According to a 2019 report by Ellipse Analytics and CBS Austin, up to 70% of 240 bestselling CBD products available online might contain harmful impurities such as heavy metals, chemical pesticides and toxic mould, so meeting EU-GMP standards is not only critical for customer safety but also business expansion into the lucrative new European and UK markets for medical cannabis products.
In fact, it seems EU-GMP certification will become central to marketing medical cannabis – with some governments (such as Cyprus) selecting suppliers largely based on their EU-GMP compliance.
So what is GMP?
Good Manufacturing Practices (GMP) are the minimum standard that a food or medicine manufacturer must meet in its production processes, equipment and facilities to ensure that products are consistent, high quality and safe for their intended use. GMP certifications may apply to a single stage or the entire production process.
The main goal of the GMP certification in the cannabis industry is to create a “pharma-grade” cannabis product. The EU-GMP guidelines include key requirements for:
The quality system and quality control
Facilities and equipment
Validation of manufacturing and computer systems
Qualified Person (QP) batch release
Outsourced activities, including audits
Complaints and product recall
Before entering the market, all medical cannabis sold in Europe must be manufactured and tested under European GMP, along with Good Distribution Practices (GDP) certification for distribution and warehousing. GMP certification applies at a local level, which means that to work as a GMP-compliant company in the EU, a CBD manufacturer in the US or Canada would need to apply for EU-GMP certification.
CBD food supplements (rather than medication) are not required to follow GMP guidelines although many manufacturers do go through GMP certification to inspire consumer confidence to purchase.
Mutual Recognition Agreements (MRAs)
Many countries, such as the UK, Germany, Canada, the USA, Greece and Australia have legalised cannabis for medical purposes and Europe is widely expected to become the world’s largest legal cannabis market, worth up to €123b by 2028.
With each country applying different rules and regulations, trade barriers can become an issue. Mutual Recognition Agreements (MRAs) are created for GMP across different markets. For example, an MRA has been set between Canada and the EU since 2003 but since those agreements may not cover medical cannabis, many Canadian companies are now applying for EU-GMP certification.
Currently, GMP compliance and certification are not widely required but as the lines between CBD, food and pharmaceuticals blur it’s likely to become the recognised industry standard for both regulators and consumers.
Spectrum and GMP
We recognise that our systems play a fundamental role in meeting GMP requirements and, as such, they have been designed to be compliant with all relevant regulations.
Spectrum’s range of processing systems, which incorporate proprietary technology and range from laboratory through to industrial scale, are tried and tested designs, having benefited from many years of development by industry-recognised scientists and engineers.
Our partners include leading and highly-respected industry professionals from North America, including Maratek, Chemtech Services Inc. and Evolved Extraction, enabling us to provide robust, high quality, CE/CA-Marked and GMP-compliant equipment to anyone looking to enter the market or expand their operation.