Expert consensus on an open‐access United Nations International Multiple Micronutrient Antenatal Preparation–multiple micronutrient supplement product specification
The Multiple Micronutrient Supplement Technical Advisory Group (MMS‐TAG), The 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.