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TechnicalReportNo.88技术报告第88号MicrobialDataDeviationInvestigationsinthePharmaceuticalIndustry制药行业的微生物数据偏差调查TableofContents目录1.0Introduction............................................................5简介..................................51.1.Purpose...................................................................5目的.................................51.2.Scope.......................................................................6范围...................................62.0GlossaryofTerms..................................................7术语表...............................72.1.Abbreviations/Acronyms......................................9缩写/首字母缩略词..............93.0MicrobiologistRolesandResponsibilities...............9微生物学家的角色和职责.................93.1.LaboratoryMicrobiologistResponsibilities...........9实验室微生物学家的职责.................103.2.MicrobiologistRoleinaManufacturingInvestigation.....................................................10微生物学家在制造调查中的作用.........103.3.MicrobiologyLaboratoryManagementResponsibilities.................................................11微生物实验室管理职责................113.4.SubjectMatterExpertResponsibilities...............11主题专家的职责........................113.5.QualityControlUnitResponsibilities..................12质量控制部门职责.....................124.0PhaseI:ConductingtheMicrobiologyLaboratoryInvestigation..................................12第一阶段：进行微生物实验室调查......124.1.Microbialldentification........................................17微生物鉴定..........................174.2.PhaseI:SpecificPointstoConsider....................19第一阶段：需要考虑的具体要点.........194.2.1.SterilityTestingInvestigations.............................19无菌检测调查........................194.2.2.BacterialEndotoxinsTestingInvestigations........25细菌内毒素检测调查..................254.2.3.AntimicrobialEffectivenessTestingInvestigations...................................................28抗菌有效性测试调查....................284.2.4.MycoplasmaTestingInvestigations....................29支原体检测调查........................294.2.5.BiologicalIndicatorsInvestigations....................31生物指标调查..........................314.2.6.AsepticProcessSimulationFailures(MediaFills)....................................................................32无菌过程模拟失败(培养基填充).........324.2.7.EnvironmentalMonitoring..................................33环境监测..........................334.2.8.UtilitiesMonitoring............................................34公用事业监控........................344.3.PhaseI:ConclusionandNextSteps...................36第一阶段：结论和后续步骤............365.0Phasell:ManufacturingInvestigation....................37第二阶段：制造调查..................375.1.RootCauseAnalysis...........................................39根本原因分析........................395.2.PhaseIl:SpecificPointstoConsider..................45第二阶段：需要考虑的具体要点..........465.2.1.Sterility-PositiveInvestigations...........................46无菌阳性调查..........................465.2.2.DeterminingSourcesofBacterialEndotoxin·48确定细菌内毒素的来源..................485.2.3.PharmaceuticalIngredient-RelatedInvestigations....................................................49药物成分相关调查...