药品包装验证中风险评估的探讨

Discussion of Risk Assessment in Validation of Medicine Packaging

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.