Cannabis Facility Requirement – Health Canada
In the time period following Health Canada’s implemented approval system for cultivating and selling marijuana, several adjustments have been made to the licensing process in order to maximize efficiency and reduce backlogs. The most recent announcement has received a fair amount of attention based on its potential to exclude numerous applicants. This change involves the new requirement of a fully built site at the time of application, which is a 180-degree turnaround from the previous process in which applicants need only identify a site for their facility when applying for a license under the Cannabis Regulations. Leading up to this most recent (May 2019) change, applicants could be at any stage of development with respect to their site, and a typical applicant had secured a site but most often had not started construction on their facility.
Health Canada in their announcement of the change compared this new requirement to the currently existing Drug Establishment Licensing system for drug products, where an actual physical facility must be built (and inspected) before compliance to Good Manufacturing Practices (GMP) is confirmed. Therefore it is no surprise that Good Production Practices (GPP) based on GMP would at some point require the same state of readiness that importers and distributors of drugs products are subject to in order to be licensed.
Good Manufacturing Practices (GMP), or Good Production Practices (GPP) as they are termed in the Cannabis Regulations are based on the license holder’s ability to ensure processes are in place to consistently manufacture and store products in a manner that results in quality products that are safe to use. The required standard operating procedures, or SOP’s, in many instances have to do with the facility itself, its workflow and design, its dedicated areas for production, packaging, shipping and receiving. The best SOPs are ones that have been written with close attention to the specific attributes of the building to be used. Many operational SOPs are tied together with the facility. For example, environmental controls required to be in place will vary depending on the building in question. While one building may require thermostats to be placed at eye level, another loftier facility may require additional sensors near high shelving racks to address potentially higher temperatures. Sanitation practices and equipment maintenance procedures may also be modified based on capabilities of the facility in which they will be used, for either cannabis or drug production.
Because of the significant impact a facility has on an applicant’s ability to comply with GMP requirements, Health Canada has for many decades adopted an on-site audit approach for verification of GMP compliance of sites involved in the drug product supply chain. This approach ensures that GMP is addressed as a complete package, taking into account the unique features of the building and any potential risks related to quality of products. Since marijuana products for medical purposes may be used to alleviate symptoms of diseases in the same way that drug products are used, it would stand to reason that the facilities used for production and storage of marijuana undergo the same level of scrutiny as those facilities that import and distribute drug products in Canada. While this requirement will certainly be a roadblock for groups who have not yet begun construction of their facility, the flip-side of a reduced wait time in the license queue should be a welcome relief for sponsors who have brought their GMP and GPP commitments to their full potential at the time of submission.
