Quality & Compliance
Designed for EU-GMP from Blueprint
Every element of the facility design, processes, and quality systems has been engineered from blueprint to meet European pharmaceutical manufacturing standards — not retrofitted.
Compliance is not an afterthought at Highveld Farms. Every element of the operation — from greenhouse design to post-harvest processing protocols, quality documentation to personnel training curricula — has been architected to satisfy the most rigorous pharmaceutical standards in the world.
Certification Roadmap
A structured pathway from national licensing to full European pharmaceutical compliance
Stage 01
SAHPRA Section 22C(1)(b) Licence
Licence application pathway for authorisation from SAHPRA to cultivate, process, and export cannabis for medicinal and research purposes. Regulatory groundwork underway with CCB (Cannabis Compliance Bureau) as regulatory partner. Formal application to be submitted upon facility completion — SAHPRA requires an inspectable site for licence issuance.
Significance
The SAHPRA licence is the gateway requirement. All regulatory groundwork is in progress — CCB helped SAHPRA develop the licensing framework. Licence issuance requires a completed, inspection-ready facility.
Stage 02
GACP Compliance
Facility design and cultivation SOPs are being developed to GACP standards from inception. Full compliance to be demonstrated once the facility is constructed, operational, and inspected.
Significance
GACP compliance is a prerequisite for EU-GMP certification. All SOPs, documentation, and facility design elements are being engineered to GACP requirements — formal compliance confirmation follows facility construction and operation.
Stage 03
EU-GMP Certification
European Union Good Manufacturing Practice certification — the gold standard for pharmaceutical manufacturing recognised across all EU/EEA member states.
Significance
EU-GMP certification enables direct market access across Germany, France, Poland, and other European pharmaceutical markets without additional country-level manufacturing approvals.
Stage 04
ICH Q7 Guidelines
International Council for Harmonisation guidelines for Good Manufacturing Practice of Active Pharmaceutical Ingredients — applicable to botanical APIs.
Significance
ICH Q7 alignment ensures that Highveld Farms’ active pharmaceutical ingredients meet harmonised international quality standards accepted by regulators worldwide.
Stage 05
European Pharmacopoeia Compliance
Conformance to monographs and general methods published in the European Pharmacopoeia (Ph. Eur.) for cannabis flos and related preparations.
Significance
European Pharmacopoeia compliance ensures product specifications meet the legally binding quality requirements for pharmaceutical products sold across Europe.
Quality Assurance
Pharmaceutical-grade controls at every stage of production
The quality management system is designed to span the entire production lifecycle — from raw material intake through cultivation, harvest, analytical testing, and final packaging. Each checkpoint will be documented, reviewed, and traceable.
All inputs — from propagation material to nutrients and substrates — undergo rigorous incoming quality checks before entering the production cycle.
8
QA Checkpoints
40+
Individual Tests per Batch
100%
Batch Traceability
Every
Batch Documented
Regulatory Landscape
From South African licensing to European market access
Pharmaceutical cannabis reaching European patients must pass through a structured regulatory chain. Each stage represents a distinct compliance gate — and Highveld Farms is engineering its operations to satisfy every one.
SAHPRA
National Licensing
- ◆Section 22C(1)(b) cultivation licence
- ◆Export permit authorisation
- ◆Ongoing regulatory inspection
GACP
Agricultural Compliance
- ◆Good Agricultural & Collection Practices
- ◆Documented SOPs for all activities
- ◆Prerequisite for EU-GMP
EU-GMP
Manufacturing Standard
- ◆Good Manufacturing Practice certification
- ◆Quality Management System
- ◆Facility qualification (DQ/IQ/OQ/PQ)
Market Access
European Distribution
- ◆Country-specific import licences
- ◆Wholesale distribution authorisation
- ◆Pharmacopoeia compliance
SAHPRA
National Licensing
- ◆Section 22C(1)(b) cultivation licence
- ◆Export permit authorisation
- ◆Ongoing regulatory inspection
GACP
Agricultural Compliance
- ◆Good Agricultural & Collection Practices
- ◆Documented SOPs for all activities
- ◆Prerequisite for EU-GMP
EU-GMP
Manufacturing Standard
- ◆Good Manufacturing Practice certification
- ◆Quality Management System
- ◆Facility qualification (DQ/IQ/OQ/PQ)
Market Access
European Distribution
- ◆Country-specific import licences
- ◆Wholesale distribution authorisation
- ◆Pharmacopoeia compliance
Mutual Recognition & Market Access
EU-GMP certification from an EU/EEA-designated inspectorate is recognised across all member states through the Mutual Recognition Agreement (MRA) framework. This means a single EU-GMP certification will enable Highveld Farms to supply pharmaceutical-grade cannabis to licensed distributors and importers across the entire European market, without requiring separate manufacturing approvals in each country.
Individual countries maintain their own import licensing requirements, but the manufacturing quality standard is harmonised — dramatically reducing the compliance burden for market entry across multiple European territories.
Target Markets
How compliance enables access across key European territories
Germany
Europe’s largest medical cannabis market. Imports of pharmaceutical-grade dried flower are regulated through the Federal Institute for Drugs and Medical Devices (BfArM).
Access Pathway
SAHPRA export permit + German import licence + EU-GMP compliance
France
Expanding medical cannabis access programme administered by ANSM. Requires EU-GMP certified product and compliance with French pharmaceutical import regulations.
Access Pathway
EU-GMP certification + ANSM authorisation + French import licence
Poland
Growing medical cannabis market regulated under the Office for Registration of Medicinal Products. Accepts EU-GMP certified imports via licensed pharmaceutical wholesalers.
Access Pathway
EU-GMP certification + Polish wholesale distribution licence
United Kingdom
Regulated under the MHRA with GMP requirements for medicinal cannabis. Imports require a Home Office licence and must meet UK-specific pharmaceutical standards.
Access Pathway
MHRA GMP + Home Office import licence + UK wholesale dealer licence