GMP Certification, Is that Important?
The U. S. Food & Drug Administration (FDA) is the federal agency responsible for regulating the manufacturing process of food, drug, cosmetic, and dietary supplements. Like pharmaceutical manufacturers, all supplement manufacturers in the USA must be registered with the FDA. Manufacturers often side-step regulations by manufacturing in facilities overseas, often with negative consequences to the public's health due to contaminants found in products.
For those established in the USA, The FDA has established current Good Manufacturing Practices (GMP) for manufacturing, packaging, holding, and labeling dietary supplements. These 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, supplement manufacturers are responsible for the purity and safety of supplement ingredients and that claims made on packaging or in advertising are substantiated by adequate scientific evidence.
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.
FDA GMP Requirements
The FDA enforces GMP in 21 CFR 111 to assure quality standards are met in the proper design, monitoring, and control of pharmaceutical production by regulating the supplement manufacturer’s physical plant, equipment, personnel training, production processes, quality control systems, packaging and labeling, holding and distribution systems, supplement returns, and documentation and record-keeping.
Testing is part of the FDA GMP quality system and includes; identity testing of incoming materials and micro testing to rule out undesirable organisms. Additional testing may be required depending upon the substances in question. These regulations assure consumers of the identity, strength, quality, and purity of the produced dietary supplements and drug products.
FDA Audits Dietary Supplement Manufacturers
The FDA randomly audits supplement manufacturers and targets any manufacturer with filed complaints. When auditing, the FDA looks for facilities in good condition with properly maintained and calibrated equipment, fully trained and qualified employees, reliable and reproducible processes, and clear and complete documentation.