质量风险管理在医药工程设计中的应用

Application of Risk Quality Management in Pharmaceutical Engineering Desin

质量风险管理是质量管理体系的一个重要组成部分,是一个贯穿于产品生命周期的对其质量风险进行评估、控制、沟通和审核的系统化过程。质量风险管理的方法及在医药工程设计中的应用以满足药品生产质量管理规范的要求,举例说明在无菌制剂的设计中质量风险管理的应用方法。

Quality risk management is one important part in quality management system, and it is the process to assess, control, communicate and verify quality risks existed in whole life of products. The methods of quality risk management and its application in pharmaceutical engineering design shall meet the requirements in pharmaceutical production quality management code. In this article, some examples were used to explain the application of methods in quality risk management for aseptic injection products.