国内外制药企业质量管理成熟度现状及对我国药品生产监管的启示

Current Situation of Quality Management Maturity of Domestic and International Drug Manufacturers and Its Implications for Drug Production Supervision

随着我国药品监管机制的日益成熟,国内制药企业的质量体系建设日趋健全,但质量管理成熟度与头部跨国制药企业相比仍有差距。本研究通过梳理美国食品药品管理局(FDA)质量量度项目、质量管理成熟度项目的实施内容,调研跨国制药企业质量管理成熟度现状,比照剖析了我国制药企业在质量管理过程中药品质量管理成熟度的现状,总结了质量绩效指标策略、质量体系运行有效性、持续改进质量文化建设等三个方面存在的问题,并提出了通过转变药品生产监管理念、加强质量管理成熟度研究、借助数字化手段赋能我国制药企业质量管理成熟度提升的建议。

With the increasing maturity of domestic drug supervision mechanism,the quality management system of domestic drug manufacturers is also becoming more well-established,but there is still a gap between domestic and top multinational drug manufacturers on quality management maturity.Through the review of the FDA quality metrics&quality management maturity program and the status survey of the quality management maturity of multinational drug manufacturers,this paper comparatively analyzed the situation of quality management maturity of domestic drug manufactures,and summarize the problem existing in the quality management of domestic enterprises from the aspects of quality performance indicator strategy,effectiveness of quality system operation,and continuous improvement quality culture,and it is proposed that by transforming the mindset of drug production supervision,strengthening the research on quality management maturity,and using digital means to empower the improvement of quality management maturity of domestic drug manufacturers.