疫苗的质量管理与监管检查

Vaccine Quality Management and Regulatory Inspection

疫苗直接用于健康人群,尤其是新生儿和青少年,与人民的健康联系紧密,属于高风险的特殊商品。疫苗的生产与质量控制过程十分复杂,疫苗生产企业必须运用质量风险管理的理念,进行全过程的质量管理才能保证其质量。疫苗生产周期长、很多关键产品质量指标不能从最终产品放行检验中获得,只有将检查重点置于疫苗生产与质量控制的高风险环节,才能降低检查工作本身存在的风险。

Vaccine is used in healthy people directly, especially the newborns and youth. It is in close contact with the public health. And it belongs to high-risk merchandise. The production and quality control process for vaccine is very complex. In order to ensure the vaccine quality, the manufacturers must adopt quality risk management approach and use it to the whole process of quality management. As the vaccine production cycle is long, and many key quality indicators could not be found through final product release testing. The regulatory inspection works become hard. To reduce the risk, it is important to go through the high-risk areas of the vaccine production and quality control during the inspection.