中国药业2025，Vol.34Issue(18)：19-23,5.DOI:10.3969/j.issn.1006-4931.2025.18.005
1件药品质量纠纷案对药品质量管理的启示与建议
Revelations and Recommendations on Pharmaceutical Quality Management from Pharmaceutical Quality Dispute Case
元潇 1史宇航 1杨伟怡 1高菲 1刘雪莹 1梁毅1
作者信息
- 1. 中国药科大学国际医药商学院,江苏 南京 211198
- 折叠
摘要
Abstract
Objective To explore the necessity of total quality management in pharmaceutical production.Methods The case analysis method was used,an administrative litigation case regarding the potency dispute of batroxobin concentrated solution was taken as an example to analyze quality management deficiencies in pharmaceutical production and testing processes,and improvement suggestions were proposed.Results and Conclusion Based on the Drug Administration Law and the Good Manufacturing Practice for Drugs,the disputed batch of products can be deemed non-comformity.Current pharmaceutical manufacturers over-rely on finished-product testing standards while neglecting process quality control,increasing pharmaceutical quality risks.Simultaneously,pharmaceutical purchasers lack sufficient understanding of quality standards,and regulatory systems exhibit blind spots in supervising production processes.It is recommended that pharmaceutical manufacturers implement total quality management and strengthen production process control;purchasing enterprises improve their quality evaluation systems;and regulatory authorities establish a comprehensive whole-process quality supervision mechanism with enhanced production oversight,so as to holistically improve pharmaceutical quality.关键词
药品生产/质量管理/质量纠纷/案例分析法Key words
pharmaceutical manufacturing/total quality management/quality dispute/case analysis分类
医药卫生引用本文复制引用
元潇,史宇航,杨伟怡,高菲,刘雪莹,梁毅..1件药品质量纠纷案对药品质量管理的启示与建议[J].中国药业,2025,34(18):19-23,5.
