青海省医疗机构制剂室现场检查缺陷分析及对策研究  

Analysis of On-Site Inspection Defects and Countermeasures for the Preparation Room of Medical Institutions in Qinghai Province

作　　者：王永晶 刘学良 韩达斌 石春兰 问静 祁彦凯 汪永明 刘海青 WANG Yongjing;LIU Xueliang;HAN Dabin;SHI Chunlan;WEN Jing;QI Yankai;WANG Yongming;LIU Haiqing(Qinghai Center for Drug Evaluation and Inspection,Qinghai Xining 810007,China)

机构地区：[1]青海省药品审评核查中心,青海西宁810007

出　　处：《中国医药导刊》2024年第7期655-659,共5页Chinese Journal of Medicinal Guide

基　　金：青海省基础研究计划软科学项目(2023-ZJ-604)。

摘　　要：目的:为青海省医疗机构制剂室发展提供对策及建议,进一步规范医疗机构制剂室生产行为。方法:通过近年开展的全省医疗机构制剂室行政许可检查及常规检查,对32家医疗机构制剂室现场检查过程中发现的质量保证及质量控制方面存在的缺陷问题进行统计分析。结果:大部分医疗机构制剂室在人员与机构、房屋与设施、设备、物料等方面均存在不同程度的问题,医疗机构制剂配制管理有待进一步规范。结论:建议政府相关部门加大对各医疗机构制剂室的政策扶持,推动医疗机构制剂室发展,同时利用医院制剂优势资源,引导制剂室走向集中化,成立区域制剂中心,走集中化、特色化发展道路;建议各医疗机构制剂室加强队伍建设、加强人员培训、加强生产过程管理,进一步提高“人、机、料、法、环”各方面的管理水平,确保制剂质量安全、可控。Objective:to provide countermeasures and suggestions for the development of preparation rooms of medical institutions in Qinghai province,and further standardize the production behavior of preparation rooms of medical institutions.Methods:Through the administrative licensing inspection and routine inspection of preparation rooms in medical institutions in recent years,the defects in qual⁃ity assurance and quality control found in the on-site inspection of preparation rooms in 32 medical institutions were statistically analyzed.Results:There are some problems in personnel and institutions,building and facilities,equipment and materials to varying degrees,in the preparation rooms of medical institutions,and the management of medicinal preparations in medical institutions needs to be further standardized.Conclusion:It is suggested that the relevant government departments should increase policy support for the preparation rooms of medical institutions,promote the development of the preparation rooms of medical institutions,and at the same time,make use of the superior resources of hospital preparations to guide the preparation rooms to be centralized,set up regional preparation centers,and take the road of centralized and characteristic development.It is suggested that the preparation rooms of medical institutions should strengthen team building,personnel training and production process management,and further improve the management level of"people,machines,materials,methods and environment"to ensure the safety and controllability of preparation quality.

关 键 词：医疗机构制剂室 现场检查 缺陷 质量保证 质量控制 

分 类 号：R95[医药卫生—药学]