对药品生产企业实施GMP的调查与思考

Investigation and Consideration on Implementation of GMP in Pharmaceutical Production Enterprises

目的探索药品生产企业深入贯彻药品GMP,确保生产环节药品质量。方法通过调查,归纳分析当前药品生产企业实施GMP管理中存在的主要问题并提出建议。结果与结论药品生产企业深入贯彻GMP,应进一步解放思想,实现五个转变、做到五个结合、文件修订把握四个基本点、实现文件的八个特性,把GMP的本质要求量化、细化到每一个药品的管理和生产全过程。同时药监部门也要实事求是地解决药品GMP认证现场检查中存在的问题。

Objective Explore the implementation of GMP in pharmaceutical production Enterprises to ensure the quality of medicines.Methods Through investigation on implementation of GMP in pharmaceutical production enterprises,analyzed the existing problems and the causes of problems.Results and Conclusion We must further reform our concept about GMP,guide enterprises to establish a series of new concept,realizing five conversions,and five combination,document revision to grasp four basic points,eight characteristics,clarify the essential requirements of GMP to each drug management and production process.Drug agencies should realistically resolve serious problems in the spot checks.