Although CBD is currently neither a dietary supplement nor a food additive, the groundwork for submission of safety data to obtain a new NDI (New Dietary Ingredient) is underway. Regardless of how long this takes, the market is so large that regulation in this area is inevitable. cGMP will be a requirement. In the CFR 21, part 111 regulations ( Congressional Federal Register) regarding cGMP for dietary supplements, there are over 16 subparts that deal with the rules of the road when it comes to manufacturing. These subparts provide the guidelines to be followed when writing SOP’s that will satisfy the laws for full cGMP compliance.
The FDA keeps historical data on enforcements that have been issued for dietary supplement manufacturers, and when analyzing it, we see that three (3) significant areas are targeted in inspections.
#1 Inadequate Product Specifications
This is found in the CFR21; part 111.70, “What specifications must you establish?” The Product Specification (PS) must contain a complete description of the product in detail.
- The packaging components must be verified food grade.
b.) The ingredients purchased must have the necessary documentation on file for rapid retrieval.
c.) All of the testing required to ensure the safety of the product must be authenticated. This is where your Product Specification will most likely be deficient. You need to have a supplier approval process for the product ingredients. In the case of CBD, the PS must contain the purity tests (ie. microbiological, heavy metals, and the strength of the CBD ( actual quantity per unit). If you are using an outside lab, this lab should be approved and accredited. You must have a supplier approval methodology established and implemented.
All of the above elements in the Product Specification require documentation and the creation of detailed Standard Operation Procedures that can be stored in your cloud server for rapid retrieval.
I am committed to helping small and medium-sized enterprises develop and create cGMP document management systems at a very competitive cost.
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