通过使用标准来保持疫苗的质量:当前的挑战和未来的机会
Nancy C Sajjadi1, Ryan Brady2, Carmen Jungbäck3
1Sajjadi Consulting, Fairfax, VA, USA.
概括
国际标准 (IS) 和国际单位 (IU) 对疫苗质量至关重要. 疫苗技术的不断发展需要更新标准和更大的监管协调全球卫生.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 监管科学 监管科学
- 生物技术是生物技术.
背景情况:
- 从历史上看,国际标准 (IS) 和国际单位 (IU) 确保了人类和动物疫苗的质量.
- 疫苗制造和测试的技术进步扩大了标准的类型和应用.
- 由于疫苗产品复杂性增加,多样性增加,以及向体外测试转移,利益相关者的需求正在转变.
研究的目的:
- 讨论关于制定和实施疫苗标准的原则和最佳实践.
- 为应对技术进步,应对疫苗标准不断变化的局面.
- 促进利益相关者之间的合作和协调监管期望.
主要方法:
- 召开了监管机构,科学家和行业专家的国际混合会议.
- 促进了关于疫苗标准的挑战和建议的讨论.
- 收集了有关当前和未来需求的各种利益相关者的观点.
主要成果:
- 确定了不断发展的国际和内部标准的需要,以与技术进步相匹配.
- 强调用体外质量属性测量取代基于动物的强度测试的重要性.
- 强调需要通过协作努力更好地协调监管期望.
结论:
- 疫苗标准的不断发展对于跟上科学技术进步至关重要.
- 标准制定组织,国家控制实验室和制造商之间的加强合作至关重要.
- 协调的监管方法是确保全球疫苗质量和可访问性的关键.
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