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

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.