“We’re Small—Do We Really Have to Follow All the GMPs?”
Summary (Key takeaways)
Yes, but “scaled” doesn’t mean “skipped.” FDA expects every supplement brand—big or small—to comply with dietary supplement GMPs (21 CFR 111). You can scale how you comply; you shouldn’t skip core controls.
GMPs are your “solve-the-problem” toolkit. When something goes wrong (e.g., a Salmonella complaint), the only way to quickly find root cause and recover is if you’ve kept the records, samples, specs, and tests the rules require.
Know your “can’t-skip” list. Master/Batch records, specifications, supplier qualification, reserve samples, sanitation, complaint/AER intake, and truthful/substantiated labeling are non-negotiable.
Start lean, not lax. You can right-size documentation and testing for early DTC sales—but keep it audit-ready. Building this foundation pays off when you move into Amazon or retail.
Why this question keeps coming up
You’re bootstrapping. Cash is tight. It can feel like GMPs were written for companies with labs and teams. Fair. But the purpose of GMPs is practical, not bureaucratic: they make it possible to find, fix, and prevent problems—fast—while protecting your brand and customers.
Here’s a simple way to see it.
The “solve for X” view of a real issue
Imagine a customer reports a Salmonella illness and FDA asks you to investigate. You’re solving for X = root cause. Without the GMP building blocks, every variable in the equation is missing:
A — Master Manufacturing Record (MMR): the “intended recipe” and steps.
B — Batch Production Record (BPR): what actually happened (who, what, when, how much).
C — Material release/CoAs: how you qualified and released each incoming ingredient.
D — Reserve (retention) samples: sealed evidence you can test to verify/defend.
E — Sanitation & environmental controls: cleaning logs, pest control, corrective actions.
If A, B, C, D, or E are unknown, you can’t prove where contamination came from or that you’ve prevented a repeat. Regulators—and customers—won’t accept guesses. That’s the business case for GMPs.
The “can’t-skip” core (even when you’re small)
Use this as your non-negotiable checklist:
Supplier qualification
Identify your actual manufacturer (not just a broker).
Verify registration, relevant certifications, and basic quality programs.
Specifications (finished product + incoming materials)
Identity, purity, strength (label claim), composition, and appropriate micro/chemical limits.
Methods and acceptance criteria defined up front.
MMR & BPR
One MMR per product/version.
A complete BPR for every lot you produce (dates, operators, equipment, yields, deviations, sign-offs).
Testing & release
Identity test of each ingredient; appropriate micro and potency testing on the finished product; add heavy metals or others where risk warrants.
Documented review and quality release before shipping.
Reserve samples
Keep reserve samples for each lot of packaged product (and components as applicable) for the required time window.
Sanitation & allergen control
Written cleaning procedures, logs, and verification; allergen segregation/labeling controls.
Labeling & claims
Correct Supplement Facts, firm info, lot coding; only truthful, substantiated claims (and use the structure/function disclaimer where applicable).
Complaints, adverse events & recall plan
Intake/triage process, serious AER reporting readiness, and a step-by-step recall playbook with lot traceability.
How to scale compliance without cutting corners
Start simple: one-page SOPs that work.
Short, clear procedures beat thick binders nobody follows. Each SOP should say who does what, when, how it’s recorded, and what to do if something goes wrong.
Risk-based testing.
Potency + basic micro on every finished lot.
Add heavy metals/pesticides for botanicals or higher-risk materials.
Use composite sampling smartly to control costs (without losing representativeness).
Right-size documentation.
MMR and spec per product; don’t rewrite the world—reuse templates across flavors/pack sizes with controlled changes.
Keep records digital (PDFs with signatures or validated e-sign) if that makes you faster and cleaner.
Plan like you’ll go retail.
A tidy document set today (specs, BPRs, CoAs, complaint log, recall plan) makes Amazon, CVS/Whole Foods, or distributor requests 10× easier later.
Common traps to avoid
“My manufacturer handles GMPs, so I’m covered.” FDA views the brand owner as responsible. Trust—but verify.
Testing only what “looks good.” Potency without micro/safety is a recall waiting to happen.
No reserve samples. You lose your strongest defense if there’s a dispute.
Claims creep. One “as effective as [drug]” line on your PDP or Amazon page can derail everything.
If funds are tight: your first 30–60 days
Draft the label now (claims, Supplement Facts, directions). This decides your specs and tests.
Write 6 lean SOPs: supplier qualification, receiving & release, manufacturing/batching, cleaning, testing & release, complaints/recall.
Create one spec & one MMR for your flagship SKU.
Pick a qualified lab and price a core test panel you can repeat every lot.
Set up lot coding & reserves (space, system, and log).
Do a mini-audit of your co-man (or your own space if DIY) with a one-page checklist.
Want help tailoring this to your product?
Signature 1-on-1 Consultations — Get a practical, brand-specific path to scaled compliance: what to test, which SOPs to start with, how to qualify your co-man, and how to keep labels/claims on-side.
SSET: Supplement Startup Essentials Training — Learn the regulatory landscape end-to-end, build a sharp market brief, and understand how to find and vet manufacturers and labs so you can scale confidently.