Practical Approaches to Method Validation and Essential Instrument Qualification

All regulated laboratories, including pharmaceutical, clinical testing, food and cosmetic laboratories, must properly execute the calibration of instruments and validation of analytical methods. Advance Technologies in Instrumentation, Qualification, Performance, Verification and Analytical Methods Validation skillfully explains important, but advanced, techniques of method validation and instrument performance. The book covers validation of methods for significant new or evolving procedures, such as proteomic assays, rapid microbial identification, and process analytical technologies, making this text a must–read for analysts, scientists, engineers, technologists, and technical managers.

Spis treści:
Chapter 1 Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification.
Chapter 2 Phase Appropriate Method Validation.
Chapter 3 Analytical Method Verification, Method Revalidation, and Method Transfer.
Chapter 4 Validation of PAT Applications.
Chapter 5 The Validation of Near Infrared Systems for Raw Material Identification.
Chapter 6 Cleaning Validation.
Chapter 7 Risk Based Validation of laboratory Information Management Systems (LIMS).
Chapter 8 Performance Qualification and Verification of Balance.
Chapter 9 Performance Verification of NIR Spectrophotometers.
Chapter 10 Operational Qualification in Practice for Gas Chromatography Instruments.
Chapter 11 Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection.
Chapter 12 Instrument Qualification and Performance Verification for Particle Size Instruments.
Chapter 13 Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers.
Chapter 14 Instrument Performance Verification – Micro Pipettes.
Chapter 15 Instrument Qualification and Performance Verification for Automated Liquid Handling Systems.
Chapter 16 Performance Qualification and Verification in Powder X–ray Diffraction.