摘要
目的为药品生产企业的GMP生产管理提供参考。方法对2017、2018两年来国家药品监督管理局通报的飞行检查中发现的制药企业缺陷情况进行分析。结果两年间通报的企业一共为66家次,缺陷涉及GMP章节一共为261项次,其中涉及质量控制与质量保证、物料与产品、生产管理、文件管理、质量管理、机构与人员章节的比例为74.33%。结论企业需要重点从加强主要负责人对GMP精髓的理解、建立与企业相适应的质量管理体系、定期与不定期的对质量体系进行检查、建设有效的培训体系着手,才能建设起良好的药品生产管理体系。
Objective To provide reference for GMP production management of pharmaceutical manufacturers.Methods Analysis of the defects of pharmaceutical companies found in the unannounced inspection notified by the National Medical Products Administration in 2017 and 2018.Results A total of 66 companies were notified in two years,and the GMP chapter involved in the defect was 261 items,including the proportion of quality control and quality assurance,materials and products,production management,document management,quality management,and organization and personnel.It is 74.33%.Conclusion Pharmaceutical companies need to focus on strengthening the understanding of the GMP essence of the main responsible person,establishing a quality management system that is compatible with the companies,checking the quality system regularly and irregularly,and building an effective training system.Only by doing this,GMP system can be effectively established.
作者
赵余
陈丹镝
黄琴
ZHAO Yu;CHEN Dan-di;HUANG Qin(West China School of Public Health and West China Fourth Hospital,Sichuan University,Chengdu,Sichuan 610041,China)
出处
《现代预防医学》
CAS
北大核心
2020年第6期1048-1051,共4页
Modern Preventive Medicine
关键词
飞行检查
缺陷
GMP
Unannounced inspection
Defects
GMP
作者简介
赵余(1990-),男,在读硕士,研究方向:医药卫生政策与监管;通讯作者:陈丹镝,E-mail:dandic@qq.com。
