基于产品生命周期的疫苗质量风险管理研究

目的：明确产品生命周期各阶段质量风险管理重点工作及控制措施，为产品全生命周期质量风险管理提供有力保障。方法：以GMP、PIC/s GMP附件20、ICH Q8、ICH Q9、ICH Q10、ICH Q12、WHO质量风险管理指南为基础，运用归纳总结及分析评估方法，对疫苗产品生命周期各阶段的质量风险管理进行研究。结果：通过质量风险管理研究，明确了生命周期不同阶段影响疫苗质量的关键因素，以满足科学和法规符合性为基础，提出具体控制措施，有效防控质量风险。结论：质量风险管理伴随疫苗产品全生命周期，任何一个阶段的质量风险管理工作都需重视并认真执行，采取科学合规的控制措施，可达到有效防控质量风险的目的。

Research on Vaccine Quality Risk Management Based on Product Life Cycle

Objective: To clarify key work and control measures for quality risk management at all stages of product life cycle so as to provide a strong guarantee for quality risk management in the whole product life cycle. Methods: Based on GMP, appendix 20 of PIC/s GMP, ICH Q8, ICH Q9, ICH Q10, ICH Q12 and WHO guideline of quality risk management, the quality risk management at all stages of product life cycle of vaccine products was studied by the methods of induction and summarization, analysis and evaluation. Results: Through the study of quality risk management, the key factors affecting vaccine quality in different stages of the life cycle were clarified. Based on the scientific and regulatory compliance, specific control measures were taken to effectively prevent and control quality risks. Conclusion: Quality risk management is accompanied by the whole life cycle of vaccine products. Quality risk management at any stages should be paid attention to and implemented carefully. Scientific and compliant control measures should be applied to achieve effective prevention and control of quality risk