03283nam a2200385 a 4500 ebr10469614 CaPaEBR m u cr cn||||||||| 100113s2010 njua sb 001 0 eng d 2009054243 9780470121948 (hbk.) 9780470630709 (e-book) CaPaEBR CaPaEBR (OCoLC)732958459 RS189 .P66 2010eb 615/.1901 22 Practical approaches to method validation and essential instrument performance verification [electronic resource] / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang. Hoboken, N.J. : Wiley, c2010. xiv, 399 p. : ill. Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004. Includes bibliographical references and index. (Publisher-supplied data ) Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems (LIMS) / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction. "The objective of this book is provide information in same practical, hands-on manner as the first book "Analytical Method Validation and Instrument Performance Verification", on important, but more advance topics. It will focus on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testings. These tests will generate reliable data that is in compliance with current Good Manufacturing Practices (cGMP) and will follow Good Analytical Practices"--Provided by publisher. Electronic reproduction. Palo Alto, Calif. : ebrary, 2011. Available via World Wide Web. Access may be limited to ebrary affiliated libraries. Drugs Analysis Methodology Evaluation. Laboratories Equipment and supplies Evaluation. Laboratories Instruments Evaluation. Electronic books. local Chan, Chung Chow. Lam, Herman. Zhang, Xue-Ming. ebrary, Inc. http://site.ebrary.com/lib/rucke/Doc?id=10469614 An electronic book accessible through the World Wide Web; click to view 114819 114819