Ebook: Analytical method validation and instrument performance verification

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