The 'c' in cGMP is the FDA's way of saying GMP is a living standard. A facility that meets the literal text of a 1985 GMP regulation but uses obsolete sanitation chemistry, outdated test methods, or vulnerable batch documentation is not compliant. The FDA expects manufacturers to evolve.
cGMP applies differently across product classes:
- Drugs (21 CFR 210 & 211): The original cGMP. Most rigorous. Required for OTC and Rx products. Covers everything from API qualification to stability testing.
- Dietary supplements (21 CFR 111): Established in 2007 following DSHEA. Covers identity testing of raw materials, master manufacturing records, batch records, and finished product testing.
- Food (21 CFR 117): Preventive Controls for Human Food. Layered on top of basic GMPs for food facilities.
- Medical devices (21 CFR 820): Quality System Regulation. Aligned with ISO 13485.
For private-label brands, the practical question is: does this manufacturer hold a current third-party cGMP certification appropriate for my product class? A supplement manufacturer should hold NSF or NPA cGMP. A cosmetics manufacturer should hold ISO 22716 (which is the international cosmetics cGMP equivalent). A drug manufacturer should hold a recent FDA inspection clearance and ideally an additional third-party audit.