[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fLxjaC2iMnN4k9EyiKyzLioTSOjdgtP9kmCA4wr4GWUc":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":12,"question":19,"related":20,"source":30,"type":31},[],"2024-06-15 21:02:57",151836258,[8,9,10,11],"质量管理部门","组织机构","质量控制系统","质量保证系统",{"count":13,"courseId":14,"courseImg":15,"courseName":16,"workId":17,"workName":18},57,"6a5a4041581a14ba9db93c8c7714e8ef","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002F5c5ae0ec6aa521c7261f76876d18ac64.png","药事管理与法规-2024春季学期","work_35705464","24总复习五","企业为保证系统有效运行,必须建立的是( )",[21,32,35,44,54,63,72,81,91,100],{"answer":22,"createTime":5,"id":23,"options":24,"question":29,"source":30,"type":31},[],151836257,[25,26,27,28],"每批产品应当检查产量和物料平衡, 确保物料平衡符合设定的限度","不得在同一生产操作间同时进行不同品种和规格药品的生产操作,除非没有发生混淆或交叉污染的可能","在生产的每一阶段,应当保护产品和物料免受微生物和其他污染","每次生产结束后应当进行清场,下次生产不必检查可直接进行生产","下列说法不正确的是( )","v1",0,{"answer":33,"createTime":5,"id":6,"options":34,"question":19,"source":30,"type":31},[],[8,9,10,11],{"answer":36,"createTime":5,"id":37,"options":38,"question":43,"source":30,"type":31},[],151836260,[39,40,41,42],"委托方","受托方","生产车间","检验人员","应当对受托生产或检验的全过程进行监督的是( )",{"answer":45,"createTime":46,"id":47,"options":48,"question":53,"source":30,"type":31},[],"2024-06-15 21:02:58",151836262,[49,50,51,52],"生产开始到生产结束的过程","研发到出售的过程","产品从最初的研发、上市直至退市的所有阶段","生产到出售","质量风险管理是采用前瞻或回顾的方式,对质量风险进行评估、控制、沟通、审核的系统过程,是在( )",{"answer":55,"createTime":46,"id":56,"options":57,"question":62,"source":30,"type":31},[],151836264,[58,59,60,61],"饮食习惯","健康","人员着装","卫生习惯","人员卫生操作规程内容不包括( )",{"answer":64,"createTime":46,"id":65,"options":66,"question":71,"source":30,"type":31},[],151836266,[67,68,69,70],"空气悬浮粒子数","温湿度","浮游菌","沉降菌","对洁净级别划分不起主要影响的参数是( )",{"answer":73,"createTime":46,"id":74,"options":75,"question":80,"source":30,"type":31},[],151836268,[76,77,78,79],"卡介苗","青霉素类","β-内酰胺类","维生素类","不需采用专用设施和设备生产的品种是( )",{"answer":82,"createTime":83,"id":84,"options":85,"question":90,"source":30,"type":31},[],"2024-06-15 21:02:59",151836270,[86,87,88,89],"设备经过改造","设备经过重大维修","操作人员更换","设备使用较长时间","不需要对设备进行再确认的是( )",{"answer":92,"createTime":83,"id":93,"options":94,"question":99,"source":30,"type":31},[],151836272,[95,96,97,98],"1年","2年","3年","4年","批生产记录应按批号归档,保存至药品有效期后( )",{"answer":101,"createTime":83,"id":102,"options":103,"question":108,"source":30,"type":31},[],151836275,[104,105,106,107],"至少1年","至少2年","至少3年","至少5年","根据现行版《药品经营质量管理规范》,药品批发企业记录及凭证保存的时限应当是( )"]