山东省药品经营企业记录与数据管理缺陷问题分析及监管建议

Analysis and Supervison Suggestions on the Problems of Records and Data Management in Drug Distributors in Shandong Province

药品安全关系公众的生命健康,药品经营过程中的数据对药品流通质量安全和可追溯具有重要意义。笔者对2023年所在单位承担的255家次监督检查任务中发现的药品经营企业记录与数据管理方面存在的缺陷进行了归类分析,以期客观真实地反映药品经营企业在合规性方面存在的问题。同时,结合日常检查工作实际对出现缺陷问题的原因进行分析,为相关企业提升质量管理水平提供参考,为药品监管部门提升监管能力提出建议。

Drug safety is vital for public health,and the data generated during the drug management process holds significant importance for the safety and traceability of drug circulation.This article classifies and analyzes defects in the record and data management of pharmaceutical trading enterprises discovered during 255 supervision and inspection tasks undertaken by our unit in 2023.The aim is to objectively and accurately reflect the compliance issues existing in these enterprises.By analyzing the reasons behind the identified defects in daily inspection work,we provide references for enterprises to improve their quality management,and offer suggestions for drug regulatory authorities to improve their regulatory capabilities.