GMP
Reaching the world with EU-GMP natural psilocybin, functional mushrooms, and synthetic psychedelics.
What is GMP?
Good Manufacturing Practice (GMP) describes the minimum standard that a medicine manufacturers must meet in their production processes.
Optimi produces at an GMP level, meaning our products are eligible to be sold in the European Union (EU).
The European Medicines Agency coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at the EU level.
GMP requires that medicines:
are of consistent high quality;
are appropriate for their intended use;
meet the requirements of the marketing authorization or clinical trial authorization.
Optimi is the largest supplier of natural psilocybin in North America, and we feel good about setting the safest and most stringent production standards in the industry.
Our Facility
Optimi’s purpose-built, 20,000 square feet of state-of-the-art, technologically advanced grow facilities are dedicated to the cultivation of safe, high-quality, GMP psilocybin, functional mushrooms. and synthetic psychedelics.
We operate under strict adherence to Health Canada, US FDA, and GMP guidelines. Our facilities and processes undergo routine audits and inspections from sponsors and regulatory authorities.
Our cultivation facility is classified as a Level 8 Security Environ with an allowance of $50 million CAD worth of product to be stored on site, making it fully compliant with any requirements under GACP, GMP, and as defined in Health Canada’s Controlled Drugs and Substances Act.
We are fully licensed by Health Canada to grow and possess a quota of up to 5,000kg of dried psilocybin mushrooms – the equivalent of 10kg of psilocybin – and 100g of psilocin.
To sell Optimi products in Europe, the European Medicines Agency (EMA) requires manufacturers to comply with full Good Manufacturing Practice (GMP) no matter where in the world they are located.
“Health Canada’s message sets the right tone, right standard, and right policy when it comes to building a sustainable industry backed by hard, evidence-based, science-driven clinical research that is paramount to the health and wellbeing of Canadians.”
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