01 · The line · start here · draft
Where cultivation ends and manufacturing begins
The 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.
- 02 · ExtractionWhat 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.
- 03 · Annex 7The standard that draws it, in plant languageWhat the European herbal-medicines annex expects of premises, equipment, and documentation once you are manufacturing.
- 04 · ICH Q7When the fraction is an APIHow the active-substance guide maps onto cannabis-derived ingredients, next to EU GMP Part II.
- 05 · JurisdictionscGMP, EU-GMP, and state cannabis rulesWhat each document is for. Why a state license does not answer a GMP question.
- 06 · The 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.”
- 07 · The fileDocumentation, SOPs, and handoverWhat has to exist on paper so an inspector can reconstruct what happened in the production room.
- 08 · FDAHow an FDA inspection actually runsIOM, CPGM 7356.002, Form 483, the six systems — and why a state cannabis license is not that inspection.
Hubs
Eleven p.m. questions
- Is drying GACP or GMP?Conditional. Intended use decides.
- Where does GMP begin?Conditional. At a step, not a door.
- Do state cannabis rules count as GMP?No.
- What a GMP certificate actually isA site record. Not a purchase.
- Which GMP applies to hemp and CBD?Conditional. Ask what it is sold as.
- What is EU-GMP?EudraLex Volume 4.
- Hydrocarbon extraction under GMPTwo authorities, one room.
- Ethanol extraction under GMPNot the easy option.
- GMP labs and lab accreditationTwo systems, often mixed.
- How do you verify a GMP claim?Yourself. Free. Four steps.
- Accreditation or certification?Different objects. Different issuers.
- Is equipment ever “GMP certified”?No.
- Material and personnel flowDoors, pressure, dirty-pallet paths.
- The GACP / GMP interfaceA door, not a vibe.
- Contamination control strategyA strategy. Not a Grade C sticker.
- What does GMP not require?Most of what you were told.
- Grade C/D or C1D1?Two axes. Not alternatives.
- The Site Master FileWhat the site is, on paper.
- Change control and deviationsTwo different folders.
- GACP → GMP knowledge transferThe farm still has to tell the plant.
- The equipment document packWhat a machine CAN carry.
- Does FDA inspect state cannabis labs?Usually no.
- The six systemsNot six machines.
- Form FDA 483Not a verdict.