{"title":"关于开放存取的 UNIMMAP 彩信产品规格的专家共识：2024 年修订版。","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":"{\"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}","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}
Expert Consensus on an Open-Access UNIMMAP MMS Product Specification: 2024 revision
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.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
