For branded Dietary Supplement Marketers, there are essential requirements outlined in CFR 21 part 111 of the current Good Manufacturing Practice (cGMP) code that they must adhere to. These regulations encompass various aspects of production, quality control, and documentation. Engaging a knowledgeable professional can significantly enhance transparency throughout the compliance process, facilitating the creation of […]
Smaller and emerging dietary supplement manufacturers face challenges in seeking their way to cGMP certification. I understand this well. As a Quality Management Systems specialist, our planned monthly virtual meeting with the leadership team is often postponed. And if you are a manufacturer, you are well aware of the reasons.
Most often, it is simply that production […]
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 […]
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 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 […]
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 […]
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 […]
