Marijuana Business Magazine March 2019

Marijuana Business Magazine | March 2019 100 The first step in becoming GMP-certified is called a gap assessment. It involves assessing what your quality-management system currently involves and what else is necessary, depend- ing on which GMP certification you’re seeking. “You’re looking at what is missing to bridge the gap between (Good Production Practices, or GPP) and GMP, which is the typical scenario in Canada,” Lahnakoski said. The gap assessment then allows you to prepare an implementation timeline, and that can vary from company to company. This also is the step where you will determine if it will take you six months to reach GMP certification, or perhaps a year or more. Gap Assessment Update Documentation High-level documentation needs to be created. Most companies don’t have a master validation plan, a quality manual or a site master file. Those are high-level documents that describe the entire company and how it runs, and they’re required to be submitted to the competent authority—whether that’s the Federal Institute for Drugs and Medical Devices in Germany, Health Canada or the U.S. Food and Drug Administration. Update SOPs Keep in mind your company may need to update dozens or perhaps hundreds of standard operating procedures (SOPs). Typical producers can have between a few dozen and 200-plus SOPs. Generally, they all need to be updated for GMP compliance, even if that means updating the regulatory references within the SOPs. Add Missing Programs In the case of licensed Canadian companies, which must follow Good Production Practices (GPP) standards, programs for GMP that are not in GPP need to be implemented. Key programs include validation and stability. A stability program for your products establishes an expiration date. That’s not a requirement for GPP—considered a lower level of quality assurance—and it can be a time-consuming, data-driven process. “If you’re doing a stability program and you want a one-year expiry, you need to test the products for a year. Put it in the chamber and take it out every few months and test it,” Lahnakoski said. “It’s not something you can implement over- night. You need to generate data before the inspector comes in.” The length of the stability program usually depends on what your importer wants for an expiry date. “If you’re working with an importer who says they don’t want short-dated product and wants a six-month date on the product, you’re going to have to gen- erate that much data,” Lahnakoski said. Is it possible to extrapolate data for stability programs to get an expiry date? Yes, see the ICH guideline for that. After implementing GMP, and all your new programs and updated SOPs, it’s time to run with those systems for a number of months to demonstrate that you’re functioning as a GMP-compliant company. Prove It Dutch cannabis producer Bedrocan adheres to EU-GMP, which applies to medical producers in the European Union. Photo courtesy of Aurora Cannabis Going Global? Join the GMP Parade