摘要
介绍了无菌原料药企业质量风险管理体系构建与实施的背景、内涵及主要做法,以及实施质量风险管理的效果。
This article introduces the background of quality risk management system construction and implementation for sterile APIs company, the establishment and implementation of the connotation and main methods, as well as the implementation of quality risk management effect.
