cGMP (Good Manufacturing Practices) Compliance: The Vital Quality Pillar for Dietary Supplements
Regulatory compliance in the dietary supplement industry can be daunting for emerging manufacturers. With over 1500 inspections conducted by the FDA last year (2024), the need for guidance and support is evident.
To find a specific FDA 483 observational report, one must file a FOI […]
Here are the major requirements.
Leadership
Production Team Taking Ownership of the Rules
Quality Assurance Team enforcing the Regulatory Code
Ongoing cGMP training
The leader is responsible for driving the process, and it falls under the responsibility of the QA/QC team. It can often be a challenge to get the production team members on board, and […]
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 […]
Part 1 of a series. Attaining cGMP status requires dedication to five (5) essential components:
Discipline to detail and performance among all personnel. (2) Ongoing cGMP training with units involved in the manufacturing processes. (3) A leader/driver knowledgeable and proficient in the code’s documentation requirements and physical management as outlined in current CFR 21 parts […]
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 […]
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 […]
