Expert consensus on an open-access United Nations International Multiple Micronutrient Antenatal Preparation–multiple micronutrient supplement product specification

The Multiple Micronutrient Supplementation (MMS) Technical Advisory Group (TAG) at the New York Academy of Sciences (NYAS) and the Micronutrient Forum (MNF) convened a technical consultation to develop an open access United Nations International Multiple Micronutrient Antenatal Preparation (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.