01 · GACP to GMP · start here · working draft
Where cultivation ends and manufacturing begins
How 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.
Reference and advisory
- GMP glossarySeventy-two GMP terms, defined in plain English. A definition explains what a term means; it can’t tell you whether a particular site complies.
- Standards indexThe rulebooks that apply from crop to medicine, in the order you meet them: cultivation, the active substance, then the finished product.
- Advisory servicesGap assessments, facility design reviews, SOP development and inspection readiness. We don’t issue certificates.
Short answers to common questions
Annex 7
Jurisdictions
- Do state cannabis rules count as GMP?No.
- What is a GMP certificate?The recorded outcome of inspecting one named site. You can’t buy one.
- Which GMP applies to hemp and CBD?It depends on what the product is sold as.
- What is EU-GMP?The EU’s GMP rules, published as EudraLex Volume 4.
- GMP labs and lab accreditationTwo separate systems that often get mixed up.
- How do you verify a GMP claim?You can do it yourself, free, in four steps.
- GMP accreditation vs certificationDifferent documents from different issuers.
Advisory
- GMP gap assessmentA prioritized list of work you can budget for.
- GMP facility design consultingRooms specified from the product outward.
- SOP development and GMP quality systemsA document set written from your own process.
- GMP audit and inspection readinessA rehearsal run the way a real inspection runs.
Extraction
Facility design
- Can equipment be GMP certified?No.
- Material and personnel flowDoors, room pressures and dirty-pallet routes.
- The GACP / GMP interface on a floor planA physical boundary on the drawing.
- Contamination control strategyAn organizing model for the whole facility.
- What does GMP not require?Much of what operators are told it does.
- Grade C/D or C1D1?They measure different things.
Documentation
- What is a site master file?A description of the site, on paper.
- Change control and deviations: what’s the difference?Planned changes versus unplanned departures.
- What the grower still has to tell the manufacturerThe farm’s records still matter downstream.
- What documents should equipment arrive with?The documents a machine can come with.
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.