Analytical Method Validation and Instrument Performance Verification

Chung Chow Chan

ISBN 10: 0471259535 / ISBN 13: 9780471259534

Editore: Wiley Jan 2004, 2004

Riguardo questo articolo

Neuware - 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.

Codice articolo 9780471259534

Dati bibliografici

• Titolo: Analytical Method Validation and Instrument Performance Verification
• Editore: Wiley Jan 2004
• Data di pubblicazione: 2004
• Lingua: Inglese
• ISBN 10: 0471259535
• ISBN 13: 9780471259534
• Rilegatura: Buch
• Condizione: Neu
• Dimensioni: 240 L x 161 A x 22 P (millimetri) 240 millimetri di larghezza per 161 millimetri di altezza per 22 millimetri di profondità
• Peso: 648 grammi

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.