The passage of the 2018 United States Agriculture Improvement Act removed industrial hemp, defined as Cannabis sativa L. containing less than 0.3% THC content by dry weight, from Schedule I of the Controlled Substances Act and made it an agricultural commodity.
Currently all dietary supplement manufacturers are required to implement the cGMP codes and regulations found in the […]
If you are a small manufacturer of dietary supplements, hemp oil derivatives, or functional foods, here’s how I can help you.
I create a document management system for cGMP compliance that is low cost and high quality.
I will create standard operating procedures (SOP’s), Master Manufacturing Records, and a complete management system to comply with CFR 21 […]
Quality Control Operations
Although CBD is neither a dietary supplement nor a food additive, the groundwork for submitting safety data to obtain a new NDI (New Dietary Ingredient) for CBD is underway. Regardless of how long this takes, the market is so large that regulation is inevitable.
The FDA often cites written Quality Control Operations (SOP’s) as […]
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 […]