3 Review(s)

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. Table of Contents Contributors. Preface. Overview of Pharmaceutical Product Development and Its Associated Quality System (C. Chan & E. Jensen). Potency Method Validation (C. Chan). Method Validation for HPLC Analysis of Related Substances in Pharmaceutical Drug Products (Y. Lee). Dissolution Method Validation (C. Chan, et al.). Development and Validation of Automated Methods (C. Incledon & H. Lam). Analysis of Pharmaceutical Inactive Ingredients (X. Zhang). Validation Study of JP Heavy Metal Limit Test (Y. Nishiyama). Bioanalytical Method Validation (F. Garofolo). Procurement, Qualification, and Calibration of Laboratory Instruments: An Overview (H. Lam). Performance Verification of UV-Vis Spectrophotometers (H. Lam). Performance Verification of HPLC (H. Lam). Operational Qualification of a Capillary Electrophoresis Instrument (N. Baryla). LC-MS Instrument Calibration (F. Garofolo). Karl Fisher Apparatus and Its Performance Verification (R. Jairam, et al.). The pH Meter and Its Performance Verification (Y. Tse, et al.). Qualification of Environmental Chambers (G. Wong & H. Lam). Equipment Qualification and Computer System Validation (L. Huber). Validation of Excel Spreadsheet (H. Brunner). Index.