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FDA GMP compliance demands

FDA GMP compliance demands.jpg
FDA is diving deeper in GMP (good manufacturing practice) requirements and asking for more details during its site inspections.

Manufacturing a product on behalf of another company is common, and opportunity for this kind of partnership abounds for food and supplement brands. Both ends of the arrangement include agreed-upon obligations.


However, in this slice of the business world, the relationship additionally involves regulatory requirements known as GMPs (good manufacturing practices) for dietary supplements. FDA serves as a silent third-party overseer to all arrangements between contract manufacturers and their customers.

However, it seems that over the course of years (nearly a dozen for supplement GMPs), the message still isn’t completely understood. Please allow for a wakeup call here: Time’s about up.

That third-party overseer continues to do its job of inspecting and finding companies aren’t following all necessary regulations. FDA is delving deeper into the regulatory requirements, looking with greater attention to detail and applying more punitive measures if the respondent isn’t committed to full compliance.

Manufacturing inspection findings show a lack of basic requirements. More issues are arising now that FDA is digging deeper into the operations. It is vital that supplement brands understand current inspection activities. One popular approach to compliance involves adding concerns that are the focus of inspections. At some point though, the regulatory obligations--all of them--must be fulfilled.

Here is an inside secret: The FDA desires—at a minimum—that companies comply with previously noted compliance issues and, if complete compliance is not demonstrated, at least progress is being made in a notable fashion. This is not a free pass for non-compliant behavior, but rather the opportunity to improve on the systems and compliant practices in place, while moving toward complete compliance. This is a rational approach. The trick is in the execution and commitment to what can be reasonably performed.

This is an abridged version of the article “FDA demanding more detailed GMP compliance”; read the full article as well as others that explore a brand’s relationship with its third-party service providers in INSIDER’s contract manufacturing digital magazine.

As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.

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