GMP for cannabis and hemp extraction
Is your production room on the GMP side?
That depends on what the room is used for and who you sell to. Under GMP, it’s the facility that gets inspected, and no extractor comes with a GMP certificate of its own.
What to read before you hire a consultant
Consulting firms charge for gap assessments, facility layouts, SOPs and inspection support. The standards behind all four are public, and they’re worth reading before you pay anyone to interpret them.
- 01
Gaps
Checking each room against the published text, so you find what’s missing from your documentation before an auditor does.
Read the guide EngagementGap assessment - 02
Layout
Personnel flow, material flow and zoning get expensive to change once the slab is poured. The site is what gets inspected, and machines don’t hold GMP certificates.
Read the guide EngagementDesign consulting - 03
SOPs
The documents an inspector needs to reconstruct a batch. A poster in the break room isn’t one of them.
Read the guide EngagementSOP and quality system development - 04
FDA
How an FDA drug inspection runs, and why a state license usually doesn’t bring one.
Read the guide EngagementAudit and inspection readiness
How we source what we publish
Every regulatory statement has to cite its source
We won’t certify your site, and neither can anyone who offers to sell you a certificate. What we do is show you the regulatory text, cite it, and help you build documentation that holds up in front of an inspector. We also won’t tell you that you’re compliant. Every guide stays a working draft until a named expert signs off on it, and each one says so at the top of the page.
Read our methodologyRoom by room
Select a room to see which rules apply to it
The plan below is an example of a typical extraction suite rather than a drawing of your own facility. Use it to see which standard applies in each room before you hire anyone.
5 / 7 · inspector’s route
The same rooms, against the regulations
Harvest can stay agricultural, while extraction is manufacturing
Who do you sell to?
Annex 7 sets the boundaryDry / millDrying and cutting fall on the boundary between GACP and GMP. What brings them under GMP is the material’s intended use as an herbal medicinal product, rather than anything about the equipment.
Production roomExtractionExtraction toward an active substance is manufacturing, and it falls under EU GMP Part II. It’s the site that gets inspected, and the extraction equipment is not certified.
Farm sideGrowing, harvesting and collecting are agricultural practice. At this stage the material is still a crop.
The boundaryDrying and cutting can fall on either side. Jurisdiction and intended use decide which, and this step is where labs tend to get caught out.
Production sideExtraction and processing toward an active substance happen here, in the production room.
What an inspector looks at · 01
Cleaning
An inspector looks at the welds and jackets, and at whether the vessel can be washed without leaving anywhere for dirt to hide. However good the surface finish, it isn’t a certificate.
Facility design guideThe guides
If you run production rooms, read the guides in this order
- 01GACP to GMPWhere cultivation ends and manufacturing beginsHow an extraction lab’s activities divide between farm practice (GACP) and EU GMP manufacturing, and where the production rooms fall in between.
- 02ExtractionWhich GMP rules apply to an extraction facilityThe same room, solvent and extraction equipment fall under different obligations depending on what the extract will become. That question comes first, before any equipment decision.
- 03Annex 7EU GMP Annex 7, explained for cannabis processorsWhat the EU annex on herbal medicinal products expects of your premises, equipment and documentation once your work counts as manufacturing.
- 04ICH Q7ICH Q7 and cannabis-derived APIsHow the international GMP guide for active pharmaceutical ingredients applies to cannabis-derived ingredients when they are APIs, alongside EU GMP Part II.
- 05JurisdictionsUS cGMP, EU-GMP and state cannabis rules comparedWhat each set of rules is for, and why a state cannabis license doesn’t answer a GMP question.
- 06Facility designDesigning a facility around GMP requirementsMaterial and personnel flows, zoning, and the layout decisions that get expensive once the slab is poured, including why equipment is not “GMP certified.”
- 07DocumentationHow GMP documentation is organizedThe records that have to exist so an inspector can reconstruct what happened in your production rooms.
- 08FDA inspectionHow an FDA drug inspection worksThe Investigations Operations Manual, Compliance Program 7356.002, Form FDA 483 and the six systems, and why a state cannabis license isn’t that kind of inspection.
Advisory
Have a specific room or process in mind?
Tell us what you make, where you sell it and what you already have. A person reads every intake. We won’t tell you you’re compliant, and we won’t sell you a certificate.