03903oam 2200649 a 450 991014085730332120240104164530.01-118-06031-81-282-88344-597866128834460-470-63071-X0-470-63070-1(CKB)2670000000055605(EBL)675009(OCoLC)730151616(SSID)ssj0000425852(PQKBManifestationID)11265194(PQKBTitleCode)TC0000425852(PQKBWorkID)10372217(PQKB)11439011(MiAaPQ)EBC4445027(MiAaPQ)EBC675009(Au-PeEL)EBL675009(CaPaEBR)ebr10469614(CaONFJC)MIL288344(EXLCZ)99267000000005560520100113d2010 uy 0engur|n|---|||||txtrdacontentcrdamediacrrdacarrierPractical approaches to method validation and essential instrument performance verification /edited by Chung C. Chan, Herman Lam, Xue-Ming ZhangHoboken, N.J. Wileyc20101 online resource (415 pages)Complement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004.0-470-12194-7 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.DrugsAnalysisMethodologyEvaluationLaboratoriesEquipment and suppliesEvaluationLaboratoriesInstrumentsEvaluationDrugsAnalysisMethodologyEvaluation.LaboratoriesEquipment and suppliesEvaluation.LaboratoriesInstrumentsEvaluation.615/.1901Chan Chung Chow870448Lam Herman967184Zhang Xue-Ming967185MiAaPQMiAaPQMiAaPQBOOK9910140857303321Practical approaches to method validation and essential instrument performance verification2195679UNINA