Built to the Wrong Standard
Your state borrows from Part 111, your neighbor's borrows from Part 117, and the audit checklist keeps evolving. Teams build a quality system to the wrong rulebook — and find out at the audit, not before it.
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GMP compliance for cannabis manufacturers.
There is no federal GMP standard for cannabis — every state writes its own rules, and the strictest states now demand qualified third-party GMP audits. Extraction, testing, and batch records carry the most audit risk. We build the evidence file before the auditor does.
WHY NOW
The rules are tightening, state by state.
Cannabis GMP is no longer a nice-to-have. States are writing real manufacturing requirements — and auditing against them.
0Federal GMP standards for cannabis in the US. Every requirement comes from your state — and states increasingly borrow from 21 CFR Parts 111 and 117.
1 yearIn New York, licensed processors must pass a qualified third-party GMP audit within one year of commencing operations — tied to Part 111 or 117 by product type.
4 weeksOur flagship GMP Readiness Assessment, baselined against your state's actual rules — then we stay and execute the full validation ourselves.
WHERE IT BREAKS
The four failures behind most cannabis audit findings.
Auditors and inspectors keep finding the same gaps. Close them before your audit.
Testing Failures Nobody Saw Coming
Pesticide, heavy-metal, and microbial failures that trace back to input control and process gaps — not the lab. When a batch fails, the question is never just the test result. It's the chain behind it.
Extraction Without Validation
Extraction scaled from R&D with no documented operating ranges, no equipment qualification, no process validation. The most scrutinized step in the plant is the least documented one.
Batch Records With Holes
BPRs missing in-process checks, deviations recorded days late or not at all, packaging and labeling verification gaps. A batch record should tell the story of the batch — holes tell their own story.
WHAT WE DO
Assessment first. Then we execute the validation.
Cannabis is our first industry — and the one where the gap between "we have SOPs" and "we can prove it" costs the most. We don't just find the gaps. We close them.
GMP Readiness Assessment
Our flagship four-week engagement, baselined against your state's cannabis rules: personnel, facility and grounds, equipment, production and process controls, packaging and labeling, testing, and records.
You receive a prioritized gap register ranked by risk — and a remediation roadmap sequenced for your next audit or inspection.
Full Validation Execution
Beyond the assessment, we execute: IQ/OQ/PQ for extraction and packaging equipment, process validation with documented operating ranges, cleaning validation, and test-method support — the actual validation work, done by us, not handed back as a to-do list.
CQV for Cannabis Facilities
Commissioning and qualification for extraction suites, packaging lines, controlled environments, and utilities — qualification that reflects actual operating ranges, not vendor defaults. See our CQV service.
Quality Systems & Remediation
Batch record design that matches reality, testing programs, deviation and CAPA systems, supplier qualification — and structured response when an inspection or third-party audit goes badly. Start with the readiness assessment to find out where you stand.
THE RULES THAT CREATE THE BURDEN
What you're actually being judged against.
There is no single cannabis GMP. There are fifty state rulebooks — here are the ones raising the bar fastest.
New York
Licensed processors must maintain GMP and pass a qualified third-party GMP audit within one year of commencing operations — anchored in 21 CFR Part 111 or 117 depending on product type. The strictest audit regime in the country.
California
The state's own cannabis GMP rules (4 CCR 17207–17218) set manufacturing practice requirements independent of the federal food and drug rules — with state inspectors enforcing them.
Florida & Illinois
Florida requires Food Safety GMP inspection for medical marijuana treatment centers. Illinois incorporates 21 CFR 117 for infusers — food GMP applied to cannabis edibles and beverages.
The Federal Gap
No federal GMP standard for cannabis exists, and none is coming soon. State rules fill the void — and they keep tightening. Building to the strictest applicable standard is the only durable strategy.
QUESTIONS
Cannabis, answered.
Which GMP standard applies to my cannabis facility?
There is no federal GMP standard for cannabis in the US — it is state-by-state. Your state's rules determine the standard: New York ties licensed processors to third-party GMP audits anchored in 21 CFR Part 111 or 117 by product type, California enforces its own cannabis GMP rules (4 CCR 17207–17218), Florida requires Food Safety GMP inspection for medical marijuana treatment centers, and Illinois incorporates 21 CFR 117 for infusers. We baseline every assessment against your state's actual requirements, not a generic template.
How do we prepare for a third-party GMP audit, like New York requires?
The same way you prepare for an FDA inspection: records first, floor second. New York requires licensed processors to maintain GMP and pass a qualified third-party audit within one year of commencing operations. Our readiness assessment runs the way an auditor would — documentation, testing programs, batch records, CAPA — and the final readout includes a mock-audit debrief with the questions your team should be ready to answer.
Can you validate our extraction process?
Yes — extraction is the most scrutinized step in most cannabis plants and the least documented. We qualify extraction equipment (IQ/OQ/PQ), define and validate operating ranges, and document the process so it stands up to auditor questions about consistency, yield reconciliation, and residual solvent control.
What testing and laboratory controls do we need?
States require testing for pesticides, heavy metals, microbials, and potency — but the audit failures usually sit upstream of the lab: incoming material control, in-process sampling, COA verification, and out-of-specification handling. We build the testing program around the full chain, not just the final panel, so a failed test traces to a controlled process instead of an uncontrolled one.
We failed an inspection or audit. What now?
Speed and sequencing matter. We map each cited finding to its root cause, build the evidence your corrective-action response commits to, and order the remediation so the highest-risk findings close first. Then we execute the validation work — not just the paperwork — so the follow-up audit finds closures, not repeats.
FREE DOWNLOAD
Get the Free Checklist
Find your gaps before an auditor does.
Our free 25-point Cannabis GMP Checklist — the same questions auditors ask, as a yes/no self-check. Every unchecked box is a finding waiting to happen.
Don't let the first gap be found under pressure.
Start with a free readiness call — cannabis focused. We'll walk through your top 3 GMP risks and give you an honest fit assessment. Confidential, no pressure.