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Analysis of defective items in supervision and inspection of drug modern logistics enterprises in Shandong Province
ZHANG Jiao, SHANG Jingying, ZHUANG Hui, WANG Qun, SONG Guangsheng
Shanghai Medical & Pharmaceutical Journal ›› 2023, Vol. 44 ›› Issue (19) : 106-110.
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Analysis of defective items in supervision and inspection of drug modern logistics enterprises in Shandong Province
({{custom_author.role_en}}), {{javascript:window.custom_author_en_index++;}}Objective: By analyzing the problems found in the process of market supervision and inspection of drug modern logistics enterprises in Shandong province, corresponding initiative suggestions are put forward to provide reference for the drug regulatory authorities to carry out inspections and assistance for enterprises to standardize their development. Methods: The defective items found in the 88 market surveillance inspections in Shandong Province carried out and implemented from May 2020 to July 2022 were counted and the main problems in GSP quality management system of drug modern logistics enterprises were analyzed. Results & Conclusion: Many problems were found in storage and maintenance, quality management system documents, facilities and equipment, personnel and training, receipt and acceptance, institutions and quality management responsibilities, and enterprises should give full play to the role of quality management department, improve the awareness of full participation in quality management, and continuously optimize the quality management system so as to achieve long-term and high-quality development.
GSP / modern pharmaceutical logistics / defect item {{custom_keyword}} /
表1 缺陷项目分布情况 |
| 缺陷类别 | 严重缺项（n） | 主要缺陷（n） | 一般缺陷（n） | 缺陷项目总数（n） | 占比/% |
|---|---|---|---|---|---|
| 储存与养护 | 0 | 35 | 59 | 94 | 17.90 |
| 质量管理体系文件 | 0 | 13 | 73 | 86 | 16.38 |
| 设施与设备 | 0 | 16 | 54 | 70 | 13.33 |
| 人员与培训 | 0 | 15 | 46 | 61 | 11.62 |
| 收货与验收 | 0 | 7 | 43 | 50 | 9.52 |
| 机构和质量管理职责 | 0 | 9 | 32 | 41 | 7.81 |
| 质量管理体系 | 0 | 14 | 12 | 26 | 4.95 |
| 运输与配送 | 0 | 4 | 20 | 24 | 4.57 |
| 校准与验证 | 0 | 14 | 7 | 21 | 4.00 |
| 采购 | 0 | 1 | 15 | 16 | 3.08 |
| 出库 | 0 | 4 | 8 | 12 | 2.29 |
| 计算机系统 | 0 | 10 | 1 | 11 | 2.10 |
| 售后管理 | 0 | 0 | 10 | 10 | 1.90 |
| 总则 | 2 | 0 | 0 | 2 | 0.38 |
| 销售 | 0 | 1 | 0 | 1 | 0.19 |
| 合计 | 2 | 143 | 380 | 525 | 100.00 |
表2 6大缺陷类别高频次缺陷条款 |
| 缺陷类别 | 高频次 缺陷条款 | 高频次缺陷条款对应 项目数（n） | 缺陷项目总数（n） | 占比/% |
|---|---|---|---|---|
| 储存与养护 | *08309 | 9 | 94 | 9.57 |
| 质量管理体系文件 | 03302 | 26 | 86 | 30.23 |
| 03401 | 20 | 23.26 | ||
| 03501 | 15 | 17.44 | ||
| 设施与设备 | 04603 | 13 | 70 | 18.57 |
| 05201 | 15 | 21.43 | ||
| 人员与培训 | 02601 | 16 | 61 | 26.23 |
| 03001 | 16 | 26.23 | ||
| 收货与验收 | 07704 | 18 | 50 | 36.00 |
| 机构和质量管理职责 | 01717 | 13 | 41 | 31.71 |
| 合计 | 161 | 402 | 40.05 |
| [1] |
张涛志, 胡永新, 邵倩倩, 等. 广东省撤销GSP证书的药品批发企业缺陷项目分析[J]. 中国药事, 2021, 35(10): 1116-1122.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [2] |
肖遥. 药品市场监管领域中药品监管工作存在的问题及对策[J]. 农村经济与科技, 2021, 32(16): 257-258; 295.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [3] |
张磊, 张秀洪, 吴正善, 等. 福建省药品GSP换证检查缺陷项目分析[J]. 中国药事, 2021, 35(7): 745-750.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [4] |
唐红, 白小琼. 药品经营企业现场检查常见问题分析[J]. 中国药业, 2020, 29(20): 16-19.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [5] |
黄炳生, 张征, 吴生齐. 广东省药品批发企业GSP跟踪检查情况分析[J]. 中国药事, 2020, 34(6): 625-631.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [6] |
周碧雯. 药品批发企业实施GSP的意义[J]. 上海医药, 2020, 41(9): 53-56; 74.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [7] |
赵凤仙. 药品经营企业实施GSP存在的主要问题与对策[J]. 医学食疗与健康, 2020, 18(4): 186-187.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [8] |
刘华, 魏莉, 刘卫平, 等. 河北省药品批发企业GSP认证检查缺陷项目分析[J]. 世界最新医学信息文摘, 2019, 19(76): 303-304.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [9] |
王兰. 浅谈如何持续强化药品经营企业GSP认证后的质量管理工作[J]. 临床医药文献电子杂志, 2019, 6(67): 184-185.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [10] |
林宗山. 药品批发企业质量管理中应用GSP的分析与研究[J]. 临床医药文献电子杂志, 2019, 6(27): 180.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [11] |
张芳. 关于药品批发企业对质量管理措施的探讨[J]. 中国卫生产业, 2019, 16(9): 70-71.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [12] |
李奎, 王雯丽. 河南省药品批发企业新版GSP跟踪检查缺陷项目分析[J]. 中国药事, 2018, 32(1): 82-87.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| [13] |
王芳, 冉大强, 林晓明. 山东省药品批发企业实施新版GSP认证检查中的缺陷项目分析[J]. 中国药房, 2016, 27(34): 4760-4763.
{{custom_citation.content}}
{{custom_citation.annotation}}
|
| {{custom_ref.label}} |
{{custom_citation.content}}
{{custom_citation.annotation}}
|
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表1 缺陷项目分布情况表2 6大缺陷类别高频次缺陷条款/
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