[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fUYR_jYsX6DodWj9O0Q9deH_0uN-Pz_uOdJJHJXtnF_E":3},{"answer":4,"createTime":5,"id":6,"options":7,"origin":12,"question":19,"related":20,"source":31,"type":32},[],"2025-06-17 10:45:07",202463846,[8,9,10,11],"营业执照","药品生产许可证","炮制规范","药品经营许可证",{"count":13,"courseId":14,"courseImg":15,"courseName":16,"workId":17,"workName":18},31,"53e1d2ef4961cca8eea3e23969ad2cb9","https:\u002F\u002Ftihai-oss-cloud.itihey.com\u002Fimg\u002F03a579384a6dc297c89809b582fcc767.png","默认课程","exam_159770308","节后测试","药品生产企业在工商行政管理部门登记注册的证明是( )",[21,33,42,53,62,65,74,83,92,102],{"answer":22,"createTime":23,"id":24,"options":25,"question":30,"source":31,"type":32},[],"2025-06-17 10:45:05",202463722,[26,27,28,29],"具有至少三年从事药品生产和质量管理的实践经验,从事过药品生产过程控制工作","具有至少五年从事药品生产和质量管理的实践经验,从事过药品生产过程控制工作","具有至少五年从事药品生产和质量管理的实践经验,从事过药品生产过程控制和质量检验工作","具有至少三年从事药品生产和质量管理的实践经验,从事过药品生产过程控制和质量检验工作","下列符合质量受权人任职条件的是( )","v1",0,{"answer":34,"createTime":23,"id":35,"options":36,"question":41,"source":31,"type":32},[],202463755,[37,38,39,40],"上交药品行政管理部门","退还药品经销商","销毁","返包","因质量原因退货和收回的药品,应当( ),有证据证明退货产品质量未受影响的除外",{"answer":43,"createTime":44,"id":45,"options":46,"question":52,"source":31,"type":32},[],"2025-06-17 10:45:06",202463803,[47,48,49,50,51],"不少于3个月一次","不少于12个月一次","不少于6个月一次","不少于18个月一次","不少于24 个月一次","一般来说,和生产相关的关键仪表校准间隔应该为( )",{"answer":54,"createTime":44,"id":55,"options":56,"question":61,"source":31,"type":32},[],202463821,[57,58,59,60],"经批准用来指导药品生产活动的通用性文件","一切涉及生产、经营管理的书面标准和实施标准的结果","规范书面内容的文字材料","一般是指由法定机关、单位印发,用来处理公务活动,并具有特定格式的书面文字材料","标准操作规程是( )",{"answer":63,"createTime":5,"id":6,"options":64,"question":19,"source":31,"type":32},[],[8,9,10,11],{"answer":66,"createTime":5,"id":67,"options":68,"question":73,"source":31,"type":32},[],202463864,[69,70,71,72],"中药饮片","有机合成","生物原料","辅料原料","企业原料药生产不包括( )",{"answer":75,"createTime":5,"id":76,"options":77,"question":82,"source":31,"type":32},[],202463879,[78,79,80,81],"质量监督","质量保证和质量控制","质量管理和药品检验","质量保证或质量控制","药品生产企业应当设立独立的质量管理部门,履行( ) 的职责",{"answer":84,"createTime":5,"id":85,"options":86,"question":91,"source":31,"type":32},[],202463905,[87,88,89,90],"视频","书面","电话","现场","药品生产委托方应当对受托方进行评估,对受托方的条件、技术水平、质量管理情况进行( )考核,确认其具有完成受托工作的能力,并能保证符合GMP的要求",{"answer":93,"createTime":94,"id":95,"options":96,"question":101,"source":31,"type":32},[],"2025-06-17 10:45:08",202463923,[97,98,99,100],"行政负责人","质检部门负责人","生产部门负责人","企业负责人","药品生产企业的质量管理部门应当受( )直接领导.( )",{"answer":103,"createTime":94,"id":104,"options":105,"question":110,"source":31,"type":32},[],202463943,[106,107,108,109],"温度18~26℃,相对湿度 45%~65%","温度20~24℃,相对湿度40%~60%","温度18~24℃,相对湿度45%~65%","温度18~24℃,相对湿度50%~70%","无特殊要求时,洁净区(室)的温湿度应控制在( )( )"]