加强医疗机构制剂生产人员培训的实践与思考  

On the Practice of Strengthening Training of the Personnel of Preparation Production in Medical Institutions

作　　者：倪晓霞[1] 王庆芬[1] 陈锦珊[1] Ni Xiaoxia;Wang Qingfen;Chen Jinshan(75th Hospital of PLA / Affiliated Southeast Hospital of Xiamen University,Zhangzhou 363000,China)

机构地区：[1]解放军175医院厦门大学附属东南医院,漳州363000

出　　处：《中国药事》2018年第10期1419-1422,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨加强医疗机构制剂生产及管理人员培训的必要性,总结经验,思考改进措施。方法:从法规要求、制剂质量安全、创新发展3方面,讨论加强人员培训的必要性;并从培训组织架构、培训制度与方式、重点内容与培训实效等方面进行总结;从人员思想、培训质量及考核奖惩等方面持续改进。结果与结论:医疗机构制剂生产、质量管理相关人员的培训工作,是GMP检查和医疗机构制剂许可证验收的关键指标,必须引起医疗机构制剂单位的重视,加强投入,保证培训取得实效,保证制剂质量。Objective： To investigate the necessity of strengthening training of personnel engaged in preparation production and management in medical institutions, to sum up experience and to suggest measures for improvement. Methods： Firstly, the necessity for strengthening training of personnel was analyzed from three aspects： regulatory requirements, quality and safety of preparations, innovation and development. Secondly, the experience and practice were summed up from training organization, training regulation and mode, key contents and training effectiveness. Finally, the work could be continuously improved from personnel thoughts, training quality and assessment of reward or punishment, etc. Results and Conclusion： The training of personnel engaged in preparation production and quality management in medical institutions was the key index for GMP inspection and the acceptance of Pharmaceutical Preparation Certificate for Medical Institutions, which should be paid more attention to by medical institutions so as to strengthen investment to guarantee the effectiveness of personnel training and ensure the quality of preparations.

关 键 词：医疗机构 制剂生产 质量管理 人员培训 GMP检查 

分 类 号：R95[医药卫生—药学]