摘要
目的:通过分析山东省药品许可换证检查过程中发现的一些普遍性问题,为监管部门科学监管与企业持续提升质量管理体系提出建议与对策。方法:统计169家药品批发企业换证检查中发现的缺陷项目,并分析企业普遍存在的问题。结果:药品批发企业换证现场检查常见问题主要集中在质量管理体系文件、储存与养护、人员与培训、设施与设备方面。结论:监管部门应加强监督检查力度,做好日常监管,并加强法律法规的宣贯工作;企业在药品经营过程中,各岗位人员应全员参与,按照制度履行职责。通过提高企业全体员工的质量意识,促进企业规范经营和健康发展。
Objective:To provide suggestions and countermeasures for the scientific supervision of regulatory departments and continuous improvement of quality management system,by analyzing some common problems found in the process of pharmaceutical wholesale enterprises renewal inspection in Shandong Province.Methods:The defects found in the renewal inspection of 169 pharmaceutical wholesale enterprises were counted,and the common problems of enterprises were analyzed.Results:The common problems found in the process of pharmaceutical wholesale enterprises renewal inspection mainly focus on quality management system documents,storage and maintenance,personnel and training,and facilities and equipment.Conclusion:The supervision department should strengthen the supervision and inspection,do a good job in daily supervision,and strengthen the publicity and implementation of laws and regulations;in the process of drug distribution,all staff at all positions should participate in the process and perform their duties according to the system.By improving the quality consciousness of all employees,We will promote the standardized operation and healthy development of enterprises.
作者
尚京迎
谢纪珍
王群
杨成勇
Shang Jingying;Xie Jizhen;Wang Qun;Yang Chengyong(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)
出处
《中国药事》
CAS
2022年第12期1363-1368,共6页
Chinese Pharmaceutical Affairs
关键词
药品批发企业
换证检查
缺陷项目
现状分析
对策思考
pharmaceutical wholesale enterprises
renewal inspection
defective items
current situation analysis
countermeasures
