How often should I run through this checklist?

At minimum, annually for your product review requirement (111.535). In practice, every time you onboard a new product, switch manufacturers, or change a significant process. Smart brands run it quarterly as part of internal audit.

Does this apply to contract manufacturers too?

Yes and no. Your CM is responsible for items 8-13 (in-process) and the physical manufacturing environment. YOU as the brand owner are responsible for items 1-7, 14-20, 21-27, and 28-33. The responsibility is shared, but your liability as the brand owner covers everything.

What if I'm too small to do all of this?

21 CFR 111 doesn't have a size exemption for GMP requirements. There is a small business exemption for some labeling requirements, but not for GMP testing. The FDA has cited and fined operations with fewer than 5 employees. The regulations apply at unit one.

Can I adapt this checklist for my specific product?

Absolutely. Some items won't apply (disintegration testing only applies to tablets and capsules; not powders or liquids). If a line item genuinely doesn't apply to your product, document WHY it doesn't apply rather than leaving it blank. A blank item looks like a gap to an investigator.

What's the difference between this and the full 21 CFR 111 code?

This checklist covers the testing, QC, and documentation requirements. It does NOT cover: facility requirements (Subpart D), equipment (Subpart E), production and process controls (Subpart J except as relates to testing), packaging and labeling (Subpart L), or holding and distribution (Subpart M). For a complete GMP program, use this testing checklist alongside a full 21 CFR 111 compliance review.

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21 CFR 111 GMP Compliance Checklist — Free PDF Download

7 min read Updated June 9, 2026

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)