摘要
目的:回顾与分析国家药品抽检质量提示工作,为我国药品质量管理提供参考。方法:梳理国家药品抽检质量提示工作流程,对2018-2019年539份质量提示数据的核查反馈数据进行分析,提出相关药品监管建议。结果:依据国家药品抽检探索性研究成果,对企业应重点关注的质量风险因素进行质量提示,企业经排查、分析和验证,采取了优化工艺、加强生产过程管理、完善标准等措施以提升药品质量管理水平。结论:国家药品抽检质量提示工作,发挥了药品监督和服务企业的作用,提升药品质量管理工作富有成效。
Objective:To review and analyze the drug quality alert in the drug sampling and testing,and provide reference for the drug quality administration of China.Methods:The workflow of drug quality alert in the drug sampling and testing was Sorted out,539 drug quality alert data and verification feedback data were analyzed,and suggestions on the enhancement of drug administration were proposed.Results:According to the results of exploratory research in the drug sampling and testing,drug quality alert on quality risk factors that should be emphasized was carried out.After investigation,analysis and verification,enterprises had taken measures such as optimizing technological parameters,strengthening manufacture process management and perfecting standard system etc,so as to advance the level of drug quality management.Conclusion:The drug quality alert in the drug sampling and testing has fully played its functional role in drug quality administration and serving business,and effectively improve drug quality management.
作者
朱炯
王胜鹏
刘文
王翀
Zhu Jiong;Wang Shengpeng;Liu Wen;Wang Chong(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药事》
CAS
2020年第8期909-915,共7页
Chinese Pharmaceutical Affairs
关键词
药品抽查检验
探索性研究
药品质量提示
drug sampling and testing
exploratory research
drug quality alert
