In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. Today’s topic is cGMPs — Current Good Manufacturing Practices — for dietary supplements. If you manufacture supplements, understanding Part 111 isn’t optional.
The cGMP regulations for dietary supplements are found at 21 CFR Part 111. They apply to all domestic and foreign facilities that manufacture, package, label, or hold dietary supplements sold in the United States.
Here are the core requirements. Personnel: your employees must be qualified through education, training, or experience to perform their assigned functions. You need written training records. Physical plant and grounds: your facility must be maintained in a clean and orderly condition, with adequate lighting, ventilation, and plumbing. Equipment and utensils: equipment used in manufacturing must be designed and maintained to prevent contamination of the product. Production and process controls: you must establish written master manufacturing records for each product and follow them consistently. Laboratory operations: you must test components and finished products to verify they meet your specifications for identity, purity, strength, and composition. Records and recordkeeping: you must maintain extensive records — for at least one year beyond the shelf life of the product — covering all manufacturing, testing, and quality control activities.
The biggest gaps I see in supplement cGMP programs are in documentation and testing. Many companies have the right practices but don’t document them adequately. If it’s not documented, it didn’t happen in the FDA’s eyes.
We help supplement manufacturers assess their cGMP programs and build the systems they need to be inspection-ready. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.