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Site index
Every page on the site is listed here, in three groups. The first group describes us, the publisher. The guides and the shorter question pages are working drafts: they haven’t been reviewed, they aren’t an authority you can cite, and we don’t ask search engines to index them.
About us · open to search engines
Who publishes this site
- Home
- AboutWho we are and what the site covers. A field guide, not a verdict.
- MethodologyHow we source, grade and review each regulatory claim.
- Editorial & ethicsWhat we will and won’t say, and why.
- Decimal disclosureOur commercial relationship with Decimal, stated plainly.
- OpsonaOur sister company, which makes software for regulated manufacturing.
- DisclaimerGeneral education. Not legal, regulatory, or compliance advice.
- AccessibilityWCAG 2.2 AA is our target. A target is not a certificate.
- Regulatory timelineConfirmed changes to the rules, with their dates.
- Site indexEvery page on the site, in one list.
- ContactMail goes to hello@gmpequipment.com. We keep your message so we can reply to it.
- IntakeSeven steps and thirty-one questions. A person reads your answers.
Guides · draft
The long-form guides
- GACP to GMPWhere cultivation ends and manufacturing begins
- ExtractionWhich GMP rules apply to an extraction facility
- Annex 7EU GMP Annex 7, explained for cannabis processors
- ICH Q7ICH Q7 and cannabis-derived APIs
- JurisdictionsUS cGMP, EU-GMP and state cannabis rules compared
- Facility designDesigning a facility around GMP requirements
- DocumentationHow GMP documentation is organized
- FDA inspectionHow an FDA drug inspection works
- GMP glossary
- Standards index
- Advisory services
Questions · draft
Short answers to common questions
Annex 7
- Is drying GACP or GMP?It depends on intended use.
- Where does GMP begin?It depends: at a step in the process, not at a doorway.
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
- Hydrocarbon extraction under GMPTwo regulators with different priorities.
- Ethanol extraction under GMPA reasonable choice, though not the easy one.
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.
FDA inspection
- Does the FDA inspect state-licensed cannabis labs?Usually not.
- The six systems in FDA drug manufacturing inspectionsSystems of control, rather than individual machines.
- What is a Form FDA 483?A list of observations, before any Agency decision.
Also on the site
- JournalLonger pieces on the GMP questions operators ask. Field notes, not a catalog.
- StyleguideThe site’s type, color and components, for reference.