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1、PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)OMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENT歐洲委員會(huì)OMCL網(wǎng)絡(luò)質(zhì)量管理文件PA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT設(shè)備的確認(rèn)ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1：HPLC(高效液相色譜儀)設(shè)備的確認(rèn)Fulldocumenttitleandreference文件全名和索引號(hào)Q
2、ualificationofEquipment設(shè)備的確認(rèn)Annex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04附件1：HPLC設(shè)備的確認(rèn)PA/PH/OMCL(11)04Documenttype文件類型Guideline指南Legislativebasis立法基礎(chǔ)ThepresentdocumentwasalsoacceptedbyEAasrecommendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLs本文件也被EA
3、認(rèn)可并推薦在OMCL的質(zhì)量管理體系審計(jì)中使用。Dateoffirstadoption首次采用日期May20052005年5月Dateoforiginalentryintoforce首次生效日期June20052005年6月Dateofentryintoforceofreviseddocument修訂版生效日期1stJuly20112011年7月1號(hào)Previoustitles/otherreferences原文件名/其它索引號(hào)ThisdocumentreplacesdocumentPA/PH/OMCL(07)17DEF本文件替代文件PA/PH/OMCL(0
4、7)17DEF1stJuly2011Page18of18PA/PH/OMCL(11)04-OMCLGuidelineonqualificationofHPLCequipment(Annex1)CustodianOrganisation監(jiān)管組織ThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEurope本文件由OMCL網(wǎng)絡(luò)/歐洲EDQM制定。ConcernedNetwork相關(guān)網(wǎng)絡(luò)GEONANNEX1OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIO
5、NOFEQUIPMENT”O(jiān)MCL網(wǎng)絡(luò)指南“設(shè)備的確認(rèn)”之附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC設(shè)備的確認(rèn)Introduction概述ThepresentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment”,anditshouldbeusedincombinationwithitwhenplanning,performinganddocumentingtheHPLCequipmentqualificationprocess.本文件是核心文件“設(shè)備
6、的確認(rèn)”第1個(gè)附件，在計(jì)劃、實(shí)施和記錄HPLC儀器的確認(rèn)過程時(shí)，應(yīng)將本文件與核心文件一起使用。ThecoredocumentcontainsthegeneralintroductionandtheLevelIandIIofqualification,commontoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument-relatedrecommendationsonparameterstobecheckedandthecorrespondingtypicalacceptanceLimit
7、s,aswellaspracticalexamplesontheMethodologythatcanbeusedtocarryoutthesechecks.核心文件包括了簡(jiǎn)介和第一階段和第二階段的確認(rèn)，它們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(biāo)準(zhǔn)的推薦，以及可用于進(jìn)行這此檢查的實(shí)用方法學(xué)舉例。WhenqualifyingHPLCequipment,itshouldbenotedthatitisacceptabletocheckatLevelIIIandIVseveralofthementionedparame
8、tersatthesametimeinacombinedtestp
