在当今的科学发展飞速的新时代,越来越多的高科技开始运用于我们的学习、工作和生活当中。科技,已成为我们走向高质量生活的一座桥梁,一根绳梯。ofvision.3,build,fittinginwiththeurbanmasterplaninYibincityrapidrailtransitlongtermnetwork,aswellasthevisionofYibincity,andfuturedevelopmentofrailtransitnetwork.4,Yibincity,preliminaryrailtrafficlevelsservicelevels,systemmodel,andtechnicalstandards.5,toensurethatnetworkcanbeimplemented.6,stableconditionsforplanningandsupportingofYibincitytracktrafficconstructionandformationofrailtransitindustry,provideconditionsforthestart-upanddevelopmentofrailtransitinYibincity.1.7technicalcoursetechnologyistheproject'sresearchprogramandresearchideas.Technologyreflectsthevariousstagesintheprocess,logicalrelationsbetweenvariouslevels,research,techniquesandphases.Networkplanningprocessthewholeprocesscanbedividedintofourparts,namely,backgroundresearch,networkarchitectureresearch,planningandimplementationofresearchandprogramminginterfaces.Figure1.7-1Yibincityrailtransitnetworkplanningtechnologyroadmapplanninginterfaceismainlyresponsiblefornetworkplanninginterfacewithfollow-upplanningtasks.NetworkplanningUrbanplanningsysteminatransitionalposition,onlinenetworkplanningiscompleted,willbecarriedoutassoonaspossiblethefollowingplanningprojects:1,detailedcontrolofthelandofrapidrailtransitnetworkplanning;2,thepartitioningfornetworkplanning;3,jointplanningofrailtransportandurbantransportinotherways;Detailedtechnicalcoursesseebelow.Figure1.7-2Generaltechnologyroutefigure2ndchapterCitystatusanddevelopmentplanning2.1citybasicprofile2.1.1美国FDACGMP英汉对照版SubpartA-GeneralProvisions§211.1Scopea)Theregulationsinthispartcontaintheminimumcurrentgoodmanufacturingpracticeforpreparationofdrugproductsforadministrationtohumansoranimals.b)Thecurrentgoodmanufacturingpracticeregulationsinthischapter,astheypertaintodrugproducts,andinparts600through680ofthischapter,astheypertaintobiologicalproductsforhumanuse,shallbeconsideredtosupplement,notsupersede,theregulationsinthispartunlesstheregulationsexplicitlyprovideotherwise.Intheeventitisimpossibletocomplywithapplicableregulationsbothinthispartandinotherpartsofthischapterorinparts600through680ofthischapter,theregulationspecificallyapplicabletothedrugproductinquestionshallsupersedetheregulationinthispart.c)Pendingconsiderationofaproposedexemption,publishedintheFederalRegisterofSeptember29,1978,therequirementsinthispartshallnotbeenforcedforOTCdrugproductsiftheproductsandalltheiringredientsareordinarilymarketedandconsumedashumanfoods,andwhichproductsmayalsofallwithinthelegaldefinitionofdrugsbyvirtueoftheirintendeduse.Therefore,untilfurthernotice,regulationsunderpart110ofthischapter,andwhereapplicable,parts113to129ofthischapter,shallbeappliedindeterminingwhethertheseOTCdrugproductsthatarealsofoodsaremanufactured,processed,packed,orheldundercurrentgoodmanufacturingpractice.§211.3Definitions.Thedefinitionssetforthin§210.3ofthischapterapplyinthispart.A.总则211.1范围(a)本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范(GMP)。(b)在本章里的这些针对药品的现行GMP条例和本章600~680部分的所有针对人用生物制品的现行GMP条例,除非明确另有说明外,应认为是对本部分条例的补充,而不是代替。本章其他部分或本章600~680g各部分均可适用的条例,前部分的条例可以代替本部分条例。(c)在考虑经提议的,发表在1978年9月29日联邦注册表(FR)上一项免除时,若产品及其所有成分是以人用物品形式作一般销售和消费,且这些产品根据其预期用途,亦可列入药品的范围,则不应对这些非处方药(OTC)实施本部分条例,直至进一步的通知为止。本章110部分和113至119部分的条例用于鉴别这些亦是食品的OTC药品是否按照GMP的要求生产、加工、包装&贮存。211.3定义本章211.3中的定义使用于本部分。goodmanufacturingpractice(GMP)良好的生产管理规范over-the-counter(OTC)人用非处方药per`tain适合,属于expli`citly明白地,确切地super`sede代替,取代,延期ex`emption解除,免除,免税在当今的科学发展飞速的新时代,越来越多的高科技开始运用于我们的学习、工作和生活当中。科技,已成为我们走向高质量生活的一座桥梁,一根绳梯。ofvision.3,build,fittinginwiththeurbanmasterplaninYibincityrapidrailtransitlongtermnetwork,aswellasthevisionofYibincity,andfuturedevelopmentofrailtransitnetwork.4,Yibincity,preliminaryrailtrafficlevelsservicelevels,systemmodel,andtechnicalstandards.5,toensurethatnetworkcanbeimplemented.6,stableconditionsforplanningandsupportingofYibincitytracktrafficconstructionandformationofrailtransitindustry,provideconditionsforthestart-upanddevelopmentofrailtransitinYibincity.1.7technicalcoursetechnologyistheproject'sresearchprogramandresearchideas.Technologyreflectsthevariousstagesintheprocess,logicalrelationsbetweenvariouslevels,research,techniquesandphases.Networkplanningprocessthewholeprocesscanbedividedintofourparts,namely,backgroundresearch,networkarchitectureresearch,planningandimplementationofresearchandprogramminginterfaces.Figure1.7-1Yibincityrailtransitnetworkplanningtechnologyroadmapplanninginterfaceismainlyresponsiblefornetworkplanninginterfacewithfollow-upplanningtasks.NetworkplanningUrbanplanningsysteminatransitionalposition,onlinenetworkplanningiscompleted,willbecarriedoutassoonaspossiblethefollowingplanningprojects:1,detailedcontrolofthelandofrapidrailtransitnetworkplanning;2,thepartitioningfornetworkplanning;3,jointplanningofrailtransportandurbantransportinotherways;Detailedtechnicalcoursesseebelow.Figure1.7-2Generaltechnologyroutefigure2ndchapterCitystatusanddevelopmentplanning2.1citybasicprofile2.1.12SubpartB-OrganizationandPersonnel§211.22Responsibilitiesofqualitycontrolunit.a)Thereshallbeaqualitycontrolunitthatshallha