【英文标准名称】:StandardGuideforProcessUnderstandingRelatedtoPharmaceuticalManufactureandControl
【原文标准名称】:与药物制造和控制相关的工艺理解的标准指南
【标准号】:ASTME2475-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010
【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】:control;pharmaceuticalmanufacture;processunderstanding
【摘要】:1.1Thepurposeofthisguideistoestablishaframeworkandcontextforprocessunderstandingforpharmaceuticalmanufacturingusingqualitybydesign(QbD)(Juran,1992;FDA/ICHQ8).Theframeworkisapplicabletobothactivepharmaceuticalingredient(API)andtodrugproduct(DP)manufacturing.High(detailed)levelprocessunderstandingcanbeusedtofacilitateproductionofproductwhichconsistentlymeetsrequiredspecifications.Itcanalsoplayakeyroleincontinuousprocessimprovementefforts.1.2ProcessAnalyticalTechnology(PAT)isoneelementthatcanbeusedforachievingcontroloverthoseinputsdeterminedtobecriticaltoaprocess.ItisimportantforthereadertorecognizethatPATisdefinedas:
【中国标准分类号】:C10
【国际标准分类号】:11_120_01
【页数】:6P.;A4
【正文语种】:英语