ASTM E2476-2009 影响到PAT过程的设计、制定及实施的制药业风险评定与风险控制的指南
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【英文标准名称】:StandardGuideforRiskAssessmentandRiskControlasitImpactstheDesign,Development,andOperationofPATProcessesforPharmaceuticalManufacture
【原文标准名称】:影响到PAT过程的设计、制定及实施的制药业风险评定与风险控制的指南
【标准号】:ASTME2476-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E55.01
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:criticalqualityattribute(CQA);manufacturing;ProcessAnalyticalTechnology(PAT);processunderstanding;riskmanagement
【摘要】:Thisguideisintendedtoprovideguidanceregardingtheuseofriskanalysisinthedevelopment,day-to-dayrunning,andcontinuousimprovementofpharmaceuticalprocessesincorporatingProcessAnalyticalTechnology(PAT).SincePATisdefinedasbeingx201C;risk-basedx201D;(seeFDAGuidanceforIndustry),itisimportantthataconsistentapproachtotheuseofriskmethodologiesisadopted,toensurerapidtransferofprocessunderstandingwithinthedevelopmentandmanufacturingteams,andtotheregulatorswherethatisappropriate.4.2Thisguidanceonlycoversthoseaspectsofriskassessmentrelatedtox201C;risktoproductquality.x201D;Otheraspects(suchasx201C;risktopatientx201D;)shouldbecoveredintheconventionalmanner.1.1ThisdocumentprovidesguidanceontheassessmentofriskstoproductqualitywithinandrelatedtoPATprocessesinthepharmaceuticalindustry.Itaddressesthoseriskstoproductqualityarisingfrom,associatedwith,identifiedby,ormodifiedbytheimplementationofPATinpharmaceuticaldevelopmentandmanufacturingforprimary,secondary,andbiotechsectorsoftheindustry.Itdoesnotreplacethoseassessmentsofriskcurrentlyundertakenbypharmaceuticalcompanies,butis,rather,anadditionalcomponentfocusedspecificallyupontheevaluationanddesignofPATprocesses.SeePracticeE2474,GuideE2500,andICHQ8.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Notethatsafetyinthiscontextreferstooperationalandoperatorsafety,nottopatientsafety.
【中国标准分类号】:C04
【国际标准分类号】:11_120_10
【页数】:11P.;A4
【正文语种】:英语
【原文标准名称】:影响到PAT过程的设计、制定及实施的制药业风险评定与风险控制的指南
【标准号】:ASTME2476-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E55.01
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:criticalqualityattribute(CQA);manufacturing;ProcessAnalyticalTechnology(PAT);processunderstanding;riskmanagement
【摘要】:Thisguideisintendedtoprovideguidanceregardingtheuseofriskanalysisinthedevelopment,day-to-dayrunning,andcontinuousimprovementofpharmaceuticalprocessesincorporatingProcessAnalyticalTechnology(PAT).SincePATisdefinedasbeingx201C;risk-basedx201D;(seeFDAGuidanceforIndustry),itisimportantthataconsistentapproachtotheuseofriskmethodologiesisadopted,toensurerapidtransferofprocessunderstandingwithinthedevelopmentandmanufacturingteams,andtotheregulatorswherethatisappropriate.4.2Thisguidanceonlycoversthoseaspectsofriskassessmentrelatedtox201C;risktoproductquality.x201D;Otheraspects(suchasx201C;risktopatientx201D;)shouldbecoveredintheconventionalmanner.1.1ThisdocumentprovidesguidanceontheassessmentofriskstoproductqualitywithinandrelatedtoPATprocessesinthepharmaceuticalindustry.Itaddressesthoseriskstoproductqualityarisingfrom,associatedwith,identifiedby,ormodifiedbytheimplementationofPATinpharmaceuticaldevelopmentandmanufacturingforprimary,secondary,andbiotechsectorsoftheindustry.Itdoesnotreplacethoseassessmentsofriskcurrentlyundertakenbypharmaceuticalcompanies,butis,rather,anadditionalcomponentfocusedspecificallyupontheevaluationanddesignofPATprocesses.SeePracticeE2474,GuideE2500,andICHQ8.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Notethatsafetyinthiscontextreferstooperationalandoperatorsafety,nottopatientsafety.
【中国标准分类号】:C04
【国际标准分类号】:11_120_10
【页数】:11P.;A4
【正文语种】:英语
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