EU-GMP

Reaching the world with EU-GMP natural psilocybin, functional mushrooms, and synthetic psychedelics.

What is EU-GMP?

Good Manufacturing Practice (GMP) describes the minimum standard that a medicine manufacturers must meet in their production processes.

Optimi produces at an EU-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, EU-GMP psilocybin, functional mushrooms. and synthetic psychedelics. 

We operate under strict adherence to Health Canada, US FDA, and EU 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.”

– Bill Ciprick, Optimi Health CEO.

Health Canada:

On May 9, 2022, Health Canada made the following declaration regarding the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP), specifically around the “importance of drug quality and Good Manufacturing Practices (GMP).”

“Research that meets the definition of a clinical trial in the Food and Drug Regulations (FDR) is subject to Part C, Division 5, which is a set of internationally aligned regulations under the FDR that govern the sale and importation of drugs for use in clinical trials. The chemistry and manufacturing requirements set out under division 5 of the FDR require the investigational product to be of GMP quality. This means that any psilocybin product, including psilocybin mushrooms, used in a clinical trial must be manufactured according to GMP standards.”

Optimi supports this statement. Please read our response here.

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FAQs

After decades of stigma, psychedelics are emerging into the medical limelight as potential treatments for a wide variety of mental health disorders.

The Multidisciplinary Association for Psychedelic Studies, or MAPS, dates all the way back to 1986 and has helped move psychedelic science from the fringe back to the laboratories of major institutions while pioneering MDMA-assisted psychotherapy for sufferers of PTSD.

The groundbreaking research undertaken by Johns Hopkins University since the early 2000s has led investigations into the medical potential of psilocybin. The Johns Hopkins Center for Psychedelic and Consciousness Research was formally launched in 2019, and continues to conduct research into indications such as major depressive disorder and smoking cessation, among more esoteric inquiries into spiritual fulfillment.

On the other side of the Atlantic, UK non-profits and academic institutions such as the Beckley Foundation and the Centre for Psychedelic Research at Imperial College London have been responsible for landmark developments in brain imaging and psychedelic neuroscience and investigations into the use of psilocybin for depression, as well as investigating substances such as LSD and Mescaline.

All of this is only the beginning. Hundreds of clinical trials are underway into the use of psychedelic substances for mental health treatments.

Psilocybin is a Schedule III Controlled Substance under Canadian Law. It is also an approved medicine for these select few patients.

Thanks to Section 56 exemptions to the Controlled Drugs and Substances Act as well as recent amendments by Health Canada to the Special Access Program, Canadians with urgent, unmet medical needs have been allowed to access psilocybin mushrooms for medical, therapeutic and mental health purposes.

Internationally, research into psychedelic medicine for mental health treatments has never been more robust, with hundreds of clinical trials in progress.

Through the Special Access Program, health care professionals may request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable. Patients can apply to the Special Access Program through a qualified medical practitioner. For more information, please click here.

We encourage qualified medical practitioners to review the Special Access Program application process here.

Patients consuming psilocybin for therapeutic purposes are best served by a safe consistent dosage to manage treatment outcomes. A safe supply of psilocybin means that these naturally-sourced medicines are held to the same standards as all other approved pharmaceuticals, namely GMP standards.

Patients allowed to consume psilocybin by federal health authorities deserve the same level of transparency, scientific rigour and accountability in terms of the sourcing and processing of their medicine that they would receive from any other approved medication.

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

According to the World Health Organization, “Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.”

Our psilocybin products are available for medicinal use only, meaning we are legally able to supply clinical trials and Special Access Program requests.

However, we do have a robust catalog of natural functional supplements which we are selling through our nutraceutical line. Functional mushroom nutraceuticals are known for their wide range of benefits in areas such as immunity, anti-inflammation, mood, cognition.

For more information or to make a purchase, please visit www.optimilife.com

We have legitimate concerns about the message being filtered in the media which suggests black or grey market psilocybin (and other synthetic psychedelics) is Canada’s best pathway to legalization. While we support Health Canada’s policy on access through clinical trials and the Special Access Program, we do believe that more needs to be done to provide safe supply to patients, consumption sites, and trials operating through the Section 56 (1) process.

Based on current science and research, Optimi believes at minimum patients at end-of-life deserve unfettered access to psilocybin through a qualified medical practitioner. We support the Psychedelic Association of Canada’s Memorandum of Regulatory Analysis (MORA) which would provide this level of access.

Because it only takes one toxic, designer drug laced with other contaminants or microbial adulterants to put someone at risk of serious harm. Properly sourced, pharmaceutical grade psilocybin is the only way to know for sure that you’re giving your body the highest, purest, and most bioavailable form of an ingredient possible. Our psilocybin and functional mushrooms are analyzed in our state-of-the-art laboratory and sent for third party analytical testing to ensure an extremely high standard of purity and maximum absorption.

Distributors and retailers who sell these products illegally are putting Canadian consumers and their businesses at risk, and that is why Optimi is 100% committed to taking the time to cultivate, research, and test our products for when the regulatory environment improves.

Strong evidence suggests yes. Fully legal, well-funded research programs in the mid-20th century found that carefully monitored and controlled use of psilocybin may be beneficial for many psychiatric disorders, personal and spiritual development, and creative enhancement.However, after psilocybin was banned in 1970, clinical research to evaluate its medical safety and efficacy of psychedelics was effectively halted until the late 90s and early 2000s.

Today, there are dozens of studies taking place to evaluate the medical safety and efficacy of psychedelics, including psilocybin. Much of the early research did not stand up to today’s standards, as they often lacked a placebo control group or double-blinding procedures (in which neither the subject of the research nor the investigators knew whether the subject received psilocybin or placebo). Nevertheless, their promising findings have been revisited and spurred a resurgence of new, more rigorous research on the potential benefits of psychedelics as a treatment for cluster headaches, anxiety, addiction to alcohol and other drugs, depression, obsessive-compulsive disorder, as well as neuroimaging experiments furthering the understanding of its effects on the brain.

Because of the expensive and time-consuming approval process for research with Schedule I drugs, as well as the political influence of the war on drugs, research evaluating psilocybin’s beneficial uses does not receive funding from academic or government institutions, and instead relies on non-profit organizations like the Multidisciplinary Association for Psychedelic Studies, the Beckley Foundation, and the Heffter Research Institute.

Knowing the actual effects of psilocybin mushrooms, information on dosing, and resources for handling difficult experiences can help prevent dangerous situations, while enhancing their potential benefits. Mushrooms used non-medically are usually taken orally either by eating dried caps and stems, or steeped in hot water and drunk as a tea, with a common dose around 1-2.5 grams, though potency may vary regardless of the amount. Dried mushrooms are typically more potent than fresh ones. Due to the lack of quality control regulations under prohibition and the risk of consuming things growing in nature, there is potential for people attempting to pick psilocybin mushrooms in the wild to accidentally take poisonous mushrooms instead. Similarly, though also very unlikely, poisonous mushrooms are sometimes misrepresented and sold as psilocybin, and these do come with more physical risks, including fatal overdose.

Source Link: Psilocybin_Mushrooms_Fact_Sheet.pdf

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