What we do
- EU GMP gap assessment
- PQS design to ICH Q10
- Document hierarchy and SOPs
- Deviation and CAPA systems
- Change control
- Quality risk management
- Supplier qualification procedures
- Quality and technical agreements
- QA and QC organisation chart
- Self-inspection programme
How it runs
- 01
Gap Assessment
We measure your current system against EU GMP and record each gap in a register with its priority.
- 02
System Design
We set the document hierarchy and the QA and QC organisation chart around your activities.
- 03
Procedures
We write the SOPs with you, from deviations, CAPA and change control to quality risk management and supplier qualification.
- 04
Agreements
We draft the quality and technical agreements with your suppliers and contractors.
- 05
Training & Start
We train the people who will run each procedure and work beside them while they fill in the first records.
- 06
Self-Inspection
We set up the self-inspection programme your team runs once we leave.
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
- Selling to EU GMP buyersFrom GACP to EU GMP
- Running quality without a QA teamFractional QA
- Training your people on GMP, GACP or GDPTraining
Read more
- First-party or second-party audit: which one do you need?One looks inward at your own quality system, the other looks outward at your suppliers. EU GMP expects both, and neither can stand in for the other.Read the article
- What does draft Annex 22 allow an AI assistant to do in GMP software?Draft Annex 22 keeps generative AI out of critical GMP applications, so what an assistant may do depends on where its output ends up.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
