28家药品生产企业飞行检查和跟踪检查问题分析及监管对策
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篇名: 28家药品生产企业飞行检查和跟踪检查问题分析及监管对策
TITLE:
摘要: 目的:为药品生产企业完善《药品生产管理规范》(GMP)质量管理体系建设和药品监管部门提高监管水平提供参考。方法:通过对2018年2月6日-2019年1月25日国家药品监督管理局网站公布的药品飞行检查和药品跟踪检查通报的28家药品生产企业存在的问题进行分析总结,找出共性问题并对其进行原因分析,进而提出监管对策。结果与结论:药品生产企业自身存在一些GMP实施不到位的问题,例如部分关键岗位人员未能正确履职、相关人员培训效果不理想,实际生产工艺与批准的法定工艺不一致、物料管理不规范、批生产记录不完整、不能对药品生产全周期进行有效监控等问题;而监管部门也存在检查员现场检查的尺度差异较大、检查员的检查能力和水平有待加强、监管手段创新不足等问题。建议药品生产企业应完善企业GMP质量管理体系建设、加强企业相关人员的培训;建议监管部门继续推进企业的“放管服”改革工作,严格检查员准入条件,加强对检查员队伍的业务培训和思想建设,加强监管制度建设,重视监管手段创新,从而共同维护药品的安全有效和质量可控。
ABSTRACT: OBJECTIVE: To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS: Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th, 2018 to January 25th, 2019, the common problems were found and their causes were analyzed, then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS: Pharmaceutical enterprises have some problems of inadequate implementation of GMP, such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel, the inconsistency between actual production technology and approved legal technology, the non-standard management of enterprise materials, the incomplete batch production records and the inability to effectively monitor the production cycle. However, there are also some problems in the supervision department, such as the large difference in the scale of inspectors’ on-site inspection, the need to strengthen the inspectors’ inspection ability and level, and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel; the regulatory authorities should continue to promote the reform of “release, control and service”, strictly enforce the access conditions of inspectors, strengthen the training of inspectors and ideological construction of the inspector team,further strengthen the construction of supervision system and enhance the innovation of supervision means, so as to jointly maintain the safety, effectiveness and quality controllability of medicines.
期刊: 2019年第30卷第20期
作者: 陆仕华,韦莹莹,李杉,韦广辉
AUTHORS: LU Shihua,WEI Yingying,LI Shan,WEI Guanghui
关键字: 药品监管;药品生产管理规范;生产企业;对策
KEYWORDS: Drug supervision; GMP; Manufacturer; Countermeasures
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