John Wiley & Sons, Inc., 2004. – 315 p. Contents: Chung Chow Chan and Eric Jensen. Overview of Pharmaceutical Product Development and Its Associated Quality System Chung Chow Chan. Potency Method Validation Y. C. Lee. Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, and Y. C. Lee. Dissolution Method Validation Xue-Ming Zhang. Analysis of Pharmaceutical Inactive Ingredients Yoshiki Nishiyama. Validation Study of JP Heavy Metal Limit Test Fabio Garofolo. Bioanalytical Method Validation Herman Lam. Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview Herman Lam. Performance Verification of UV–Vis Spectrophotometers Herman Lam. Performance Verification of HPLC Nicole E. Baryla. Operational Qualification of a Capillary Electrophoresis Instrument Fabio Garofolo. LC-MS Instrument Calibration Rick Jairam, Robert Metcalfe, and Yu-Hong Tse. Karl Fisher Apparatus and Its Performance Verification Yu-Hong Tse, Rick Jairam, and Robert Metcalfe. The pH Meter and Its Performance Verification Gilman Wong and Herman Lam. Qualification of Environmental Chambers Ludwig Huber. Equipment Qualification and Computer System Validation Heiko Brunner. Validation of Excel Spreadsheet Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen Potency method validation / Chung Chow Chan Method validation for HPLC analysis of related substances in pharmaceutical drug products / Y.C. Lee Dissolution method validation / Chung Chow Chan ... [et al.]. Development and validation of automated methods / Chantal Incledon and Herman Lam Analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang Validation study of JP heavy metal limit test / Yoshiki Nishiyama Bioanalytical method validation / Fabio Garofolo Procurement, qualification, and calibration of laboratory instruments: an overview / Herman Lam Performance verification of UV-Vis spectrophotometers / Herman Lam Performance verification of HPLC / Herman Lam Operational qualification of a capillary electrophoresis instrument / Nicole E. Baryla LC-MS instrument calibration / Fabio Garofolo Karl Fisher apparatus and its performance verification / Rick Jairam, Robert Metcalfe, and Yu-Hong Tse The pH meter and its performance verification / Yu-Hong Tse, Rick Jairam, and Robert Metcalfe Qualification of environmental chambers / Gilman Wong and Herman Lam Equipment qualification and computer system valication / Ludwig Huber Validation of Excel spreadsheet / Heiko Brunner. 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. Pharmaceutical product development consists of a series of logical and systematic processes.
