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QualificationofEquipmentAnnex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04Documenttype 文件类型Guideline 指南Legislativebasis 立法基础ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次发行日期May2005Dateoforiginalentryintoforce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/EDQMoftheCouncilofEuropeConcernedNetwork相关网络GEONANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”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-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptaneeLimits,aswellaspracticalexamplesontheMethodologythatcanbeusedtocarryoutthesechecks.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,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparametersatthesametimeinacombinedtestprocedure(e.g.“overall”systemperformaneetestgivinginfor...
