Production and Quality Control: From GACP to GMP in Medical Cannabis
- IMCI Pharmaceuticals
- Apr 10
- 2 min read
In our 3rd article on Medical Cannabis vs. Traditional Pharmaceuticals, we explore the
Production and Quality Control: From GACP to GMP in Medical Cannabis
When it comes to medical products, how they're grown, processed, and controlled is essential to ensuring safety, consistency, and therapeutic reliability. In both Europe and Israel, the production chain for medical cannabis is evolving to align with pharmaceutical standards — but it still differs from traditional drug manufacturing.
Pharmaceuticals: A Fully GMP-Compliant System
In the pharmaceutical industry, every step — from raw material sourcing to packaging — must comply with Good Manufacturing Practices (GMP). These are strict guidelines covering:
Sanitary conditions
Equipment validation
Consistency of composition
Traceability and documentation
The European Medicines Agency (EMA) enforces EU-GMP standards for all medicines in Europe. In Israel, the Ministry of Health applies similar standards, ensuring every pill or vial is chemically identical and safe for mass distribution.
Medical Cannabis: GACP + GMP Across a Two-Tiered Supply Chain
Medical cannabis is unique because it starts as a plant. This introduces challenges not typically faced in pharmaceutical production.
The process generally follows a two-tiered compliance model:
1. Cultivation — GACP (Good Agricultural and Collection Practices)
Cannabis plants are grown under GACP, a standard for medicinal herbs. GACP ensures:
Clean, controlled growing environments
Prevention of microbial contamination
Appropriate harvesting, drying, and storage methods
This stage focuses on agricultural quality and cleanliness, not pharmaceutical-grade uniformity.
2. Post-Harvest Processing — EU-GMP (or IMC-GMP in Israel)
Once harvested, any cannabis product intended for medical use — including dried flowers, oils, extracts, or capsules — must be processed under GMP standards.
In Europe, final products must meet EU-GMP requirements before reaching patients. This applies whether the cannabis is grown locally or imported.
In Israel, the IMC-GMP standard (developed by the Israeli Medical Cannabis Agency) is mandatory for all licensed processors, packaging facilities, and distributors.
This part of the chain includes:
Laboratory testing (potency, contaminants, pesticides)
Batch documentation and quality assurance
Standardized formulations and packaging
The Challenge: Consistency in a Complex Plant
Unlike synthetic drugs, cannabis contains dozens of active compounds (like THC, CBD, and terpenes), which can vary based on genetics, climate, and growing methods. Even when GACP and GMP are followed, achieving batch-to-batch consistency remains challenging — especially for whole-flower products.
This variability creates barriers to:
Standardized dosing
Clinical trials
Regulatory approvals as full pharmaceutical products
The Outlook: Pharma-Grade Cannabis, Step by Step
Europe and Israel are both moving toward complete pharmaceutical-grade control of cannabis products. Israel's export-ready infrastructure and Europe’s insistence on EU-GMP compliance are raising the global standard.
As more producers upgrade facilities and apply pharma-level processes across the entire chain, medical cannabis is steadily evolving from a plant-based remedy to a rigorously controlled therapeutic product.
