医疗机构制剂生产的风险因素分析与管控  

Analysis and Control of Risk Factors in Preparation Production of Medical Institutions

作　　者：曹国颖[1] 胡欣[1] 孙钊[1] 刘建中[1] 刘凤琴[1] 徐巧玲[2] 

机构地区：[1]北京医院,国家老年医学研究中心,药物临床风险与个体化用药评价北京市重点实验室,北京100730 [2]中国人民解放军第305医院,北京100017

出　　处：《中国药事》2018年第1期30-33,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:分析医疗机构制剂生产的风险因素。方法:汇总物料、设备与设施、生产过程、质量控制和员工的职业风险方面的风险点,具体阐述分析。结果与结论:通过完善软硬件建设、加强制剂风险的控制以及持续改进,保障产品质量和患者用药安全。Objective：To analyze the risk factors in preparation production of medical institutions.Methods：The risk factors of the materials,equipment and facilities,production process,quality control and occupational risk of employees were summarized and analyzed in detail.Results and Conclusion：Quality of preparation and medication safety of patients will be ensured by improving software and hardware,strengthening and continuously improving the control of risk factors.

关 键 词：医疗机构制剂 风险管控 持续改进 

分 类 号：R197.3[医药卫生—卫生事业管理]