“中国新版GMP提出了质量风险管理的基本要求,明确企业必须对药品的整个生命周期根据科学知识和经验进行评估,并最终与保护患者的目标相关联,质量风险管理过程中,企业努力的程度、形式和文件应与风险的级别相适应。”国家食品药 “The new version of GMP in China presents the basic requirements for quality risk management. It is clear that companies must evaluate the entire life cycle of medicines based on scientific knowledge and experience and ultimately link the goals of patient protection. In the process of quality risk management, The degree, form and documentation should be appropriate to the level of risk. ”National Food and Drugs