Marijuana Business Magazine March 2019

March 2019 | 103 GO IT ALONE OR HIRE A CONSULTANT? Having the insight of consultants who have experienced multiple Good Manufacturing Practice (GMP) programs and inspections can be helpful to ensure best practices from across the industry are taken into consideration. There’s no question that this route gives the site a better chance to pass the inspection. But it’s not cheap. DOES YOUR COMPETITOR HAVE GMP CERTIFICATION? Want to know if your competitor has EU-GMP certification, or a different GMP certification that could be used mostly for marketing purposes? It’s no secret. Check out the EU-GMP certification database at: eudragmdp. The Canadian database is at: BRUSH UP ON MUTUAL RECOGNITION AGREEMENTS Jurisdictions have mutual recognition agreements (MRA) among them that recognize their respective GMP certifications. The caveat is those agreements don’t always cover medical cannabis, which is why Canadian multinationals are racing to get EU-GMP certification. However, mutual recognition agreements between some European countries and Australia do cover medical cannabis, if it is regulated as a medicine in the other country. That means a medical cannabis company in Australia that has GMP certification from the Australian Therapeutic Goods Administration can export medical marijuana to Europe without seeking a separate EU-GMP certification. “Applicants would be required to provide the relevant evidence to demonstrate that the medicinal cannabis product has been manufactured in accordance with the Code of GMP (or equivalent manufacturing standard) as would be applied to domestic manufacturers,” an Australian Department of Health spokesperson told Marijuana Business Magazine. – Matt Lamers Other Considerations Importer’s Audit After implementing GMP in your facility, accumulating sufficient data and demonstrating you can function as a GMP company, it is time to bring in the importer’s Qualified Person (QP) for an audit. A third-party auditor also can handle this key stage. “You’re meeting the requirements of the regulator, but you’re also in a relationship with an importer on the other side. And that importer has a Qualified Person who is responsible for releasing your product when it comes to their market. The QP will audit you and may also have their own requirements they may impose,” Lahnakoski said. “So you need to know who you’re working with, and what they need from you.” For example, some QPs won’t accept irradiated medical cannabis products, so the licensed producer has to put into place a specification for products just for that customer to ensure no irradiated products get shipped to that country. Regulator’s Inspection After the QP—or third-party auditor—is done with you, that person will call in the respective government body (called “competent authority”) for the GMP inspection. Passing the inspection is not guaranteed. The approval rate for Canadian licensed producers is less than 100%. There will always be observations to address after the inspection, and communication with the authority to close those observations in an acceptable manner. Photo courtesy of Noramco