LEADER 03903oam 2200649 a 450 001 9910140857303321 005 20240104164530.0 010 $a1-118-06031-8 010 $a1-282-88344-5 010 $a9786612883446 010 $a0-470-63071-X 010 $a0-470-63070-1 035 $a(CKB)2670000000055605 035 $a(EBL)675009 035 $a(OCoLC)730151616 035 $a(SSID)ssj0000425852 035 $a(PQKBManifestationID)11265194 035 $a(PQKBTitleCode)TC0000425852 035 $a(PQKBWorkID)10372217 035 $a(PQKB)11439011 035 $a(MiAaPQ)EBC4445027 035 $a(MiAaPQ)EBC675009 035 $a(Au-PeEL)EBL675009 035 $a(CaPaEBR)ebr10469614 035 $a(CaONFJC)MIL288344 035 $a(EXLCZ)992670000000055605 100 $a20100113d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aPractical approaches to method validation and essential instrument performance verification /$fedited by Chung C. Chan, Herman Lam, Xue-Ming Zhang 210 $aHoboken, N.J. $cWiley$dc2010 215 $a1 online resource (415 pages) 300 $aComplement to: Method validation and instrument performance verification / edited by Chung Chow Chan ... [et al.]. c2004. 311 0 $a0-470-12194-7 320 $aIncludes bibliographical references and index. 327 $a(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. 330 $a"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. 606 $aDrugs$xAnalysis$xMethodology$xEvaluation 606 $aLaboratories$xEquipment and supplies$xEvaluation 606 $aLaboratories$xInstruments$xEvaluation 615 0$aDrugs$xAnalysis$xMethodology$xEvaluation. 615 0$aLaboratories$xEquipment and supplies$xEvaluation. 615 0$aLaboratories$xInstruments$xEvaluation. 676 $a615/.1901 701 $aChan$b Chung Chow$0870448 701 $aLam$b Herman$0967184 701 $aZhang$b Xue-Ming$0967185 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910140857303321 996 $aPractical approaches to method validation and essential instrument performance verification$92195679 997 $aUNINA