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目的分析自新版GSP认证以来,广州市药品零售企业GSP认证跟踪检查结果的情况,指出药品零售企业在日常经营过程中经常出现的质量管理问题,提出相应建议,进一步规范药品零售企业实施GSP,提高GSP检查员的能力。方法分析2015~2016年2 848份广州市药品零售企业GSP认证跟踪检查结果,采用计量学方法进行分类统计。结果质量管理与职责方面出现缺陷项目17次;人员管理方面出现缺陷项目871次;文件管理方面出现缺陷项目214次;设施与设备方面出现缺陷项目419次;采购与验收方面出现缺陷项目480次;陈列与储存方面出现缺陷项目701次;销售管理方面出现缺陷项目504次;售后管理方面出现缺陷项目57次。结论通过对缺陷项目的分类统计,分析企业在日常经营过程中存在的具体问题及原因,以保障药品质量安全为主线,以规范药品市场秩序及保障人民群众用药安全为目的,加强对药品零售企业监督检查力度,进一步提升药品安全监管水平。
OBJECTIVE: To analyze the GSP certification follow-up inspection results of pharmaceutical retailers in Guangzhou since the GSP certification and to point out the quality management problems that pharmaceutical retailers often face in their daily operations and put forward corresponding suggestions to further standardize the implementation of GSP by pharmaceutical retailers GSP Inspector’s ability. Methods A total of 2848 Guangzhou GSP certification follow-up examinations were conducted from 2015 to 2016, and the classification statistics were calculated by using the method of metrology. Results 17 defects in quality management and responsibility; 871 defects in personnel management; 214 defects in document management; 419 defects in facilities and equipment; 480 defects in procurement and inspection; 701 defective items in display and storage; 504 defective items in sales management; and 57 defective items in after-sales management. Conclusion According to the classification and statistics of the defective items, the specific problems and reasons existed in the daily operation of the enterprises are analyzed. The main line is to ensure the quality and safety of the drugs, and to standardize the market order of the pharmaceutical products and ensure the safety of drug users, Supervision and inspection efforts to further enhance the level of drug safety supervision.