河北省GMP示范基地运行过程中存在的问题和对策

Problems and Countermeasures in the Operation of GMP Demonstration Bases in Hebei Province

目的:解决GMP示范基地运行过程中存在的问题,更好地发挥示范基地作用,为职业化、专业化药品检查员队伍的建设打下坚实基础,推进药品生产企业监管的科学化和专业化。方法:通过汇总历年来检查员实训的情况、统计示范基地的运行现状、召开专题研讨会等方式,分析示范基地运行过程中存在的主要问题,并提出相应的改进措施和办法。结果与结论:建议修订和完善示范基地管理的相关制度;加强课题研究的合作,建立定期沟通交流机制;科学调研实训需求,加强检查员实训的针对性,从而提升检查员的专业化水平,有力地贯彻落实“四个最严”的要求、履行药品监管职责、保障人民群众用药安全。

Objective:To solve the problems existing in the operation of GMP demonstration bases,make a better use of the demonstration bases,lay a solid foundation for the construction of the professional and specialized drug inspectors team,and promote the scientific and professional supervision of pharmaceutical manufacturers.Methods:Through summarizing the practical training of inspectors over the years,making statistics on the operation status of the demonstration bases and calling a symposium,the main problems in the operation process of the demonstration base were analyzed,and corresponding measures and methods were put forward.Results and Conclusion:It is suggested that the relevant systems of the management of the demonstration bases be revised and improved;research cooperation be strengthened and a mechanism for regular communication be established;the training needs be investigated scientifically,the pertinence of inspectors'practical training be strengthened;so as to improve the professional level of inspectors,effectively implement the"four most stringent"requirements,perform drug regulatory duties and ensure the safety of the people's medication.