201410PA/PH/OMCL(14)workoftheCouncilofEuropeQUALITYASSURANCEDOCUMENTPA/PH/OMCL(14)89EvaluationandReportingofResults结果得评估与报告Annex2AFulldocumenttitleandreferenceEvaluationandreportingofResultsAnnex2AExamplesofRetestProgrammesforQuantitativeTestsPA/PH/OMCL(14)89全名与索引结果得评估与报告附录2A 定量检测项目得复验程序举例PA/PH/OMCL(14)89DocumenttypeGuideline文件类型指南Legislativebasis/法规依据无DateoffirstadoptAugust2014首次采纳日期2014年8月DateoforiginalentryintoforceOctober2014首次实施日期2014年10月Dateofentryintoforceofreviseddocument/修订版生效日期无Previoustitles/otherreferences/lastvalidversion/之前题目/其它索引号/work/EDQMoftheCouncilofEurope责任机构现行文件由欧盟委员会EDQM/workGEON相关网络GEON ANNEXIIA WORKGUIDELINE“EVALUATIONANDREPORTINGOFRESULTS”EXAMPLESOFRETESTPROGRAMMESFORQUANTITATIVETESTSTABLEOFCONTENTINTRODUCTION 概述Approach1:Activepharmaceuticalingredient,2initialdeterminations方法1:原料药,2次初始检测Approach2:Activepharmaceuticalingredient,3initialdeterminations方法2:原料药,3次原始检测Approach3:Impuritytests(e、g、RelatedsubstancesbyHPLC)方法3:杂质检测 (例如HPLC检测有关物质)Approach4:Finishedproducts方法4:制剂检测Approach5:Productswithinsufficientvalidationdata方法5:验证数据不充分得产品Approach6:Retestprogrammebasedonstatisticalassaylayouts(Ph、Eur、5、3)方法6:根据统计学含量布局制订得复验计划(欧洲药典5、3)Approach7:Retestprogrammebasedonknownintermediateprecision方法7:根据已知中间精密度得复验程序Approach8:Approachforcasesofunexplainedlackofrepeatability方法8:缺乏重复性又不能解释情况下所用得方法 INTRODUCTION 概述ThisdocumentisanAnnextothecoredocument“Evaluationandreportingofresults”, PA/PH/OMCL(13)113(initscurrentversion),anditshouldbeusedinbinationwithitwhenplanning,performinganddocumentingtheevaluationprocessandreportingofresultsofquantitativetestswiththeexpectedGaussiandistribution、本文件就是“结果得评估与报告”核心文件PA/PH/OMCL(13)113(现行版本)得附录。在计划、实施与记录符合正态分布得定量测试结果得评估过程与报告结果时要与核心文件一起使用。ThecoredocumentcontainstheIntroduction,ScopeandGeneralrequirementsfortheevaluationofresults(inroutinecasesorotherwise)andthereportingofresults、核心文件包括结果评估(在常规情形还就是其它情形)与报告得概述、范围与通用要求。Theproposedapproachesareonlyrelevantifthedecisionisbasedonobservedrepeatability[1]、Inallcases,thelaboratorys
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