【日积月累】It is important to understand that product quality is assured based on appropriate risk-based decision-making throughout the product life cycle, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective.
It is important to understand that product quality is assured based on appropriate risk-based decision-making throughout the product life cycle, such that the attributes that are important to the quality of the drug (medicinal) product are maintained and the product remains safe and effective. 重要的是要了解,在整个产品生命周期中,产品质量是根据基于风险的适当决策来保证的,这样对药物(医疗)产品质量至关重要的属性才能得到保持,并且产品保持安全有效。--ICH Q9 《风险管理》