关键词: 药品零售企业, 药品经营许可, 现场检查, 缺陷项目

Abstract: Objective： To provide reference for drug distribution license renewal on-site inspection of drug retail enterprises and standardize the operation of drug retail enterprises. Methods： The defective items found in 224 on-site inspection reports of drug retail enterprises in Xiamen city between 2020 and 2022 were counted， the common problems found in the on-site inspection of drug retail enterprises were analyzed， and the measures and suggestions were put forward. Results： The total occurrence frequency of defective items found during the on-site inspection was 1228， including 1 serious defective item， 105 main defective items and 1122 general defective items. The problems found in the inspection involving personnel management（36.24%）， sales management（16.69%）， document management（13.19%）， procurement and acceptance（10.75%）， display and storage（7.57%） and facility and equipment（7.33%）. Conclusion： Drug retail enterprises should improve quality management system in accordance with laws and regulations and their actual situations， strengthen personnel training management， facility and equipment management and management of the whole business process. Drug regulatory departments improve regulatory efficiency by increasing the inspection frequency， promoting smart regulation and enhancing the professional quality of inspectors， and urge drug retail enterprises to continue to meet the legal requirements throughout the whole process of operation.

Key words: Drug retail enterprises, Drug distribution license, On-site inspection, Defective items