最新医疗机构制剂配制监督管理办法.docx

医疗机构制剂配制监督管理方法
of rural drinking water sources, protection of drinking water sources in rural areas by the end urces in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
　　第六条　医疗机构配制制剂，必须具有能够保证制剂质量的人员、设施、检验仪器、卫生条件和管理制度。
　　第七条　医疗机构设立制剂室，应当向所在地省、自治区、直辖市〔食品〕药品监督管理部门提交以下材料：
　　〔一〕?医疗机构制剂许可证申请表?〔见附件1〕；
　　〔二〕实施?医疗机构制剂配制质量管理标准?自查报告；
　　〔三〕医疗机构的根本情况及?医疗机构执业许可证?副本复印件；
　　〔四〕所在地省、自治区、直辖市卫生行政部门的审核同意意见；
　　〔五〕拟办制剂室的根本情况,包括制剂室的投资规模、占地面积、周围环境、根底设施等条件说明，并提供医疗机构总平面布局图、制剂室总平面布局图〔标明空气洁净度等级〕；
　　制剂室负责人、药检室负责人、制剂质量管理组织负责人简历〔包括姓名、年龄、性别、学历、所学专业、职务、职称、原从事药学工作年限等〕及专业技术人员占制剂室工作人员的比例；
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
　　制剂室负责人、药检室负责人、制剂质量管理组织负责人应当为本单位在职专业人员，且制剂室负责人和药检室负责人不得互相兼任；
　　〔六〕拟配制剂型、配制能力、品种、规格；
　　〔七〕配制剂型的工艺流程图、质量标准〔或草案〕；
　　〔八〕主要配制设备、检测仪器目录；
　　〔九〕制剂配制管理、质量管理文件目录。
　　第八条　申请人应当对其申请材料的真实性负责。
　　第九条　省、自治区、直辖市〔食品〕药品监督管理部门收到申请后，应当根据以下情况分别作出处理：
　　〔一〕申请事项依法不属于本部