我国将注射剂、生物制品和特殊药品列为高风险产品进行重点监管,而疫苗又是高风险产品监管的重中之重,本文旨在通过对三个疫苗品种生产工艺的关注,将风险关口前移至生产阶段,探究产品形成之前可能发现危险因素的各个环节,拓宽疫苗质量控制的思路,规避疫苗的使用风险。 China will be injections, biological products and special drugs as a high-risk products to focus on regulation, and vaccines are the top priority for the regulation of high-risk products, this paper aims at the three vaccine varieties of production technology concerns, the risk before Move to the production stage, explore all aspects of risk factors that may be found before the product is formed, broaden the train of thought on vaccine quality control and avoid the risk of using the vaccine.