A COA is the paper trail that proves your product is what you say it is. Every raw material lot should have a COA. Every finished product batch should have a COA. Without COAs, you have no defensible basis for label claims and no recall traceability.
What a complete finished-product COA includes:
- Product name, batch/lot number, manufacturing date, expiration date
- Identity confirmation (the active is what you say it is)
- Potency (active ingredient at labeled dose, ± acceptable variance)
- Purity (no unexpected contaminants)
- Heavy metals (lead, cadmium, mercury, arsenic) within USP <232> / California Prop 65 limits
- Microbiology (total aerobic, yeast/mold, E. coli, Salmonella, Staph aureus)
- Physical properties (weight, dissolution, pH, viscosity, color)
- Test methods used and labs that performed testing
- Signature of qualified quality personnel and date
The critical distinction: in-house COA vs third-party COA. An in-house COA is produced by the manufacturer's own lab. A third-party COA is produced by an independent lab (Eurofins, Microbac, NSF, Alkemist Labs). For high-stakes claims (USDA Organic, NSF Certified, Prop 65 compliance), third-party COAs are the standard. For routine batch release, in-house COAs are acceptable if the manufacturer's lab is qualified.