Expert consensus on an open-access United Nations International Multiple Micronutrient Antenatal Preparation-multiple micronutrient supplement product specification,Annals of the New York Academy of Sciences

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Expert consensus on an open-access United Nations International Multiple Micronutrient Antenatal Preparation-multiple micronutrient supplement product specification
Annals of the New York Academy of Sciences ( IF 4.1 ) Pub Date : 2020-03-09 , DOI: 10.1111/nyas.14322
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The multiple micronutrient supplement (MMS) based on the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formula provides women and their offspring with a healthy start to life in an efficacious, safe, and cost‐effective way. To date, however, no precise and transparent specifications exist to support the manufacturing and distribution of UNIMMAP–MMS globally. To palliate for this need, the MMS Technical Advisory Group at the New York Academy of Sciences and the Micronutrient Forum convened a technical consultation to develop an open access UNIMMAP–MMS Product Specification for the manufacturing of this product. The specifications offered in this paper cover: ingredients, excipients, and processing aids used in the manufacturing of UNIMMAP–MMS; stability studies recommended under different testing conditions and climatic zones; packaging considerations; manufacturing standards, including pharmacopeia standards, manufacturing practices, certificates of analysis, change control, and quality agreement; finished product specifications, including tablet characterization and purity, potency assay; analytical test methods; and storage and transportation requirements.

中文翻译：

关于开放获取的联合国国际多种微量营养素产前准备-多种微量营养素补充剂产品规范的专家共识

基于联合国国际多种微量营养素产前准备 (UNIMMAP) 配方的多种微量营养素补充剂 (MMS) 以有效、安全和具有成本效益的方式为女性及其后代提供健康的生活开端。然而，迄今为止，尚无精确和透明的规范来支持 UNIMMAP-MMS 在全球的制造和分销。为满足这一需求，纽约科学院的 MMS 技术咨询小组和微量营养素论坛召开了一次技术咨询会议，以制定用于制造该产品的开放式 UNIMMAP-MMS 产品规范。本文提供的规格包括：用于制造 UNIMMAP-MMS 的成分、赋形剂和加工助剂；建议在不同测试条件和气候带下进行稳定性研究；包装考虑；制造标准，包括药典标准、制造规范、分析证书、变更控制和质量协议；成品规格，包括片剂特性和纯度、效力测定；分析测试方法；以及储存和运输要求。

更新日期：2020-03-09

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