摘要
结合药品企业生产实际,通过引入风险评估的方法,识别高风险因子,建立包装验证决策树帮助药品生产企业评估包装验证需求,减少资源浪费,提升包装验证活动的效率和价值。
Combined with practical situations in pharmaceutical enterprises, and by using risk assessment method, high risk factorwas recognized. The decision tree for packaging validation was established, which was used for assessing requirements in packagingvalidation so as to reduce resource waste, increase the efficiency of packaging validation.
作者
闵伟伟
Min Weiwei(Wyeth Pharmaceutical Co.,Ltd,Suzhou 215128)
出处
《化工与医药工程》
2018年第6期33-36,共4页
Chemical and Pharmaceutical Engineering
关键词
风险评估
包装验证
决策树
risk assessment
packaging validation
decision tree