Marijuana Business Magazine March 2019

Marijuana Business Magazine | March 2019 98 Determine Your Goal Grubb says the first step is estab- lishing your objective. “Why do you want GMP? Is it to sell to Europe? Is it to supply the drug companies and be an API supplier? Is it only for marketing purposes?” he said. After establishing an objective, it is more apparent which GMP certification your company should pursue. Karina Lahnakoski, vice president of quality and regulatory at the Ontario, Canada, consulting firm Cannabis Compliance, said most Canadian companies are pursuing EU-GMP, which applies to medical products in the European Union. “Many of the countries coming onboard (with medical can- nabis laws) are in the EU and therefore accepting the EU-GMP standard. It is also likely that meeting the EU-GMP standard means you will conform to GMP production practices put in place by other countries coming online, as the EU standard is very high,” she said. Other GMP certifications include CGMP in the United States and Canada’s Guide-104 GMP and ICH-GMP. The latter, which stands for International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, is not commonly used in the medical cannabis industry. CGMP in the United States, EU-GMP in Europe and Guide-104 GMP in Canada are effectively the same thing. But agencies in respective jurisdictions administer certification, and they’re generally applicable for businesses only for the jurisdictions where they are certified. So, if you want to manufacture drugs or active pharmaceutical ingredients in Canada, you need Guide-104 GMP. If you want to want to sell medicine in the European Union, your facility needs EU-GMP certification. Following are some of the key steps to GMP certification, according to Lahnakoski. Karina Lahnakoski is vice president of Cannabis Compliance in Ontario. Courtesy Photo Bill Grubb is vice president of Noramco. Courtesy Photo Noramco, which produces synthetic cannabinoids, has the U.S. version of Good Manufacturing Practices certification. Courtesy Photo