在认识到制造商对其所生产的疫苗质量负责的同时 ,世界卫生组织 (WHO)提出了“保证质量的疫苗”的定义。保证质量的疫苗的定义是通过独立的评审系统评定 ,疫苗在纯度、效价、安全性和有效性方面符合适当的标准。此评审系统应利用全部已有的资料 ,如批准的资料、现场实施的监督、逐批复查、适合的实验室检测、企业的 c GMP检查和临床试验评价 ,这些工作一般由职能管理当局承担。定义还指出了通过加强国家管理当局工作来提高疫苗质量的途径。坚持有效的管理监督 ,同时认识到在选择疫苗使用时风险分析的作用 ,WHO特别重申了单一质量标准的必要性。根据对特定人群的风险 /效益权衡 ,只有保证质量的疫苗可考虑用于国家免疫规划 While recognizing that manufacturers are responsible for the quality of the vaccine they produce, the World Health Organization (WHO) has proposed the definition of “vaccine of quality assurance.” Vaccine quality assurance is defined by an independent review system and vaccines meet appropriate standards for purity, potency, safety and efficacy. This review system should make use of all available information, such as approved information, on-site supervision, batch reviews, suitable laboratory tests, cGMP inspections and clinical trial evaluations by the functional management authority. The definition also points to ways to improve the quality of vaccines by strengthening the work of national regulatory authorities. Insisting on effective regulatory oversight, recognizing the role of risk analysis in selecting vaccine use, WHO reiterated the need for a single quality standard in particular. Based on the risk / benefit trade-offs for specific populations, only quality-assured vaccines can be considered for use in the National Immunization Program