摘要
目的:以药品经营企业各类现场检查为样本,分析企业在数据与记录管理方面存在的各种问题,以期为药品监管部门精准高效监管、企业持续优化改进提供参考。方法:汇总笔者参加的126家次现场检查报告,结合工作实际,分析检查报告中关于数据与记录管理方面的缺陷项目,归纳常见问题,提出对策和建议。结果:现场检查报告中涉及数据与记录管理的缺陷项目累计429项,其中严重缺陷3项,主要缺陷194项,一般缺陷232项,从高频次缺陷项目分布特点来看,涉及温湿度自动监测系统和计算机系统两大系统方面的缺陷问题尤为典型,其中温湿度自动监测系统方面的问题表现为真实性存疑、重要数据缺失、准确性打折、可追溯不强、规范性管理不足等;计算机系统方面的问题表现为不准确、不完整、更新不及时、追溯困难、跨系统间数据交互受阻等。结论:企业在数据与记录管理方面存在的问题依然突出,药品监管部门、行业协会、企业等各方力量应同向发力,共同引导。药品监管部门应坚持监管与服务并重,通过政策引导与技术帮扶提升企业合规能力,依托药品监管大数据平台实现“非现场监测-动态预警-靶向核查”的多元化监管,并联合行业协会加强平台建设第三方的引导,对主观恶意行为实施零容忍监管震慑;企业应注重硬件与软件建设并重,通过现代化硬件设备的投入助力自动化管理,通过人员观念意识的改变增强主观能动性,通过风险管理工具的应用形成风险消除的全流程闭环管理。
Objective:To analyze various issues in data and records management of pharmaceutical business enterprises based on on-site inspections,and to provide references for precise and efficient supervision by drug regulatory authorities and continuous optimization and improvement of enterprises.Methods:A total of 126 on-site inspection reports involving pharmaceutical distribution enterprises were reviewed.Deficiency items related to data and records management were analyzed,summarized,and categorized based on practical work experience.Countermeasures and suggestions were proposed accordingly.Results:A total of 429 deficiency items related to data and records management were identified,including 3 critical deficiencies,194 major deficiencies,and 232 minor deficiencies.High-frequency deficiency items predominantly involved issues in two key systems:automatic temperature and humidity monitoring systems and computerized systems.The problems in the automatic temperature and humidity monitoring system were mainly manifested as questionable authenticity,missing important data,reduced accuracy,weak traceability,and insufficient standardized management.The problems in the computer system were mainly manifested as inaccuracy,incompleteness,untimely updates,difficult traceability,and blocked data interaction between systems.Conclusion:The problems in data and record management of enterprises are still prominent.Pharmaceutical regulatory authorities,industry associations,and enterprises should work together to guide and improve the situation.Pharmaceutical regulatory authorities should adhere to the combination of supervision and service,enhance the compliance ability of enterprises through policy guidance and technical support,and rely on the big data platform of pharmaceutical supervision to achieve diversified supervision of"non-on-site monitoring-dynamic early warning-targeted verification".They should also join hands with industry associations to strengthen the construction of the platform and guide the third parties,and implement zero-tolerance supervision and deterrence for intentional malicious behaviors.Enterprises should focus on both hardware and software construction,promote automated management through the investment in modern hardware equipment,enhance subjective initiative by changing the awareness of personnel,and form a full-process closed-loop management of risk elimination through the application of risk management tools.
作者
张磊
王敏刚
Zhang Lei;Wang Mingangg(Center for Drug Inspection of Fujian Province,Fuzhou 350003,China)
出处
《中国药事》
2025年第6期624-634,共11页
Chinese Pharmaceutical Affairs
关键词
数据与记录管理
药品经营企业
药品流通环节
现场检查
缺陷项目
data and records management
pharmaceutical distribution enterprises
pharmaceutical distribution process
on-site inspection
deficiency items
