欧盟OMCL仪器确认附件1-HPLC确认.pdf

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1、BEIJINGGELEGSCI.-TECH.CO.LTDOMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENTPA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT仪器确认ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1：HPLC仪器的确认FulldocumenttitleandreferenceQualificationofEquipment文件全名和索引号Annex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04D

2、ocumenttype文件类型Guideline指南Legislativebasis立法基础ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoptionMay2005首次发行日期DateoforiginalentryintoforceJune2005首次执行日期Dateofentryintoforceofrevised1stJuly2011document修订

3、后执行日期Previoustitles/otherreferencesThisdocumentreplacesdocumentPA/PH/OMCL(07)17DEF原文件名/其它索引号CustodianOrganisationThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEurope保管机构ConcernedNetworkGEON相关网络BEIJINGGELEGSCI.-TECH.CO.LTDANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFE

4、QUIPMENT”OMCL网络指南“仪器的确认”之附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC仪器的确认Introduction概述ThepresentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheHPLCequipmentqualificationprocess.本文件是核心文件“仪器的确认”第1个附件，在计

5、划、实施和记录HPLC仪器的确认过程时，应将本文件与核心文件一起使用。ThecoredocumentcontainsthegeneralintroductionandtheLevelIandIIofqualification,commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimits,aswellaspracticale

6、xamplesontheMethodologythatcanbeusedtocarryoutthesechecks.核心文件包括了第一级和第二级确认的通用介绍，适用于所有类型的仪器，本附件包括了HPLC仪器相关的需要检查的参数和相应典型的可接受标准的推荐，以及可用于进行这此检查的实用方法学举例。WhenqualifyingHPLCequipment,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparametersatthesametimeinacombinedtes

7、tprocedure(e.g.“overall”systemperformancetestgivinginformationonpeakareaprecision,retentiontimeprecision,gradientreproducibility,etc).在进行HPLC仪器确认时，应注意也可以对第三级和第四级几个提到的参数采用联合检测程序同时进行检查（例如“全面”系统性能检查，同时给出峰面积精密度、保留时间精密度、梯度重复性等的信息）TABLEIII表三LevelIII.Periodicandmotivatedin