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关于开放访问的UNIMMAP MMS产品规范的专家共识:2024年修订版
Clayton A Ajello1, John Atwater1, Jarno de Lange2
1Kirk Humanitarian, Salt Lake City, Utah, USA.
Annals of the New York Academy of Sciences
|August 21, 2024
概括
更新的UNIMMAP MMS产品规范为孕妇制造必需微量营养素补充剂提供了统一的指导. 这确保了全球买家和制造商的质量和监管合规性.
科学领域:
- 公共卫生 营养 公共卫生 营养
- 孕产妇健康 孕产妇健康
- 制药科学 制药科学
背景情况:
- 联合国国际多种微量营养素产前制剂 (UNIMMAP) 是一个重要的,基于证据的孕妇营养干预措施.
- 在世界卫生组织 (WHO) 的基本药物榜单中,UNIMMAP得到了认可,这突显了其在全球的重要性.
- 现有的指南需要更新,以反映当前的制造和监管环境.
研究的目的:
- 为买家和制造商提供统一的,更新的指导,生产UNIMMAP多种微量营养素补充剂 (MMS).
- 概述UNIMMAP MMS的最低制造要求,质量和监管标准.
- 确保在全球范围内为孕产妇健康提供高质量的MMS的持续生产.
主要方法:
- 对开放访问UNIMMAP MMS产品规范的专家共识的修订.
- 包括关于成分,辅助剂,加工辅助剂和稳定性测试的详细指南.
- 药库标准,制造实践和质量控制措施的规范.
主要成果:
- 为UNIMMAP MMS.一个全面的2024年修订的产品规范.
- 制造,质量保证和监管合规性的详细要求.
- 针对作为药品或食补充剂制造的产品量身定制的指导.
结论:
- 修订后的规范为UNIMMAP MMS的一致和高质量的生产提供了必要的,统一的指导.
- 此更新支持全球努力通过补充必需微量营养素来改善孕产妇营养.
- 确保遵守质量和监管标准,促进更广泛地访问UNIMMAP MMS.
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