Tablets & Capsules

TC1015

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W 32B October 2015 Tablets & Capsules quality The buck stops where? Clarifying GMP responsibility under quality agreements Justin Prochnow Greenberg Traurig Distributors of private-label dietary supplements that rely on con- tract manufacturers are nonetheless liable for failures to comply with cGMPs. This article examines how a well-crafted quality agreement can help ensure compliance and avoid FDA warning letters or other enforcement action. hile the current good manufacturing practice (cGMP) regulations outlined in 21 CFR Part 111 have been the focus of FDA inspections of dietary supplement manufac- turers, own-label distributors (OLDs)—also known as pri- vate-label retailers—who outsource production to a con- tract manufacturing organization (CMO) are not off the hook when there is a failure to comply with cGMP. In fact, in the last 2 years, the FDA has issued at least 29 warning letters to OLDs for cGMP non-compliance. All 29 letters stated, "Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate respon- sibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement

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