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Dietary Supplement GMPs Imbued With Quality Systems Concepts

This article was originally published in The Gold Sheet

Executive Summary

NEW QUALITY SYSTEMS-ORIENTED GMPS will draw attention from outputs to inputs for dietary supplements, as quality systems guidance aims to do for drug GMPs. The supplement GMPs allow testing of subsets of product batches, identified by statistical sampling plans. Though 100 percent identity testing of each batch of incoming dietary ingredients is required, manufacturers can petition FDA for reduced identity testing. Suppliers are not subject to the rule, but that could change

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