AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

Challenges with manufacturing products in multiple countries with diverging regulations

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Objective study

• Overall (process) variability in finished product comprises three main sources: 1. Manufacturing process 2. Materials/ingredients 3. Analytical method performance • Analytical performance on assessment of product compliance often not considered with new/changed regulations. • Estimate if current regulatory requirements for IF (Min, Max, Tol) can be enforced with SPIFAN methods. • IF, FSMP for infants, FuF (6-36 months, 1-3y) • vitamins A, D, E, K 1 , B 1 , B 2 , B 6 , B 12 , C, biotin, pantothenic acid, folic acid, inositol, Fe, Cu, Zn, Se, Cr, Mo, Mn and I. • Brazil, China, Europe, India, Indonesia, Malaysia, Mexico, Pakistan, Philippines, Russia/Belarus/Kazakhstan, Singapore, South Africa, Thailand, United States. • Average for product group and not accurate for specific products.

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