疫苗生产中的风险监管策略研究

Research on the Risk Supervision Strategy during Vaccine Production

目的:对疫苗生产过程中的风险进行研究,提出相应的监管策略,以有效提高疫苗质量安全水平,保障用药安全。方法:基于质量风险管理的理念,对疫苗生产过程中的风险进行分析,从风险的角度提出疫苗生产企业存在的主要问题,并针对这些问题提出了相应的监管策略。结果与结论:疫苗生产中的风险主要来自生产用物料、生产过程、质量体系、生产变更、电子监管及贮存运输;存在的问题主要有企业对生产用物料控制把关不严、生产过程监管控制不强、企业自身质量意识与能力不高;对应策略为明确监管体制、提升质量风险意识、加强生产用物料控制、对生产全过程进行重点监管和跟踪评价、完善质量保证体系、严格执行变更程序、加强电子监管及贮存运输监督、强化生产管理和人员培训指导。

OBJECTIVE： To improve the quality and safety of vaccines and guarantee the safety of drug use by studying the risks of vaccine production and putting forward relevant regulation strategy. METHODS： Based on the concept of quality risk man- agement, the risks of vaccine production were analyzed, and main problems of vaccine manufacturers were put forward in term of risk; relevant supervision countermeasures were provided. RESULTS ＆ CONCLUSIONS： The risks of vaccine production come from production materials, production process, quality system, change of production procedure, electronic supervision, storage and transportation; main problems of vaccine manufacturers are as follows： lax production materials control, poor production pro- cess control and weak quality awareness of enterprises and skill; relevant countermeasures include： clearing supervision system, im- proving awareness of quality risk, enhancing production materials control, carrying out important supervision for whole production process, tracking and evaluation, improving QMS, implement changing procedure strictly, strengthening electronic supervision, storage and transportation and enhancing manufacturing management and personnel training.