新疆医疗机构制剂配制质量管理规范检查缺陷分析及建议  

Defects Analysis and Suggestions of Preparation Quality Management Standard for Reagent Prepared in Xinjiang Medical Institution

作　　者：马小华 舍莉萍 朱丽娜 任佳 李颖 MA Xiao-hua;SHE Li-pin;ZHU Li-na;REN Jia;LI Ying(Xinjiang Uygur Autonomous Region Drug Evaluation and Inspection Centre,Uygur 830002,China)

机构地区：[1]新疆维吾尔自治区药品审评查验中心,新疆乌鲁木齐830002

出　　处：《海峡药学》2022年第2期202-204,共3页Strait Pharmaceutical Journal

摘　　要：目的探讨新疆医疗机构制剂配制质量管理规范检查缺陷项目的分布特点,为加强医疗机构制剂配制质量管理提供监管思路。方法在对新疆医疗机构制剂室地域分布和配制剂型分析的基础上,汇总分析2019年开展的医疗机构制剂配制质量管理规范现场检查的缺陷项目。结果新疆医疗机构制剂室在人员培训、设施设备、物料管理、配制管理和质量控制管理等方面存在较多缺陷。结论药品监管部门应通过加强关键岗位人员培训、开展缺陷项目整改复查、坚决贯彻制剂处方工艺备案制度和创建检查结果反馈机制等措施,全面保障公众用药安全和合法权益。OBJECTIVE To explore the distribution characteristics of defective items of inspection of Pharmaceutical preparation in Good Preparation Quality Management Standard in Xinjiang medical Institutions,To strengthen the quality management of preparation in medical institutions.METHODS On the basis of the regional distribution and formulation dosage form analysis of the preparation room of Xinjiang medical institutions,the on-site inspection of the defects of the preparation quality management norms of medical institutions carried out in 2019 were summarized and analyzed.RESULTS So many defects in personnel training,facilities and equipment,material management,preparation management and quality control management was found in Xinjiang medical institutions.CONCLUSION The drug regulatory authorities comprehensively safeguard the safety and legitimate rights and interests of the public in drug use by strengthening the training of personnel in key positions,carrying out rectification and review of defective projects,resolutely implementing the system of filing preparation prescription processes and creating a feedback mechanism for inspection results.

关 键 词：医疗机构制剂 配制质量管理规范 缺陷项目 监管 

分 类 号：R95[医药卫生—药学]