GMP or CGMP (Current Good Manufacturing Practices) are FDA regulations for supplement manufacturers. They ensure ingredient consistency and prevent contamination, deviation, error, and failure.
Whether you’re a competitive athlete seeking supplements free of banned performance-enhancing substances or simply someone who wants to boost their health, choosing cGMP-certified products is essential. Here are a few facts on GMP certified supplements:
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Identity Verification
The FDA doesn’t give supplements their GMP approval; independent groups like NSF International administer this program. These organizations verify that a supplement manufacturer has the methods and facilities to produce quality products and then register these manufacturers with the FDA.
Then, manufacturers can use a GMP certification mark to inform customers that their supplements are produced in a compliant facility. In addition, they must disclose their manufacturing records, product complaints procedures, and quality control protocols.
Potency Verification
GMP guidelines established by the FDA outline strict requirements for companies producing dietary supplements. These regulations cover every aspect of the manufacturing process, including ensuring that the product is safe, pure, and effective. With a comprehensive potency verification program, producing a supplement that consistently elicits a clinical response is easy.
Passing an audit and inspection gives a manufacturer the right to display a “cGMP” seal on its products. This does not mean that the FDA certifies or approves the product, as it is illegal for them to do so. Instead, the seal indicates that the manufacturer complies with FDA regulations.
Purity Verification
While dietary supplements aren’t held to the same stringent regulations as pharmaceutical drugs, manufacturers must follow what’s known as Current Good Manufacturing Practices or CGMPs. These systems ensure processes and facilities’ design, monitoring, verification, and control. This help keeps contamination, ingredient deviation, and errors from occurring during production.
CGMPs help ensure you get the ingredients listed on the supplement facts label and nothing else. These regulations also ensure that the strength, concentration, and weight of ingredients are accurate, as well as that they are consistent.
A company must pass an annual on-site facility audit to be GMP certified. USP establishes public standards that ensure the identity, strength, quality, and purity of medicines, dietary supplements, and food ingredients. Their work is guided by scientific data and verified by their volunteer experts.
Third-Party Testing
The FDA strictly regulates the supplement industry, but much information can get lost in translation. This is why companies wishing to promote their compliance with the law have to go through a third-party audit that can provide an objective and fresh set of eyes on their company’s production facility.
For example, USP Verification Services is a highly recognizable third-party auditing organization that can certify that products contain what they say they do on the label, are made in clean and safe facilities, and don’t have contaminants like lead or mercury. The USP verification program currently focuses on vitamins and minerals.
NSF International developed the first GMP certification program specifically for dietary supplements, and they offer both product/ingredient and facility GMP certifications. NSF’s GMP programs also verify that a manufacturer is producing their products following the FDA guidelines. These programs are a great way to show consumers that you can trust the ingredients and quality of your product.
