What we do
- GACP and GMP boundary mapping
- Supply chain step review
- Quality risk assessment to ICH Q9
- Drying and trimming readiness
- Non-EU grower qualification
- Preparation for EU buyer audits
How it runs
- 01
Supply Chain Review
We follow your material from harvest to shipment and record what happens at each step and who does it.
- 02
Boundary Mapping
We mark where GACP ends and GMP begins, reading GACP, Annex 7 and Part II of EU GMP together.
- 03
Risk Assessment
We write the rationale for that point with the ICH Q9 risk method, in a file a buyer or an inspector can read.
- 04
Drying & Trimming
We check drying and trimming against the requirements that apply to them, since a German authority has already read drying as a critical manufacturing step.
- 05
Non-EU Growers
If you buy from growers outside the EU, we qualify them against what your EU buyer will audit.
- 06
Buyer Audit Preparation
We prepare your team and your documents for the audit of your EU buyer.
Other services
- Importing flower or extracts into the EUEU GMP supplier qualification
- Auditing a supplier, a CMO or your own siteIndependent EU GMP and GDP audits
- Growing cannabis for medical useGACP cultivation compliance
- Building or fixing your quality systemPharmaceutical Quality System
- Running quality without a QA teamFractional QA
- Training your people on GMP, GACP or GDPTraining
Read more
- Where does GMP start for medical cannabis?Four EU texts pass the question to each other: how GACP, Annex 7, Part II and ICH Q9 build a defensible GMP boundary for cannabis.Read the article
- What is the future of EU-GMP in medical cannabis?The legal base is being rewritten, certificates carry less weight, and the duty to verify stays with the buyer: my reading before the PTMC panel in Lisbon.Read the article
- Who verifies GACP compliance for medical cannabis?The EMA guideline on GACP gives the check to the buyer, through regular audits of the grower’s sites, and its text describes no GACP certificate.Read the article
