The Federal Food, Drug, and Cosmetic Act (FDCA), signed into law in 1938, gives the FDA the authority to regulate the sale of food, drugs, and cosmetics. The regulations that guide the enforcement of the FDCA are given in Title 21 of the Code of Federal Regulation (21 CFR). In short, the FDCA states that in order for drugs to be sold in the United States, they must be manufactured according to Current Good Manufacturing Practices (CGMPs). Operating per GMPs ensures that drug products are safe for patient consumption.
GMPs cover all aspects of manufacturing, including:
- Quality unit organization
- Supplier evaluation and raw material management
- Personnel training
- Facility design
- Process validation
- Labeling and packaging
At best, navigating quality and regulatory systems is confusing and time-consuming. At worst, it can induce fear in companies and employees, deter innovation, slow down business operations, and increases costs.
Ensuring that manufacturing processes meet CGMP requirements should not be problematic. Laws are intentionally made flexible to allow manufacturers to apply GMP principles to their unique processes in a logical fashion. This is done to encourage innovation and right-sizing of quality systems. It is essential that manufacturers understand FDA guidelines in order to keep their organization operating and innovating within those guidelines.
The Kymanox team consists of engineering, business, and regulatory experts that are able to help modern medicine manufacturers navigate every part of the GMP process.