Expert Consensus on an Open-Access UNIMMAP MMS Product Specification: 2024 revision

IF 4.1 3区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Annals of the New York Academy of Sciences Pub Date : 2024-08-21 DOI:10.1111/nyas.15204

Clayton A. Ajello, John Atwater, Jarno de Lange

{"title":"Expert Consensus on an Open-Access UNIMMAP MMS Product Specification: 2024 revision","authors":"Clayton A. Ajello, John Atwater, Jarno de Lange","doi":"10.1111/nyas.15204","DOIUrl":null,"url":null,"abstract":"<p>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.</p>","PeriodicalId":8250,"journal":{"name":"Annals of the New York Academy of Sciences","volume":"1540 1","pages":"166-177"},"PeriodicalIF":4.1000,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/nyas.15204","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of the New York Academy of Sciences","FirstCategoryId":"103","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/nyas.15204","RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}

引用次数: 0

Abstract

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.

Abstract Image

查看原文本刊更多论文

关于开放存取的 UNIMMAP 彩信产品规格的专家共识：2024 年修订版。

联合国国际多种微量营养素产前准备方案（UNIMMAP）为孕妇提供的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，已被列入世界卫生组织（WHO）基本药物示范清单。2024 年修订的《开放获取的 UNIMMAP MMS 产品规格专家共识》为采购商和制造商提供了生产 UNIMMAP MMS 的统一指导。更具体地说，它概述了生产 UNIMMAP MMS 的最低要求，并根据产品是作为医药产品还是膳食补充剂生产，提供了质量和监管标准方面的指导。产品规格包括用于生产联苯胺美沙酮的成分、辅料/食品添加剂和加工助剂；不同气候区的稳定性测试；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，包括片剂特征和纯度/强度测定；分析测试方法；以及储存和运输要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Annals of the New York Academy of Sciences 综合性期刊-综合性期刊

CiteScore

11.00

自引率

1.90%

发文量

193

审稿时长

2-4 weeks

期刊介绍： Published on behalf of the New York Academy of Sciences, Annals of the New York Academy of Sciences provides multidisciplinary perspectives on research of current scientific interest with far-reaching implications for the wider scientific community and society at large. Each special issue assembles the best thinking of key contributors to a field of investigation at a time when emerging developments offer the promise of new insight. Individually themed, Annals special issues stimulate new ways to think about science by providing a neutral forum for discourse—within and across many institutions and fields.