欢迎来到天天文库
浏览记录
ID:1233065
大小:175.00 KB
页数:18页
时间:2017-11-09
《仪控系统机械设备抗震分析方法应用》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
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QualificationofEquipm
2、entAnnex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04Documenttype文件类型Guideline指南Legislativebasis立法基础ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次发行日期May2005Dateoforiginalentryint
3、oforce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/EDQMoftheCouncilofEuropeConcernedNetwor
4、k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ThepresentdocumentisthefirstAnnexofthecoredocumen
5、t“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,
6、commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimits,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H
7、PLC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”systemperformancetestgivinginformationonpeakareaprecision,r
8、etentiontimeprecision,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
此文档下载收益归作者所有