Drug is a special commodity closely related to people's health. Drug quality has become the focus of widespread concern in the society. In the field of medicine, the quality of API has a direct impact on the quality of drugs, and is a key link in the pharmaceutical industry chain. It belongs to the upstream products, but also relates to many products in the downstream links. In the production of active pharmaceutical ingredients, involving a variety of chem. reaction, has a very high environmental protection, safety requirements, higher risk in the process of production, "Drug Production Quality Management Norms" in our country, to the enterprise to establish risk management system has carried on the related regulations and requirements, in the current pharmaceutical quality system effectively integrate risk management, become the important problem. This paper analyzes the risks in the production process of API, and discusses the reasonable risk management measures, which lays a good foundation for its actual implementation.