摘要
目的进一步提高药品应急检验应对能力。方法采用回顾性研究的方法,对江苏省食品药品监督检验研究院2019年亚硝胺类基因毒性杂质专项应急检验全过程工作进行梳理。结果总结了专项应急检验中各环节的处置流程、管理特点和难点,提炼处置经验教训。结论应急检验工作是对检验机构应急响应能力、技术实力的全面考验。需从事前、事中和事后制订系统的应对策略,构建完善的药品应急检验管理体系。
OBJECTIVE To improve the emergency response ability to drug inspections. METHODS This paper reviews and summarizes the special emergency test for Nitrosamine genotoxic impurities in 2019, and analyzes the characteristics and difficulties on emergency inspection management. RESULTS The work of emergency inspection is a comprehensive test of the emergency response ability and technical strength. CONCLUSION It is necessary to formulate systematic coping strategies before, during and after the event, and to build a perfect drug emergency inspection and management system.
作者
黄青
赵恂
黄敏文
袁耀佐
张玫
HUANG Qing;ZHAO Xun;HUANG Min-wen;YUAN Yao-zuo;ZHANG Mei(NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Jiangsu Institute for Food and Drug Control,Nanjing 210019,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2020年第23期1923-1925,共3页
Chinese Pharmaceutical Journal
关键词
药品检验
应急检验
管理体系
基因毒性
亚硝酸类
杂质
drug inspection
emergency inspection
management system
genotoxic
nitrous acid
impurity
