Facility under construction
Design layout, flows, equipment, and QMS with EU-GMP logic before structural mistakes lock in cost.
EU-GMP Consultancy
EU-GMP readiness without improvisation.
We support medical cannabis producers and operators in building and reviewing quality systems, GMP documentation, batch records, Site Master File, CAPA, change control, qualification, and validation to prepare for inspections, European buyers, and regulated markets.
No certification promises. Technical evaluation of readiness status.
EudraLex Volume 4
Annex 7 · Annex 11 · Annex 15
QMS, validation, audit readiness
Self-assessment
How aligned is your operation with EU-GMP?
Six questions covering QMS, documentation, and quality control. A structured diagnostic before your first inspection or buyer audit.
6 questions, around 5 minutes
Personalised PDF report with archetype classification and gap analysis
Optional 30-minute review call with a Clear consultant
We collect your email at the halfway point. Privacy policy.
PREVIEW
Your Report
Foundation
CoverageYou
Maturity
Optimisation
Methodology
Built on real audit experience.
Based on EudraLex Volume 4 and EU pharmaceutical manufacturing directive. Clear's consultants are IRCA-qualified with direct experience across European GMP inspections for medical cannabis manufacturers.
Sample
The questions that matter.
“Do you have a formally documented Quality Management System covering all critical manufacturing processes?”
“Are your batch manufacturing records complete, legible, and retained in accordance with EU-GMP requirements?”
“Has your site undergone a self-inspection programme or mock inspection in the last 12 months?”
5 archetypes
Where you stand. What you can do.
Foundation
First stages of the compliance journey. Basic systems and documentation not yet formally in place.
Coverage
Compliance frameworks in progress, with partial implementation. Gap analysis and prioritisation are the main focus.
Maturity
Mature systems with specific gaps remaining. Targeted remediation to close priority observations.
Optimisation
Near full compliance with refinement needs. Audit readiness and continuous improvement as the next horizon.
Next steps
A report, then options.
Right after submission
- ✓Your 3-page PDF report delivered to your email
- ✓Archetype classification with detailed reasoning
- ✓Concrete next steps tailored to your position
If you want to discuss
- ✓Optional 30-minute call with a Clear consultant
- ✓No commitment, no sales follow-up unless requested
- ✓Schedule directly via Zoom Scheduler
Recognition
These six situations indicate that GMP readiness needs attention.
01
SOPs exist but lack version control, are out of date, or get applied inconsistently across the team.
02
Batch records are filled in by production but never formally reviewed or reconciled.
03
Deviations are managed informally, without root cause analysis, CAPA, or closure.
04
Qualification and validation documentation is incomplete, in draft, or missing entirely.
05
Data integrity has never been formally assessed and nobody tracks audit trail status.
06
Nobody has a clear picture of what the next competent authority inspector will examine.
The problem
GMP is proven with a quality system that withstands inspection.
Many medical cannabis operations arrive late to the problem: facility already built, production started, SOPs written quickly, partial training, incomplete batch records, open validation, deviations and CAPA managed informally.
The risk extends across documentary, commercial, regulatory, and financial dimensions: critical inspection findings, lost buyers, delayed exports, immobilised capital, teams under pressure. The gaps surface at the worst possible moment.
Inspection focus
What inspectors look at.
Competent authority inspectors assess six core areas. Each one requires documented evidence on the table.
Scope clarification
This page covers the pharmaceutical phase.
GACP covers the cultivation and harvest of the botanical raw material. EU-GMP covers what happens once that raw material enters a manufacturing environment: processing, extraction, packaging, quality control, documentation, QMS, and release.
If your operation is upstream of manufacturing, see our GACP consultancy.
Who it is for
Find your scenario.
Each starting point leads to an engagement calibrated to that specific situation.
Operating producers
Production runs but the quality system is informal. Move toward an auditable structure.
Incomplete or weak SOPs
Documents exist but lack control, training links, and connection to batch records.
Pre-inspection companies
Approaching the first EU-GMP inspection. Need a documented readiness state.
Post-inspection observations
Findings open from a previous inspection. Need a structured, defensible CAPA response.
Exporters and premium suppliers
Already exporting, but selective European buyers require stronger QMS evidence.
Regulatory framework
Four pillars of the EU-GMP system.
EU-GMP for medical cannabis is structured around EudraLex Volume 4 and its applicable Annexes. Knowing which rules govern which activity is the first step toward a defensible QMS.
What we do
EU-GMP services that turn processes into an auditable QMS.
Three areas of intervention, twelve services. We can work on a single area or run the full path to readiness.
Area A
Diagnosis
EU-GMP gap analysis
Map the current state of QMS, documentation, facility, and operations against applicable Parts and Annexes.
Site Master File review
Strengthen or build the key document describing the site, activities, QMS, and responsibilities.
EU-GMP due diligence
Risk evaluation for investors, boards, or M&A: gaps, certifiability, timelines, and cost exposure.
Area B
QMS and documentation
QMS setup or review
Structure a quality system aligned with production, QA, QC, document control, and clear responsibilities.
SOP creation and remediation
Transform generic SOPs into controlled, applicable, and trainable operating procedures.
Batch record design or review
Improve traceability, consistency, and batch review across manufacturing stages.
Deviation, CAPA, OOS
Build a system that manages quality problems in a traceable and defensible way.
Change control
Avoid unevaluated changes to processes, equipment, facility, computerised systems, and documents.
Area C
Validation and readiness
Qualification and validation
Support across equipment, utilities, processes, cleaning, and computerised systems through the validation lifecycle.
Annex 11 readiness
Review of digital systems: data integrity, access controls, audit trails, backups, periodic review, validation.
Audit readiness
Mock audit, evidence pack, team preparation, and inspector-question simulation.
Post-inspection CAPA plan
Structured response to observations and non-conformities with a defensible roadmap.
Not sure which areas you need?
The gap analysis identifies that. Start there.
How we work
From gap to readiness.
Seven steps with defined outputs at every stage. You always know where we are and what comes next.
What you receive
Twelve concrete deliverables.
Operational documentation ready for use in your specific context.
Quality system foundation
Documentation and data integrity
Inspection and validation
Authority
EU-GMP expertise applied to medical cannabis reality.
The convergence of botanical raw material, pharmaceutical processes, quality control, traceability, and regulated-market requirements demands more than generic GMP knowledge.
Frequently asked questions
Questions we hear most often.
Before facing buyers, inspections, or investors, verify the strength of your EU-GMP system.
Request a gap analysis to understand the real state of your QMS, identify critical gaps, and build a realistic path toward readiness.