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1、BEIJINGGELEGSCI.-TECH.CO.LTDOMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENTPA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT儀器確認ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1：HPLC儀器的確認FulldocumenttitleandreferenceQualificationofEquipment文件全名和索引號Annex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04D
2、ocumenttype文件類型Guideline指南Legislativebasis立法基礎(chǔ)ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoptionMay2005首次發(fā)行日期DateoforiginalentryintoforceJune2005首次執(zhí)行日期Dateofentryintoforceofrevised1stJuly2011document修訂
3、后執(zhí)行日期Previoustitles/otherreferencesThisdocumentreplacesdocumentPA/PH/OMCL(07)17DEF原文件名/其它索引號CustodianOrganisationThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEurope保管機構(gòu)ConcernedNetworkGEON相關(guān)網(wǎng)絡(luò)BEIJINGGELEGSCI.-TECH.CO.LTDANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFE
4、QUIPMENT”O(jiān)MCL網(wǎng)絡(luò)指南“儀器的確認”之附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC儀器的確認Introduction概述ThepresentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheHPLCequipmentqualificationprocess.本文件是核心文件“儀器的確認”第1個附件，在計
5、劃、實施和記錄HPLC儀器的確認過程時，應(yīng)將本文件與核心文件一起使用。ThecoredocumentcontainsthegeneralintroductionandtheLevelIandIIofqualification,commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimits,aswellaspracticale
6、xamplesontheMethodologythatcanbeusedtocarryoutthesechecks.核心文件包括了第一級和第二級確認的通用介紹，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)典型的可接受標準的推薦，以及可用于進行這此檢查的實用方法學(xué)舉例。WhenqualifyingHPLCequipment,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparametersatthesametimeinacombinedtes
7、tprocedure(e.g.“overall”systemperformancetestgivinginformationonpeakareaprecision,retentiontimeprecision,gradientreproducibility,etc).在進行HPLC儀器確認時，應(yīng)注意也可以對第三級和第四級幾個提到的參數(shù)采用聯(lián)合檢測程序同時進行檢查（例如“全面”系統(tǒng)性能檢查，同時給出峰面積精密度、保留時間精密度、梯度重復(fù)性等的信息）TABLEIII表三LevelIII.Periodicandmotivatedin
