What is environmental monitoring in cGMP for Dietary Supplements?
Environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection. Data comes from air samples, surfaces, and personnel in a clean space.
It is a significant infraction in 3rd party cGMP audit for dietary supplements.
Monitoring the production environment is critical for […]
Are you a small to medium-sized branded dietary supplement marketer? Do you have a warehouse where you store and ship nutritional supplements or functional foods to your customers?
Do You have contract manufacturers that provide you with products? Do you have cGMP standard operating procedures written and in place for your operation? Are they kept up […]
If you are a Hemp processor producing cannabinoids, your growth in this expanding market will depend upon your innovation, marketing savvy, and most critically, your unwavering commitment to making the highest quality cannabinoids and not necessarily at the lowest cost.
Due to the diversity of different cannabinoids found in the industrial hemp plant, processors will […]
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 […]
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 […]
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 […]