广东省药品经营企业监督检查缺陷项目分析及改进建议  

Analysis and improvement suggestions for supervision and inspection deficiency items in pharmaceutical business enterprises in Guangdong Province

作　　者：符光量 江映珠 梁杰康 FU Guangliang;JIANG Yingzhu;LIANG Jiekang(Guangdong Provincial Drug Administration Evaluation and Certification Center,Guangzhou 510080,China)

机构地区：[1]广东省药品监督管理局审评认证中心,广州510080

出　　处：《中国处方药》2025年第7期24-29,共6页Journal of China Prescription Drug

摘　　要：目的为广东省药品经营企业[药品批发企业和药品零售连锁企业(总部)]的监督检查提供针对性的改进建议,以提高药品经营企业的质量管理水平。方法基于2023年广东省药品监督管理局对201家药品经营企业开展的异地交叉飞行监督检查数据,按照《药品检查管理办法(试行)》及相关法规要求,对检查结果进行统计分析,重点对缺陷项目进行汇总与高频次分析,剖析企业存在的主要问题,并提出相应的改进措施。结果监督检查发现严重缺陷项目19项次,占发现缺陷项目总数1.6%;发现主要缺陷项目482项次,占发现缺陷项目总数41.6%;发现一般缺陷项目658项次,占发现缺陷项目总数56.8%。结论药品经营企业应当提高质量管理意识,做好药品购销渠道和储运温度的管理,守住药品经营质量的“生命底线”,有效确保药品经营质量。Objective To provide targeted improvement suggestions for the supervision and inspection of pharmaceutical business enterprises[pharmaceutical wholesale enterprises and retail chain enterprises(headquarters)]in Guangdong Province,aiming to enhance the quality management level of these enterprises.Methods Based on the data from the cross-regional flight inspections conducted by the Guangdong Provincial Drug Administration in 2023 on 201 pharmaceutical business enterprises,the inspection results were statistically analyzed in accordance with the requirements of the Drug Inspection Management Measures(Trial)and related regulations.A focus was placed on summarizing and analyzing the frequency of deficiency items,identifying the main issues in enterprises,and proposing corresponding improvement measures.Results During the supervision and inspection,19 critical deficiency items were identified,accounting for 1.6%of the total deficiency items;482 major deficiency items were identified,accounting for 41.6%of the total;and 658 minor deficiency items were identified,accounting for 56.8%of the total.Conclusion Pharmaceutical business enterprises should enhance their quality management awareness,manage the purchase and sales channels of pharmaceuticals,and control storage and transportation temperatures to safeguard the"lifeline"of pharmaceutical business quality,thereby effectively ensuring the quality of pharmaceutical business operations.

关 键 词：药品经营企业 监督检查 缺陷项目 

分 类 号：R95[医药卫生—药学]