Analytical Method Validation and Instrument Performance Verification

Chan

ISBN 10: 0471259535 / ISBN 13: 9780471259534

Published by John Wiley & Sons Inc, 2004

About this Item

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. Editor(s): Chan, Chung Chow; Lee, Y. C.; Lam, Herman; Zhang, Xue-Ming. Num Pages: 320 pages, index. BIC Classification: PDN; PN; TDCW. Category: (P) Professional & Vocational. Dimension: 236 x 162 x 21. Weight in Grams: 586. . 2004. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.

Seller Inventory # V9780471259534

Bibliographic Details

• Title: Analytical Method Validation and Instrument Performance Verification
• Publisher: John Wiley & Sons Inc
• Publication Date: 2004
• Language: English
• ISBN 10: 0471259535
• ISBN 13: 9780471259534
• Binding: Hardcover
• Condition: New

About this title

Synopsis

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.

About the Author

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.