Expert Consensus on an Open-Access UNIMMAP MMS Product Specification: 2024 revision,Annals of the New York Academy of Sciences

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Expert Consensus on an Open-Access UNIMMAP MMS Product Specification: 2024 revision
Annals of the New York Academy of Sciences ( IF 4.1 ) Pub Date : 2024-08-21 , DOI: 10.1111/nyas.15204
Clayton A Ajello ₁ , John Atwater ₁ , Jarno de Lange ₂

Affiliation

The United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) of a multiple micronutrient supplement (MMS) for pregnant women is a proven evidence-based nutrition intervention and is listed on the World Health Organization (WHO) Model List of Essential Medicines. The 2024 revision of the Expert Consensus on an Open-Access UNIMMAP MMS Product Specification provides both purchasers and manufacturers with unified guidance on the production of UNIMMAP MMS. More specifically, it outlines the minimum requirements for the manufacture of UNIMMAP MMS and provides guidance on quality and regulatory standards based on whether the product is manufactured as a medicinal product or a dietary supplement. The product specification includes ingredients, excipients/food additives, and processing aids used in manufacturing UNIMMAP MMS; stability testing for different climatic zones; packaging and labeling considerations; pharmacopeial standards, manufacturing practices, certificates of analysis, change control, and quality agreement; finished product test specifications, including tablet characterization and purity/strength assay; analytical test methods; and storage and transportation requirements.

中文翻译：

关于开放获取的 UNIMMAP MMS 产品规范的专家共识：2024 年修订版

联合国国际多种微量营养素产前制剂（UNIMMAP）为孕妇提供多种微量营养素补充剂（MMS），是一种行之有效的循证营养干预措施，并被列入世界卫生组织（WHO）基本药物标准清单。2024 年修订版的《开放获取 UNIMMAP MMS 产品规范专家共识》为购买者和制造商提供了关于 UNIMMAP MMS 生产的统一指导。更具体地说，它概述了制造 UNIMMAP MMS 的最低要求，并根据商品是作为医药产品还是膳食补充剂生产，提供质量和监管标准指南。产品规格包括用于制造 UNIMMAP MMS 的成分、辅料/食品添加剂和加工助剂;不同气候带的稳定性测试;包装和标签注意事项;药典标准、生产规范、分析证书、变更控制和质量协议;成品测试规格，包括片剂表征和纯度/强度测定;分析测试方法;以及储存和运输要求。

更新日期：2024-08-21

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