Seong-Jae Yoo, PhD, & Gabriel Giancaspro, PhD, U.S. Pharmacopeial Convention (USP) 03.01.17
Almost a decade has passed since the FDA current Good Manufacturing Practice regulations (cGMPs) for dietary supplements (21 CFR Part 111) were promulgated. Unfortunately, as recent results of FDA GMP inspections indicate, many dietary supplement manufacturers are not fully complying with cGMPs, in many cases due to lack of specifications for ingredients and finished products. Monographs of the United States Pharmacopeia (USP) can be useful and important resources for those having to comply with cGMPs.
GMP Background
cGMPs were introduced as a regulatory tool with the intent to ensure the safety and quality of dietary supplement products through manufacturing rules. Products manufactured in violation of cGMPs are considered adulterated as a matter of law regardless of whether the product has any defects.
The key principle of GMP compliance is that finished product quality needs to be built into the manufacturing process. Each step of the manufacturing process needs to be controlled to lower the risks that the finished product will not comply with the established quality specif
GMP Background
cGMPs were introduced as a regulatory tool with the intent to ensure the safety and quality of dietary supplement products through manufacturing rules. Products manufactured in violation of cGMPs are considered adulterated as a matter of law regardless of whether the product has any defects.
The key principle of GMP compliance is that finished product quality needs to be built into the manufacturing process. Each step of the manufacturing process needs to be controlled to lower the risks that the finished product will not comply with the established quality specif
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