欧盟OMCL仪器确认附件1-HPLC确认.doc

欧盟OMCL仪器确认附件1-HPLC确认.docworkoftheCouncilofEuropeQUAl_IT丫MANAGEMENTDOCUMENTPA/PH/OMCL(11)04QUALIFICATIONOFEQUIPMENT仪器确认ANNEX1:QUALIFICATIONOFHPLCEQUIPMENT附件1:HPLC仪器的确认Fulldocumenttitleandreferenee文件全名和索引号QualificationofEquipmentAnnex1:QualificationofHPLCequipmentPA/PH/OMCL(11)04Documenttype文件类型Guideline指南Legislativebasis立法基砒;mendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次发行日期May2005Dateoforiginalentryintoforce首次执行Fl期June2005Dateofentryintoforceofreviseddocument修订后执行H期1stJuly2011Previoustitles/otherreferences原文件名/其它索引号ThisdocumentreplacesdocumentPA/PH/OMCL(07)work/WORKGUIDELINE"QUALIFICATIONOFEQUIPMENFOMCL网络指南“仪器的确认”Z附件1QUALIFICATIONOFHPLCEQUIPMENTHPLC仪器的确认Introduction概述ThepresentdocumentisthefirstAnnexofthecoredocument“QualificationofEquipment;binationwithitwhenplanning,performinganddocument!“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。montoalltypeofinstruments,andthepresentannexcontainsHPLCinstrument・eptaneeLimits,,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。Whenqualify!ngHPLCequipment,binedtestprocedure(.“overall”systemperformaneetestgivinginformationonpeakareaprecision,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,同时给出峰而积精密度、保留时间精密度、梯度重复性等的信息)(gradienttest)配比准确度和精密度(梯度测试)Proportioningripple配比波动±5%±2•<%Injector进样器Volumeprecision进样量精密度Carry-over残留RSD<%seeAnnexI见附件1Autosampler自动进样器Thermostatting accuracy andprecision恒温准确度和精密度• ±3°uracy恒温准确度• ±2°CUV/DADdetectorUV/uracy波长准确度r2>±uracyemission波长发射准确度Sensitivity灵敏度±3nm±3nm±uracyofthesignal信号准确度Stabilityofthesignal信号稳定性seeAnnexI见附件1seeAnnexI见附件1RIDdetectorRID检测器Signal/