Analytical Method Validation & Instrument Calibration
Analytical Method Validation & Instrument Calibration
Authors(s): Chung C Chan (Editor), Y. C Lee (Editor), Herman Lam (Editor), Xue-Ming Zhang (Editor)
Hardcover: 303 pages ; Dimensions (in inches): 1.00 x 9.25 x 6.25
Publisher: Wiley-Interscience; (January 23, 2004)
Book Descripton:
Eli Lilly Canada, Inc, Ontario. Provides a practical approach to method validation and instrument performance verification. Covers validation for pharmaceutical excipients, heavy metals, and bioanalysis; proper environmental environmental chamber qualification, and more. For research and development scientists. DNLM: Chemistry, Pharmaceutical–instrumentation.
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.
Teaches proper procedures for using tools and analytical methods in a regulated lab setting.
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.
