欧盟生产质量管理规范监管制度对我国药品生产企业的启示

Revelation of EU GMP Regulatory System to Pharmaceutical Manufacturers in China

目的提高我国药品生产企业(简称药企)欧盟生产质量管理规范(GMP)认证的合格率。方法通过检索EudraGMP数据库,分析中印两国药企接受欧盟GMP认证的现状,以及我国不合格药企存在的缺陷,从而提出对我国药企的启示。结果截至2019年12月31日,我国药企共接受欧盟GMP检查516次,不合格率为8.33%;印度药企共接受欧盟GMP检查783次,不合格率为4.98%。我国接受欧盟GMP检查的药企多为原料药生产企业,其中收到不合格声明的药企也多为这类企业,存在的缺陷主要集中于质量管理、污染、记录、设施设备等。结论我国药企应重视车间硬件设施建设、文件记录、产品风险评估及生产全过程质量控制,并大力推进制剂生产企业的国际化进程。

Objective To improve the qualification rate of European Union(EU)Good Manufacturing Practices(GMP)certification of Chinese pharmaceutical manufacturers.Methods By searching Eudra GMP database,the status of Chinese and Indian pharmaceutical manufacturers accepting the EU GMP certification was statistically analyzed,and the defects of China’s unqualified pharmaceutical manufacturers were analyzed,so as to provide a revelation for Chinese pharmaceutical manufacturers.Results As of December 31 st,2019,Chinese pharmaceutical manufacturers had accepted 516 times of EU GMP inspections,and the unqualified rate was 8.33%.Indian pharmaceutical manufacturers had accepted 783 times of EU GMP inspections,and the unqualified rate was 4.98%.Most of the pharmaceutical enterprises in China accepted the EU GMP inspection were active pharmaceutical ingredient(API)manufacturers,and most of the pharmaceutical manufacturers that received unqualified declarations were also API manufacturers.The defects were mainly concentrated in quality management,pollution,records,facilities and equipment,etc.Conclusion Chinese pharmaceutical manufacturers should pay attention to the construction of workshop hardware facilities,documentation,product risk assessment and quality control in the whole process of production,and should vigorously promote the internationalization of preparation manufacturers.