GACP & GMP supplier audits
Know your supplier before the first batch ships
On-site GACP and EU-GMP audits of medical-cannabis cultivation and processing facilities — structured, evidence-based and documented so that your QA can decide: approve, approve with conditions, or reject.
For pharma companies, importers, pharmacies, medical-cannabis distributors and investors
- cannabis producers pre-qualified worldwide
- ~40
- on-site GACP/GMP audits of cultivation and processing facilities
- 10
- audit countries so far
- PT · DE · CA
- companies advised along the value chain
- 45+
Why audit
A certificate is a snapshot. The facility is the reality.
When you import or distribute medical cannabis, the quality risk of your supplier becomes your risk. A desk review of certificates and CoAs does not show how the facility actually works on a normal production day.
-
Rejected batches and recalls
Mould, foreign matter or out-of-spec results discovered after import cost the batch, the time on the market and trust with pharmacies and patients.
-
Import and qualification requirements
As importer or distributor you have to show that your supplier has been qualified — with traceable evidence of GACP-compliant cultivation and GMP-compliant processing.
-
Quality variance between batches
Genetics, climate control, drying and handling decide whether batch ten still matches the sample you approved. Only an on-site view shows whether the process is under control.
-
Investment and supply decisions
Before you sign a supply contract or invest in a producer, you need an independent, technical view of infrastructure, quality system and the people running it.
Audit scope
What I assess on site
The scope follows the relevant guidelines — GACP for cultivation and primary processing, EU-GMP for processing, packaging and release — and is agreed with your QA before the audit.
01 Quality system
- QMS structure, document control and records
- Deviations, CAPA, change control and complaints
- Responsibilities, qualification and training of staff
- Supplier management, specifications and release
02 GACP · cultivation
- Genetics, mother plants and propagation
- Growing media, water, fertilisers and plant protection
- Climate control, HVAC and environmental monitoring
- Harvest, drying and curing conditions
03 GMP · processing
- Hygiene zones, people and material flow
- Equipment, cleaning and maintenance
- Trimming, packaging and labelling
- Storage, batch documentation and traceability
04 Product quality
- Visual and microscopic flower assessment
- Trichomes, mould, pests and foreign matter
- Consistency with specifications and CoAs
- Sample retention and testing strategy
Procedure
Five steps from questionnaire to supplier decision
- 1
Pre-qualification
Structured qualification questionnaire and first technical assessment. Filters out unsuitable suppliers before anyone books a flight.
- 2
Document review
Licences, certificates, QMS documents, SOPs, batch records and CoAs are reviewed in advance. Open points go onto the audit agenda.
- 3
On-site audit
Walk-through of the facility, interviews with the responsible persons, record checks, photo and video documentation and microscopic flower assessment.
- 4
Report & CAPA
Audit report with graded findings, completed checklists, evidence and a CAPA list — plus a clear recommendation for your supplier decision.
- 5
Follow-up
Review of the supplier's CAPA plan and evidence of implementation. On request, a follow-up audit or regular re-qualification.
Deliverables
What you receive
Every finding is documented so that your QA, your Qualified Person or your investment committee can follow it without having been on site.
-
Audit report
Summary, scope, graded findings and a clear recommendation.
-
Completed checklists
Structured GACP/GMP checklists as audit trail for your supplier file.
-
Photo and video evidence
Visual documentation of infrastructure, processes and findings.
-
Microscopic flower assessment
Trichomes, mould, pests and foreign matter — assessed under the microscope.
-
CAPA list
Corrective and preventive actions with priority, owner and deadline.
Track record
Audit experience, not theory
- 2023
Supplier qualification & GACP/GMP audits for STADA Arzneimittel
Project lead (via Corellia GmbH): pre-qualification of ~40 cannabis producers worldwide and on-site audits of 10 cultivation and processing facilities in Portugal, Germany and Canada — quality systems, production processes, infrastructure and product quality.
- 2021 – 2023
EU-GMP quality systems at Cannavigia
First employee and product owner of a compliance and track-and-trace platform. Built complete EU-GMP QMS for Speropharm (Switzerland) and Luxacan (Zimbabwe), QMS advisory for PhytoVitality. Quality-system work reviewed with Luis Meirinhos-Soares, former Head Inspector GACP at Infarmed (Portugal).
- 2021 – 2024
AvaGro / Avacare, Namibia and Zimbabwe
Supplier qualification and technical assessment; planning of a GMP-compatible production facility and a plant-tissue-culture lab.
- 2016 – 2018
IT internal audit, Schwarz Dienstleistungen (Lidl/Kaufland)
The foundation: controls, structured assessment and audit-proof documentation.
Your auditor
Lorenz Minks
I run Research Gardens as a one-person consultancy from Küsnacht, Switzerland. You work directly with me — from the questionnaire to the final report, without hand-offs to junior staff.
I studied horticultural sciences and business informatics, ran a 1-hectare outdoor CBD cultivation and started my career in internal audit. That combination lets me read a grow room and a batch record with the same precision.
In the German industry I serve on the board of the BVCW and coordinate the BCAv, where I lead the working group on risk minimisation and product safety.
FAQ
Frequently asked questions
What is the difference between a GACP and a GMP audit?
GACP (Good Agricultural and Collection Practice) covers cultivation, harvest and primary processing of the plant. EU-GMP covers the subsequent processing, packaging, storage and release of the medicinal product. Where exactly the line sits depends on the product and the competent authority. Most cannabis suppliers need both views — I audit them in one visit.
How long does an audit take?
It depends on the size of the facility and the agreed scope. After the pre-qualification and document review you receive a concrete agenda for the on-site days and a fixed offer.
In which countries do you audit?
Worldwide. Previous on-site audits took place in Portugal, Germany and Canada; further projects in Namibia and Zimbabwe. Audits are conducted in German or English.
Can the audit be done remotely?
Pre-qualification and document review work remotely and are a sensible first filter. Infrastructure, hygiene and product quality can only be judged reliably on site — for a supplier approval I recommend an on-site audit.
How is confidentiality handled?
An NDA is signed before any documents are exchanged. The report and all evidence belong to you as the client; the supplier receives the findings and the CAPA list as agreed with you.
GACP & GMP supplier audits
Planning to qualify a new supplier?
Tell me about the supplier, the country and your timeline. In a 30-minute call we clarify scope, procedure and next steps — free of charge.