摘要
工艺验证是药品生产验证的重中之重。本文根据生产工艺验证的实践经验,从工艺验证的介入时间、验证策略、验证风险管理和验证执行等方面总结了血液制品工艺验证的一些心得体会。
Process validation is the most important one of the validations done for pharmaceuticals manufacturing. Ac- cording to the production practice of process validation, this paper summarizes some feelings and experiences what we learn about intervention time, validation strategy, validation risk management and implementation of the practices in process validation of blood products.
出处
《中国当代医药》
2013年第8期161-163,共3页
China Modern Medicine
关键词
工艺验证
验证策略
风险管理
血液制品
Process validation
Validation strategy
Risk management
Blood products
