di pubblicazione: 2004
• Lingua: Inglese
• ISBN 10: 0471259535
• ISBN 13: 9780471259534
• Rilegatura: Hardcover
• Edizione: prima edizione
• Condizione: new

Descrizione articolo

Riassunto

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.

Informazioni sull?autore

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.