文档介绍：201410PA/PH/OMCL(14)89结果的评估和报告---workoftheCouncilofEuropeQUALITYASSURANCEDOCUMENTPA/PH/OMCL(14)89EvaluationandReportingofResults结果的评估和报告Annex2AFulldocumenttitleandreferenceEvaluationandreportingofResults---Annex2AExamplesofRe-testProgrammesforQuantitativeTestsPA/PH/OMCL(14)89全名和索引结果的评估和报告---附录2A 定量检测项目的复验程序举例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”EXAMPLESOFRE-TESTPROGRAMMESFORQUANTITATIVETESTSTABLEOFCONTENTINTRODUCTION 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()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:验证数据不充分的产品Approach6:Re-testprogrammebasedonstatisticalassaylayouts()方法6:根据统计学含量布局制订的复验计划()Approach7:Re-testprogrammebasedonknownintermediateprecision方法7:根据已知中间精密度的复验程序Approach8:Approachforcasesofunexplainedlackofrepeatability方法8:缺乏重复性又不能解释情况下所用的方法   INTRODUCTION 概述ThisdocumentisanAnnextothecoredocument“Evaluationandreportingofresults”, PA/PH/OMCL(13)113(initscurrentversion),binationwithitwhenplanning,“结果的评估与报告”核心文件PA/PH/OMCL(13)113(现行版本)的附录。在计划、实施和记录符合正态分布的定量测试结果的评估过程和报告结果时要与核心文件一起使用。ThecoredocumentcontainstheIntroduction,ScopeandGeneralrequirementsfortheevaluationofresults(inroutinecasesorotherwise)(在常规情形还是其它情形)和报告的概述、范围和通用要求。Theproposedapproachesareonlyrelevantifthedecisionisbasedonobservedrepeatability[1].Inallcases,thelaborator