KTA Guidelines: Current Good Manufacturing Practices (cGMPs) Standards
KTA’s guidelines adhere closely to FDA regulatory dietary supplement cGMP standards and are applicable to companies that manufacture, package, label, hold/store, or distribute raw kratom ingredients or kratom products.
The entire set of FDA standards is found at 21 C.F.R. Part 111, which are meant to be tailored by each regulated entity to its own particular functions. For example, if an entity only distributes kratom products (e.g., receives packaged and labeled product from another entity, warehouses that inventory while sales are in process and then ships to the customer without any processing or re-packaging), then only distribution and holding requirements likely will apply to its facility. Each company’s quality system should be appropriately scaled to cover the activities it actually performs.
Many of the responsibilities below may be outsourced to third parties or conducted with assistance from a third party, e.g., labs that conduct testing for pathogens, establishment of specifications for your product. However, you ultimately are responsible for ensuring your own compliance, so we recommend conducting appropriate due diligence when selecting any contracting parties. KTA resources may be useful to members in this regard.
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Going through the NDIN process; can seem overwhelming. Part of your businesses protocol will include using a cGMP Compliant facility; check out this informative video from American Herbal Products Association, a leader in the natural products industry.
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