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
Multiple Micronutrient Supplement Technical Advisory Group (MMS-TAG), Micronutrient Forum (MNF)

Abstract

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.

References

May 17, 2019·Annals of the New York Academy of Sciences·Alison D Gernand
May 28, 2019·Annals of the New York Academy of Sciences·Megan W BourassaStephen A Vosti

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