Qualifying raw materials is probably one of the toughest tasks faced by contract manufacturing organizations. Intentional or not, 21 CFR 111 excluded raw material suppliers from cGMP (current good manufacturing practice) regulations. For now, the burden of sourcing raw materials and ensuring they meet identity, potency and purity continues to fall on the contract manufacturer, not the brand owner.

Over the past few years, various ingredient suppliers began marketing the wonders of their branded raw materials to brand owners, rather than shopping their products to the contract manufacturer.

This is done with the hope that the brand owner will specify these ingredients in its formulas, ensuring positive exposure for the supplier’s ingredient and efforts.

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