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 […]
Standard Operating Procedures are the backbone of a certifiable document management program for Food or Dietary Supplements manufacturers.
The entrepreneurial smaller manufacturing companies In the hemp derivative sector are at a competitive disadvantage without a cGMP document system. The real issue here is the actual expense and investment required to hire a 3rd party regulatory & […]
Currently in the CBD Oil processing space there is a need for those companies to create SOP’s to structure and ensure the safety of their finished product. There are over 15 sections or chapters that need to be written to comply with the standards set by the FDA here in the U.S. as well as […]
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As the category has expanded into a more “lifestyle-fitness approach, the benefits of vegan-based protein sources are becoming more evident in this category. While whey protein is still the champion of Protein digestibility scores and biological value, this trend is powerful and product palatability is key. Nutrition 50 […]
Batch Record means Manufacturing documentation, packaging documentation, and exception documentation, such as a non-conformance report, Deviation Report and Certificate of Analysis, and additional documentation, which may have been processed as part of the production and packaging records of the Batch; as defined in 21 CFR part 110 and/or 111, or other certifying bodies as specified […]
If you are, you will be required one way or another, in the near future to comply with CFR 21 Part 110 or 111, for Food or Dietary Supplements. If you are a brand, not manufacturing your product offerings, you will need:
Subpart M Holding and Distributing
Subpart N Returned Finished Goods
Subpart O Product […]
This is also a fairly large issue in the general dietary supplement market with smaller manufacturers not complying with cGMP regulations. It really isn’t just hemp’. Nutrition 50 is currently writing cGMP documents for smaller manufacturers who understand they need compliance. We do at a lower cost and with a more customized approach helping to […]
Importation documentation can be very time consuming and requires in many cases authentications and apostilles from states and sovereign consulates. I have been working in the international sector for over 15 years. Selling your offerings overseas once you get through the registration process can be a very lucrative channel broadening your revenue portfolio. Nutrition 50 […]
It is apparent that the regulatory front is accelerating in this category. There are safety concerns and smaller entities are producing products with no cGMP documentation in place. That means that if you are a smaller producer without documented quality systems in place, you are at risk. Additionally, to be able to improve and grow […]
