Analytical Method Validation and Instrument Performance Verification

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. Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment. Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibration scientists, and research and development scientists.