| 何羡霞,姜志辉,李健,张强.基于药品监管的广州市医疗器械第三方物流常见问题分析[J].中国药事,2022,36(8):887-893 |
| 基于药品监管的广州市医疗器械第三方物流常见问题分析 |
| Analysis on Common Problems of Third-party Logistics Companies for Medical Equipment in Guangzhou |
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| DOI：10.16153/j.1002-7777.2022.08.006 |
| 中文关键词: 医疗器械 经营企业 第三方物流 现场检查 常见问题 |
| 英文关键词: medical devices enterprise third-party logistics on-site inspection common problems |
| 基金项目:广州市科技计划项目(编号 201509010012) |
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| 摘要点击次数: 665 |
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| 中文摘要: |
| 目的：通过对广州市22家医疗器械第三方物流企业的检查结果进行分析，指出第三方物流企业的优缺点，推进第三方物流企业更加规范发展。方法：以《广东省食品药品监督管理局医疗器械经营企业提供贮存、配送服务技术规定》为依据，对广州市医疗器械22家第三方物流企业的现场检查结果进行分类统计分析。结果：机构与人员方面出现缺陷项目29次；设施设备方面出现缺陷项目62次；计算机信息管理系统方面出现缺陷项目18次；质量管理制度及记录方面出现缺陷项目6次。结论：通过汇总广州市医疗器械第三方物流企业在检查过程中的常见问题，对企业提出针对性的建议，以供监管部门和物流企业相关人员进行参考。 |
| 英文摘要: |
| Objective: Through the analysis of the inspection results of 22 third-party logistics companies for medical equipment in Guangzhou, the advantages and disadvantages of third-party logistics companies were pointed out, and the more standardized development of third-party logistics companies was promoted. Methods: Based on the "Technical Regulations on the Provision of Storage and Distribution Services by Medical Device Operating Enterprises of Guangdong Food and Drug Administration", the on-site inspection results of 22 thirdparty logistics companies for medical devices in Guangzhou were classifi ed and analyzed. Results: There were 29 defective items in the organization and personnel, 62 defective items in the facilities and equipment, 18 defectiveitems in the computer information management system, and 6 defective items in the quality management system and records. Conclusion: By summarizing the common problems in the inspection process of third-party logistics companies for medical devices in Guangzhou, targeted suggestions for the companies were provided, so as to provide references for supervisory departments and relevant personnel of logistics companies. |
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