药品审评检查机构质量管理体系建设实践探索  

Practical Research on the Construction of Quality Management System in Drug Review and Inspection Institutions

作　　者：柏建学 苏青 聂娇龙 黄传海 Bai Jianxue;Su Qing;Nie Jiaolong;Huang Chuanhai(Shandong Center for Food and Drug Evaluation&Certification,Jinan 250014,China)

机构地区：[1]山东省食品药品审评认证中心,济南250014

出　　处：《中国药事》2020年第4期412-416,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。Objective:To implement the work plan of the State Council to strengthen quality management and implement the national drug regulatory department to improve its own quality management system,review the construction situation of the quality management system of drug review and inspection institutions in Shandong Province to summarize experience and find out deficiencies in order to strengthen the quality management of review and inspection.Methods:The practical significance of introducing quality management system into drug review and inspection institutions was investigated.The practical experience of the construction of quality management system in drug review and inspection institutions in Shandong province was analyzed.The existing problems were considered.Results:The effective quality management system has played a positive role in promoting the standardization construction of drug review and inspection institutions and the development of drug review and inspection.Conclusion:Promoting the construction of quality management system in drug review and inspection institutions plays an important role and is also an inevitable requirement in standardizing its own construction,improving work quality,reducing business risks,and serving the development of the pharmaceutical industry.The quality management system of drug review and inspection institutions needs to be continuously improved to gradually meet international standards.

关 键 词：药品 审评 检查 质量管理体系 ISO 9001 

分 类 号：R95[医药卫生—药学]