Free 21 CFR Part 111 Compliance Checklist

What's in This Checklist

This checklist maps every requirement of 21 CFR Part 111 — the FDA's cGMP regulations for dietary supplements — into a practical self-assessment you can complete at your facility in a half-day.

§1

Quality Management System

QC personnel, written procedures, CAPA system (§111.10–111.35)

§2

Personnel & Training

Qualifications, training program, hygiene (§111.10–111.13)

§5

Production & Process Controls

MMRs, Batch Production Records, yield reconciliation (§111.55–111.83)

§6

Component & Ingredient Controls

Receiving, supplier qualification, identity testing (§111.70–111.80)

+ 7 additional sections covering laboratory controls, finished product release, holding, distribution, complaints, and records.

Risk Scoring Guide Included

0–5 gaps: Low risk

6–15 gaps: Moderate

16–30 gaps: Elevated

31+ gaps: Immediate action

"Jared's knowledge of dietary supplement GMP regulations is exceptional. He identified gaps in our quality system we didn't know existed."

— Quality Director, Dietary Supplement Manufacturer

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Prepared by Jared Clark, CPGP, PMP, CMQ/OE

Founder, Certify Consulting Group | thegmpconsultant.com

Jared has helped 200+ companies achieve GMP certification since 2017. Certified in GMP Professional (ISPE), Project Management, and Quality Operations. This checklist reflects real-world patterns from FDA warning letters and enforcement actions.

Found Gaps in Your Quality System?

I offer a free 30-minute gap assessment call for dietary supplement companies that complete this checklist. We'll review your highest-risk gaps and discuss the fastest path to remediation.

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