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Key Differences Between Dietary Supplement and Drug GMP Requirements
In general, when comparing 21 CFR 111 vs 21 CFR 211 there are many similarities between the two GMP requirements but clear differences in the level of detail and commitment. Additionally there are the unwritten expectations of the FDA that can only be determined during an inspection, or from industry experts, or from 483 warning letters issued to competitors. We discuss all of this here in this article.