摘要
目的:分析我国GMP认证现状,思考GMP认证专职检查员队伍建设的对策,为国家相关部门提供参考。方法:通过对比国内外药品GMP认证现状和检查员的管理模式,从战略规划、制度建设、推进信息化、构建高效组织机构等4个层面提出建议。结果与结论:建立健全涉及人事、财务、培训、考核、监督、保密等方面的制度,形成高效的组织机构,运用互联网实现信息化,是GMP专职检查员队伍建设改革的突破口,是建设一支重视创新、充满活力,能够持续改进的学习型检查员队伍的重要对策。
Objective： To analyze the present situation of Chinese GMP certification, and study GMP certification countermeasures for the construction of full-time inspector team, so as to provide references for the related department. Methods： By comparing the current situation the domestic and foreign drug GMP certification and the management model of the inspector, suggestions were put forward from the four aspects of strategic planning, system construction, promotion of information technology, and construction of efficient organization. Results And Conclusion： Establishing and improving the system related to personnel, financial, training, appraisal, supervision and security and other is the key to form effective organization; Using the Internet to promote information technology is the breakthrough of GMP full-time inspector team construction reform, and also the important strategy to build a new type of inspector team with innovation, full of vitality, and willing to continuously improve themselves.
出处
《中国药事》
CAS
2016年第8期756-761,共6页
Chinese Pharmaceutical Affairs
关键词
GMP
专职检查员
建设模式
FDA
信息化
GMP
professional inspector
construction mode
FDA
informationization
