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1、PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)OMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENTPA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT儀器確認(rèn)ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1：HPLC儀器的確認(rèn)Fulldocumenttitleandreference文件全名和索引號(hào)Qualificat
2、ionofEquipmentAnnex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04Documenttype文件類型Guideline指南Legislativebasis立法基礎(chǔ)ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次發(fā)行日期May2005
3、Dateoforiginalentryintoforce首次執(zhí)行日期June2005Dateofentryintoforceofreviseddocument修訂后執(zhí)行日期1stJuly2011Previoustitles/otherreferences原文件名/其它索引號(hào)ThisdocumentreplacesdocumentPA/PH/OMCL(07)17DEFCustodianOrganisation保管機(jī)構(gòu)ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMof
4、theCouncilofEuropeConcernedNetwork相關(guān)網(wǎng)絡(luò)GEON1stJuly2011Page18of18PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)ANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”O(jiān)MCL網(wǎng)絡(luò)指南“儀器的確認(rèn)”之附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC儀器的確認(rèn)Introduction概述Thepr
5、esentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheHPLCequipmentqualificationprocess.本文件是核心文件“儀器的確認(rèn)”第1個(gè)附件，在計(jì)劃、實(shí)施和記錄HPLC儀器的確認(rèn)過(guò)程時(shí)，應(yīng)將本文件與核心文件一起使用。Thecoredocumentcontains
6、thegeneralintroductionandtheLevelIandIIofqualification,commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimits,aswellaspracticalexamplesontheMethodologythatcanbe
7、usedtocarryoutthesechecks.核心文件包括了第一級(jí)和第二級(jí)確認(rèn)的通用介紹，適用于所有類型的儀器，本附件包括了HPLC儀器相關(guān)的需要檢查的參數(shù)和相應(yīng)典型的可接受標(biāo)準(zhǔn)的推薦，以及可用于進(jìn)行這此檢查的實(shí)用方法學(xué)舉例。WhenqualifyingHPLCequipment,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparametersatthesametimeinacombinedtestproce
8、dure(e.g.“overall”systemperformancetestgivinginformationonpeakareaprecision,retentiontimeprecision,gradientreproducibility,etc).在進(jìn)行HPLC儀器確認(rèn)時(shí)，應(yīng)注意也可以對(duì)第三級(jí)和第四級(jí)幾個(gè)提到
