GMP Certification Explained

What is GMP?

The U. S. Food & Drug Administration (FDA) is the federal agency responsible for regulating the manufacturing process of food, drug, cosmetic, and dietary supplements. In order to help regulate the supplement industry, the FDA has established a set of guidelines called "Good Manufacturing Practices (GMP)" for manufacturing, packaging, holding, and labeling dietary supplements. These guidelines or practices can be found in the Code of Federal Regulations Title 21 part 111, often referred to as 21 CFR.

Additionally, the 1994 Dietary Supplement Health and Education Act (DSHEA) regulates dietary supplements more like food than drugs. According to DSHEA, all supplement manufacturers are personally responsible for the purity and safety of supplement ingredients and that claims made on packaging (or in advertising) are substantiated by adequate scientific evidence.

To enforce GMP regulations, the FDA monitors:

  • Dietary supplements’ product information given on product labels, package inserts, or online marketing for accuracy and appropriate claims;
  • Consumer reported adverse events;
  • Safety Literature;
  • Random laboratory analysis of marketed supplements to determine if product contents match the nutrition information on the label.

When problems are detected with a dietary supplement, the FDA investigates with facility audits and third-party laboratory analysis.

Third-Part GMP Certification Programs

It is important to note that although the FDA enforces GMP from time to time when problems arise, the FDA does not administer a certification program to ensure manufacturers are complying with GMP at all times.

Since there is no FDA GMP certification or accreditation program to acknowledge GMP compliance, how can you know if Primal Pharm or any other supplement manufacturer is in compliance for the purity, quality, and safety of their products? 

To put our customer's minds at ease, Primal Pharm has partnered NSF International (the gold standard in GMP certification and customer safety) for supplement manufactures to inspect our manufacturing facilities and products to ensure we are in compliance with FDA GMP.

These private companies' certification programs require:

  1. Audits of the manufacturing facility for conformity to GMP requirements, including proper documentation, training, quality control measures, equipment cleaning, and testing.
  2. Third-party testing of raw ingredients and manufactured products for product purity, quality, and safety. These analyses also include testing for banned ingredients and determining if the supplement’s contents meet labeling claims.

We know customer service is the origin of our success. As such, we happily answer all potential clients' questions and concerns. If we do not manufacture or package what you want, we will gladly refer you to a trusted manufacturer who does. Contact us today.