Marijuana Business Magazine March 2019

March 2019 | 97 Going Global? Join the GMP Parade By Matt Lamers Good Manufacturing Practice certification is key for medical marijuana companies with international ambitions W hat do multinational medical cannabis cultivators have in common? They’ve achieved the gold standard for international quality compliance: Good Manufacturing Practice certification. GMP, as it is commonly known, is a codified set of rules and regulations that ensure the quality, safety and efficacy of a drug. It covers all aspects of the production process and is audited and certified by regulatory agencies. Canadian multinational cannabis firms eager to plant their flags in burgeoning international medical markets are racing to have their facilities GMP certified. Put simply, GMP certification is generally a prerequisite to the export of medical cannabis. But it’s a long, costly process and not for everyone. So, why undertake this procedure if it is so expensive and time consuming? Three reasons: • To ensure your products are compliant with the highest quality standard. • To give your product a reputational advantage. • To allow your company to conduct business across borders. Delaware-based Noramco, a specialty active pharmaceutical ingredient (API) company, has CGMP certification (the U.S. version of GMP). “By complying with GMP, the business benefit would be international opportunities and getting you to a quality standard that makes sure you don’t have business risk later on, because of the high level of rigor applied to your manufacturing process, testing, packaging, stability of the product and distribution,” said Bill Grubb, vice president of global business development at Noramco, which produces synthetic cannabinoids. Medical cannabis companies serious about their global ambitions are seeking one of the top quality-control certifications in the world, Good Manufacturing Practices (GMP). Being GMP-certified opens the door to international opportunities, mitigates risk in production processes and adds to international credibility. • There are different GMP certifications, but most Canadian companies are pursuing EU-GMP, which applies to medical products in the European Union. • Only medical cannabis from EU-GMP-certified facilities, or the equivalent, can be sold in the European Union. • EU-GMP is the same standard to which European pharmaceutical companies are held. It can apply to one step of the supply chain or the whole process. • If you don’t need it, don’t pursue it. Earning GMP certification is costly and time consuming.