病毒性疫苗生产过程的质量风险分析

Quality Risk Analysis about the Production Process of Viral Vaccine

文章结合质量风险管理理念,识别病毒性疫苗生产过程的风险,降低产品风险,保证疫苗质量。以GMP、ICH Q9、WHO TRS981附录质量风险管理指南为基础,以病毒性疫苗为例,选用鱼骨图对生产过程进行识别,选用FMEA法对识别出的风险进行评估。对识别出的风险提出风险控制措施,及监管检查建议。质量风险管理伴随疫苗生产全过程,使用适当的风险评估工具可有效识别过程风险,为企业生产和监管检查提供建议,有效防控风险。

This paper based on the concept of quality risk management,analyzed quality risk of the viral vaccines production process,in order to ensure the quality of the product.Based on GMP,ICH Q9,and WHO TRS981 Appendix Quality Risk Management Guidelines,take viral vaccines as an example,use the quality risk management tool(Fishbond diagram、failure mode and effect analysis\FMEA)to take risk assessment.According to the quality risk assessment,the key factors have been clarified,then provide some suggestion for risk control and regulatory inspections.Quality risk management accompanies the whole process of vaccine production,use appropriate risk assessment tools can identify process risks effectively,in order to reduce quality risk.