| 杜雅娟,郭朝晖,杨平荣,刘志浩.药品化妆品抽样及检验的有关问题探讨[J].中国药事,2020,34(4):407-411 |
| 药品化妆品抽样及检验的有关问题探讨 |
| Discussions on Sampling and Inspection of Drugs and Cosmetics |
| 投稿时间：2019-06-21 |
| DOI：10.16153/j.1002-7777.2020.04.006 |
| 中文关键词: 药品 药包材 化妆品 抽查检验 抽样 人员培训 监督和检验有机结合 抽检工作机制 |
| 英文关键词: medicines pharmaceutical packaging materials cosmetics random inspection sampling personnel training organic combination of supervision and inspection |
| 基金项目:甘肃省自然科学基金（编号18JR3RA080） |
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| 摘要点击次数: 1901 |
| 全文下载次数: 261 |
| 中文摘要: |
| 目的：对药品、药包材、化妆品抽样及检验工作中发现的问题进行分析研究，旨在为监管部门和检验机构提供参考，规范抽样和检验，提高监管效能和服务水平。方法：通过抽样、样品寄送、收样、检验等环节，对药品、药包材、化妆品抽样及检验工作中发现的有关问题进行分析研究，提出相应的解决措施和意见建议。结果与结论：部分药品/药包材/化妆品的抽查检验存在抽样不规范、抽样信息不完整、抽样与检查未能兼顾、样品寄送不规范、检验登记单和检验报告信息不完整或填写不规范、检验不规范、部分产品的批号效期标识不规范，以及部分品种因抽样量大导致抽样难以覆盖基层等问题，影响了监管效能。应根据药品、药包材、化妆品的产品特性和监管要求，分类设置并完善抽样及检验检测信息，并从强化人员培训、监督和检验有机结合、针对基层用药特点完善抽检工作机制、加强学习交流提高检验报告质量等方面加以解决。 |
| 英文摘要: |
| Objective: To analyze and study the problems found in the sampling and inspection of drugs, pharmaceutical packages and cosmetics, so as to provide references for supervision departments and inspection institutions, standardize sampling and inspection, and improve supervision efficiency and service level. Methods: Through sampling, sample delivery, sample collection, inspection and other links, the relevant problems found in the sampling and inspection of medicines, medicines and cosmetics were analyzed and studied, and the corresponding solutions and suggestions were put forward. Results and conclusions: There exist sampling irregularity, incomplete sampling information, incomplete sampling and inspection, incomplete sample delivery, incomplete registration form and inspection report information, incomplete filling in, non-standardized testing nonstandardized batch number and expiration date identification of some products and some varieties being difficult to cover the grass-roots level due to large sampling volume, which affects the efficiency of supervision. According to the product characteristics and regulatory requirements of drugs, pharmaceutical packaging materials, cosmetics,the sampling and inspection information should be classified and improved, and the intensive personnel training, supervision and inspection should be combined organically, the working mechanism of sampling and inspection should be improved, learning and communication should be strengthened, the quality of the inspection report should be improved. |
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