• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

快速检索引用检索图表检索高级检索

中国医药导刊 ›› 2020, Vol. 22 ›› Issue (5): 351-355.

所属专题: 智慧监管专栏

• 智慧监管专栏 • 上一篇    下一篇

化妆品生产企业实验室管理缺陷分析及建议——基于国家药品监督管理局2018—2019年化妆品飞行检查结果

王颖香1,于淼2, 张薇薇1, 席晓宇1*,顾淼2*   

  1. 1. 中国药科大学国家药物政策与医药产业经济研究中心,江苏 南京 211198;
    2.国家药品监督管理局信息中心, 北京 100044
  • 收稿日期:2020-02-20 修回日期:2020-04-19 出版日期:2020-05-31 发布日期:2020-06-19
  • 基金资助:
    国家药品监督管理局信息中心委托项目(项目编号:2019NMPAICKY04;项目名称:互联网+药品生产监管数据融合分析研究);中国药科大学“双一流”学科创新团队建设项目(项目编号:No.CPU2018GY39)

Analysis and Countermeasures of Laboratory Management Defects in Cosmetics Manufacturing Enterprises——Based on the Results of the National Cosmetics Unannounced Inspection from 2018 to 2019

  1. 1. The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Jiangsu Nanjing 211198, China;
    2. Center For Information, National Medical Products Administration, Beijing 100044, China
  • Received:2020-02-20 Revised:2020-04-19 Online:2020-05-31 Published:2020-06-19

摘要: 目的:探索我国化妆品生产企业在实验室管理中存在的缺陷,分析这些缺陷存在的原因并提出解决策略,以促进国内化妆品质量安全。方法:收集国家药品监督管理局官方网站2018年1月至2019年12月公布的化妆品生产企业飞行检查通报,运用SPSS软件将原本的非结构化数据转化成结构化数据,通过综合数据分析方法,探究化妆品生产企业在实验室管理中的缺陷。结果:共有53家化妆品生产企业存在实验室管理缺陷,主要缺陷项包括检验记录不合格(占比45.28%)、检验能力不足(占比20.75%)、仪器和设备管理不合格(占比35.85%)以及试剂管理不合格(占比24.53%)。 结论:生产企业应当完善质量管理体系,提升内部人员素质能力,保障物资的供应,建立完善的信息化管理系统以加强实验室管理,从源头上保障化妆品质量安全。

关键词: font-size:medium, ">化妆品;飞行检查;生产企业;质量;实验室管理

Abstract: Objective: To explore the defects in the laboratory management of cosmetics manufacturers in China, and analyze the reasons for these defects and propose solutions to promote domestic cosmetics quality and safety. Methods: The bulletins on unannounced inspection to cosmetics manufacturers on the official website of National Medical Products Administration(NMPA) issued from January 2018 to December 2019 were collected. SPSS software was used to transform the original unstructured data into structured data, and the comprehensive data analysis method was used to explore the defects of cosmetics manufacturers in laboratory management. Results: The results showed that during the above period, a total of 53 cosmetic manufacturers had laboratory management defects, including unqualified inspection records (accounting for 45.28%), inadequate inspection ability (accounting for 20.75%),unqualified instrument and equipment management (accounting for 35.85%) and unqualified reagent management(accounting for 24.53%).Conclusion: Enterprises should improve the quality management system, improve the capability of internal personnel, ensure the supply of materials and establish a comprehensive information management system to strengthen laboratory management, and ensure the quality and safety of cosmetics from the source.

Key words: font-size:medium, ">Cosmetics; Unannounced inspection; Manufacturing enterprise; Quality; Laboratory management

中图分类号: