Extraction labs
Is your production room on the line?
GMP inspects the facility. Not the skid. No extractor carries a certificate.
Before you hire a consultant.
Gap, floor, SOPs, inspection — firms invoice these. The standard underneath is public. Read it first.
- 01
Gap
Walk the rooms against the published text. Find the missing file before an auditor does.
- 02
Floor
Flows and zoning that get expensive after the slab. Machines are not certified. Sites are inspected.
- 03
SOPs
What has to exist so an inspector can reconstruct a batch — not a poster in the break room.
- 04
Inspect
How an FDA drug inspection actually runs — and why a state license is usually not that visit.
How to read us
Every regulatory sentence has to open to a source.
We will not certify your site — and neither can anyone selling you a certificate. What we do is show you the text, cite it, and help you build a file that stands up in the room. We will not tell you that you are compliant. Every guide is a working draft until a named expert signs it — and each page says so at the top.
How a claim is allowed to existStand in a room
Click the room you actually run.
A plan of a typical extraction suite. Not your facility. Use it to see which standard is speaking before you hire anyone.
5 / 7 · inspector path
The same rooms, on the standard
Harvest can stay a crop. Extraction is manufacturing.
Who do you sell to?
Annex 7 is speakingDry / millDrying and cutting sit on the line. Intended use as a herbal medicinal product is what pulls them into GMP — not the steel.
Production roomExtractionExtraction toward an active substance is manufacturing. EU GMP Part II. The site is inspected. The skid is not certified.
Left — still a cropGrowing, harvest, collection. Agricultural practice.
The argumentDrying and cutting. Jurisdiction and intended use decide. This is where labs get surprised.
Right — productionExtraction and processing toward an active substance. That is the production room.
01 · Cleanable
The inspector looks at welds, jackets, and whether this can be washed without hiding dirt. Finish is not a certificate.
Facility designRead in this order if you run rooms.
- 01The lineWhere cultivation ends and manufacturing beginsThe activity split an extraction lab actually has to walk — farm practice on one side, EU-GMP manufacturing on the other, and the production rooms in between.
- 02ExtractionWhat the standard reaches in an extraction roomThe same room, solvent and skid sit under different obligations depending on what the extract becomes — and that is the first question, not a later detail.
- 03Annex 7The standard that draws it, in plant languageWhat the European herbal-medicines annex expects of premises, equipment, and documentation once you are manufacturing.
- 04ICH Q7When the fraction is an APIHow the active-substance guide maps onto cannabis-derived ingredients, next to EU GMP Part II.
- 05JurisdictionscGMP, EU-GMP, and state cannabis rulesWhat each document is for. Why a state license does not answer a GMP question.
- 06The suiteFacility design that follows from the standardFlows, zoning, and the layout decisions that get expensive after the slab — including why equipment is not “GMP certified.”
- 07The fileDocumentation, SOPs, and handoverWhat has to exist on paper so an inspector can reconstruct what happened in the production room.
- 08FDAHow an FDA inspection actually runsIOM, CPGM 7356.002, Form 483, the six systems — and why a state cannabis license is not that inspection.