疫苗产品全生命周期外源因子安全性风险评估及质量控制探讨

Safety Risk Assessment and Quality Control of Adventitious Agents Throughout the Life Cycle of Vaccine Products

目的探讨对疫苗生产过程及上市后产品进行外源因子安全性风险评估的方法及其质量控制的要求与原则。方法根据生物制品病毒安全性相关法规及指导原则,参考近年来监测到的外源因子对疫苗产品带来的安全性风险,分析疫苗生产过程中外源因子风险及上市后疫苗产品病毒安全性追溯和风险防控措施。结果对疫苗产品及其全生命周期外源因子风险性评价及质量控制给出建议,并总结出各环节的质量控制原则。结论该研究可望为研究者、生产企业和监管机构提供一定借鉴。

Objective To investigate the method of safety risk assessment and the requirements and principles of quality control of adventitious agents,through the time of production process and post-marketing of vaccine products.Methods Based on related regulations and guiding principles of biological products viruses'safety and the safety risk from adventitious agents in vaccine products monitored in resent years,the risk of adventitious agents through the process of vaccine production,viral safety tracing,risk prevention and control measures in post-marketing vaccine products were analyzed.Results Making recommendations for the risk assessment,quality control for vaccine products and adventitious agents in them,then summarizing the quality control principles in all links.Conclusion This study may provide a reference for researchers,production companies and regulators.