文章摘要
赵艳梅,韩昆,董敏,由春娜.完善制药企业药品研发质量管理体系的探讨[J].中国药事,2019,33(8):896-903
完善制药企业药品研发质量管理体系的探讨
Discussion on Improving the Quality Management System of Drug Research and Development in Pharmaceutical Enterprises
投稿时间:2019-03-29  
DOI:10.16153/j.1002-7777.2019.08.009
中文关键词: 制药企业  药品研发  质量管理体系
英文关键词: pharmaceutical enterprise  drug R&D;quality management system
基金项目:
作者单位E-mail
赵艳梅 烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心、分子药理和药物评价教育部重点实验室, 烟台 264005  
韩昆 绿叶制药集团有限公司, 烟台 264003  
董敏 绿叶制药集团有限公司, 烟台 264003  
由春娜 烟台大学新型制剂与生物技术药物研究山东省高校协同创新中心、分子药理和药物评价教育部重点实验室, 烟台 264005 youchunna@luye.com 
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中文摘要:
      目的:为我国制药企业药品研发质量管理体系的建立和完善提供建议与思考。方法:通过分析我国和美国FDA药品监管机构的检查报告、访谈我国制药企业研发质量管理负责人,了解我国制药企业研发质量管理的现状,为药物研发质量管理体系的建立和完善提供建议。结果与结论:完善的药品研发质量管理体系应包括以下几点:①设立独立的研发质量管理部门并充分赋权;②分类建立文件体系,使质量管理有章可循;③加强培训,确保培训效果;④建立有效的质量考核管理制度,确保质量体系有效运行。
英文摘要:
      Objective:To provide suggestions and thoughts for the establishment and improvement of the quality management system for drug research and development (R&D)in pharmaceutical enterprises in China. Methods:Inspection reports of drug regulatory agencies from FDA and China were analyzed, persons in charge of R&D quality management were interviewed to understand the current status of quality management of R&D in pharmaceutical enterprises in China and provide suggestions for the establishment and improvement of the quality management system for R&D. Results and Conclusion:A perfect quality management system for drug R&D should include the following aspects:① to establish an independent R&D quality management department and fully empower it; ② to establish a document system to ensure that quality management has a rule to follow; ③ to strengthen training and ensure the effectiveness of training; ④ to establish an effective quality assessment system to ensure the effective operation of the quality system.
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