【英文标准名称】:StandardGuideforSpecification,Design,andVerificationofPharmaceuticalandBiopharmaceuticalManufacturingSystemsandEquipment
【原文标准名称】:制药学和生物制药学制造设备的规范、设计和认证用标准指南
【标准号】:ASTME2500-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:E55.03
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:设计;制造设备;制药技术;医药品;药剂学;认证
【英文主题词】:
【摘要】:Applicationoftheapproachdescribedwithinthisguideisintendedtosatisfyinternationalregulatoryexpectationsinensuringthatmanufacturingsystemsandequipmentarefitforintendeduse,andtosatisfyrequirementsfordesign,installation,operation,andperformance.TheapproachdescribedinthisguideappliesconceptsandprinciplesintroducedintheFDAinitiative,PharmaceuticalcGMPsforthe21stCenturyx2014;ARisk-BasedApproach.Thisguidesupports,andisconsistentwith,theframeworkdescribedinICHQ8andICHQ9.ThisguidemaybeusedindependentlyorinconjunctionwithotherproposedE55standardstobepublishedbyASTMInternational.1.1Thisguideisapplicabletoallelementsofpharmaceuticalandbiopharmaceuticalmanufacturingsystemsincluding:facilityequipment,processequipment,supportingutilities,associatedprocessmonitoringandcontrolsystems,andautomationsystemsthathavethepotentialtoaffectproductqualityandpatientsafety.1.2Forbrevity,thesearereferredtothroughouttherestofthisguideasmanufacturingsystems.1.3Thisguidemayalsobeappliedtolaboratory,information,andmedicaldevicemanufacturingsystems.1.4Thisguideisapplicabletobothnewandexistingmanufacturingsystems.Theapproachmaybeusedfortheimplementationofchangestoexistingsystems,andtheircontinuousimprovementduringoperation.1.5Thisguideisapplicablethroughoutthelife-cycleofthemanufacturingsystemfromconcepttoretirement.Thisstandarddoesnotaddressemployeehealthandsafety,environmental,orothernon-GxPregulations.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C90
【国际标准分类号】:11_120_99
【页数】:5P.;A4
【正文语种】: