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药品远程检查工作的方法建立与应用成效的探讨

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目的 探索建立药品远程非现场检查模式,为在疫情管控等特殊时期推广开展药品远程检查工作提供参考经验与作法.方法 建立药品远程检查工作流程,合理采用"远程检查"和"远程+现场检查"两种方式,借助现代通信科技,结合"互联网+"技术在"线上"+"线下"同步开展药品远程检查实践工作.结果 通过对持有人不同申请事项的技术审查和实施远程检查的风险评估,采用适宜的检查方式能有效开展并完成相应的检查任务,并获取检查双方均能接受和满意的效果.结论 药品远程检查工作流程的建立,弥补了检查人员在社会封控管理等特殊时期不能抵达现场开展药品监管检查工作的不足,是药品日常监管检查方式的一种有效补充.
Discussion on the Establishment and Application Effectiveness of Remote Inspection Methods for Drugs
OBJECTIVE Explore the establishment of remote drug inspection mode to provide new guidance on remote inspection in special periods such as epidemic control.METHODS Establish the working process of remote drug inspection,rationally adopt the two methods of"remote inspection"and"remote+on-site inspection",and carry out the practice of remote drug inspection"online"and"offline"simultaneously with the help of modern communi-cation technology and"Internet+"technology.RESULTS Through the technical examination of different applica-tion items and the risk assessment of remote inspection,the appropriate inspection method can effectively carry out and complete the corresponding inspection tasks,and obtain the results acceptable and satisfactory to both par-ties.CONCLUSION The establishment of remote drug inspection workflow is an alternative approach to the routine drug supervision and inspection.It will complement existing tools when inspectors cannot arrive at the site to carry out drug supervision and inspection in special periods such as social containment and control management.

Drug inspectionRemote inspectionWork establishment and effectiveness

王鼎峰、吴春敏、陈航、何沁雪

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福建省药品审核查验中心,福建福州 350003

药品远程检查 工作建立 检查成效

福建省药品监督管理局科技项目

2022003

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(1)
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