21 CFR 111 GMP Compliance Checklist — Free PDF Download
This is the checklist FDA investigators use to evaluate your supplement operation. Every item references the specific CFR section. Every item matters.
Raw Material Testing (21 CFR 111 Subpart E)
- 1. Identity testing on every incoming lot of each dietary ingredient (111.75(a)(1)(i))
- 2. Identity testing on every incoming lot of each component (111.75(a)(1)(ii))
- 3. Supplier qualification documentation — you must qualify suppliers before relying on their COAs (111.75(a)(1))
- 4. Raw material sampling plan documented — how you sample, how much, from where in the lot (111.80)
- 5. Raw material specifications documented — identity, purity, strength, composition limits (111.70(b))
- 6. Raw material reject procedure — what happens when materials fail incoming inspection (111.77)
- 7. Reserve samples of each dietary ingredient lot — kept at least until finished product expiry (111.83)
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