摘要
目的:为药品监管部门的监督抽检工作提供依据。方法:统计珠海市近五年的药品抽检结果,并对结果进行分析。结果:五年累计抽检3713批次,其中不合格61批次,不合格率为1.64%;按照样品品种统计分析,中药材及饮片的不合格率最高;按照不合格项目统计分析,中药材及饮片中的水分不合格率最高。结论:2017年至2021年,珠海市药品抽检整体质量情况良好;建议从提高思想站位、科学安排抽样工作、加强药品检验检测机构能力建设、完善检验检测标准等方面做好药品监管的技术支撑。
Objective:To provide reference for drug supervision departments.Methods:Analyzing the result of of drug sampling and testing in Zhuhai nearly five years.Results:A total of 3713 batches of drug sampling tests were completed in the five years,with 61 batches of unqualified samples,and the unqualified rate was 1.64%.According to the analysis of drug type,the unqualified rate of traditional Chinese medicine and prepared slices were highest.According to the analysis of testing items,the unqualified rate of water determination in traditional Chinese medicine and prepared slices were highest.Conclusion:The overall quality of Zhuhai drug sampling and testing in 2017 to 2021 is good.It is suggested that improving ideological understanding,arranging sampling work scientifically,capacity building of drug testing institutions,improving quality standard to provide technical support for drug market supervision.
作者
黄昕
吴愫青
HUANG Xin;WU Suqing(Zhuhai Institute of Food and Drug Control,Zhuhai Guangdong 519000,China)
出处
《药品评价》
CAS
2022年第10期592-594,共3页
Drug Evaluation
关键词
药用制剂
批质量保证抽样法
产品监测
售后
抽检
质量分析
Pharmaceutical preparations
Lot quality assurance sampling
Product surveillance
postmarketing
Sampling and testing
Quality analysis
