仪器确认_附件1_HPLC确认_中英文.doc

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1、PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)OMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENTPA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT仪器确认ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1：HPLC仪器的确认Fulldocumenttitleandreference文件全名和索引号Qualificat

2、ionofEquipmentAnnex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04Documenttype文件类型Guideline指南Legislativebasis立法基础ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次发行日期May2005

3、Dateoforiginalentryintoforce首次执行日期June2005Dateofentryintoforceofreviseddocument修订后执行日期1stJuly2011Previoustitles/otherreferences原文件名/其它索引号ThisdocumentreplacesdocumentPA/PH/OMCL(07)17DEFCustodianOrganisation保管机构ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMof

4、theCouncilofEuropeConcernedNetwork相关网络GEON1stJuly2011Page18of18PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)ANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”OMCL网络指南“仪器的确认”之附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC仪器的确认Introduction概述Thepr

5、esentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheHPLCequipmentqualificationprocess.本文件是核心文件“仪器的确认”第1个附件，在计划、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。Thecoredocumentcontains

6、thegeneralintroductionandtheLevelIandIIofqualification,commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimits,aswellaspracticalexamplesontheMethodologythatcanbe

7、usedtocarryoutthesechecks.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,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparametersatthesametimeinacombinedtestproce

8、dure(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