摘要
目的:建立药品生产风险评估模型,为依风险发起GMP检查提供科学依据。方法:利用风险管理工具、统计学手段,依据企业自身风险、企业合规历史、接受检查频次为风险指标,建立药品生产风险评估模型并不断优化。结果与结论:综合企业风险和监管风险,制定药品生产风险评估模型,提高了GMP检查的指向性、科学性、计划性。
Objectives:To establish a risk ranking model and provide scientific basis for prioritizing GMP inspections.Methods:The risk assessment model of drug production was established and continuously optimized based on risk management tools and statistical means,and using the enterprise's own risk,the enterprise's compliance history and the frequency of inspection as risk indicators.Results&Conclusion:The risk assessment model of drug production developed by integrating both company and regulatory risks can improve the directivity,scientificity and planning of GMP inspection.
作者
曹嘉成
张书卉
焦灵利
CAO Jiacheng;ZHANG Shuhui;JIAO Lingli(Center for Drug Certification and Evaluation,Jiang su Food and Drug Administration,Nanjing 210002,China)
出处
《药学与临床研究》
2020年第3期229-232,共4页
Pharmaceutical and Clinical Research
关键词
药品生产
GMP检查
风险管理
模型构建
Drug production
GMP inspection
Risk management
Model construction
