ASTM E2474-2006 利用过程分析技术进行制药过程设计的标准规程

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【英文标准名称】:StandardPracticeforPharmaceuticalProcessDesignUtilizingProcessAnalyticalTechnology
【原文标准名称】:利用过程分析技术进行制药过程设计的标准规程
【标准号】:ASTME2474-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【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】:E55.02
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:分析的;设计过程;医药品;工艺学
【英文主题词】:designspace;desiredstate;manufacturing;PAT;pharmaceuticalprocessdesign;processanalyticaltechnology;processunderstanding;qualityriskmanagement
【摘要】:1.1Thispracticecoversprocessdesign,whichisintegraltoprocessdevelopmentaswellaspost-developmentprocessoptimization.Itisfocusedonpracticalimplementationandexperimentaldevelopmentofprocessunderstanding.1.2Thetermprocessdesignasusedinthispracticecanmean:1.2.1Theactivitiestodesignaprocess(theprocessdesign),and/or1.2.2Theoutcomeofthisactivity(thedesignedprocess).1.3Theprinciplesinthispracticeareapplicabletobothdrugsubstanceanddrugproductprocesses.Fordrugproducts,formulationdevelopmentandprocessdevelopmentareinterrelatedandthereforetheprocessdesignwillincorporateknowledgefromtheformulationdevelopment.1.4Theprinciplesinthispracticeapplyduringdevelopmentofanewprocessortheimprovementorredesignofanexistingone,orboth.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C10
【国际标准分类号】:11_120_01
【页数】:3P.;A4
【正文语种】: