机电信息Issue(11)：10-13,4.
风险管理在药品生产工艺验证中的应用
Application of Risk Management in the Drug Production Process Validation
黄雪 1梁毅1
作者信息
- 1. 中国药科大学国际医药商学院，江苏南京210009
- 折叠
摘要
Abstract
Applied risk management throughout the process validation cycle, taking quality risk management tools to assess the drug production process, determine the critical steps and key process parameters. Than make the validation plan. By using the risk management can effectively improve the pertinence of drug production process validation, and it can also improve the efficiency of drug production process validation, reduce the commercial production scale production risks that may occur in the future.关键词
生产工艺/工艺验证/风险管理Key words
Production Process/Risk management/Process validation引用本文复制引用
黄雪,梁毅..风险管理在药品生产工艺验证中的应用[J].机电信息,2016,(11):10-13,4.
