In 2001, the Marihuana Medical Access Regulations (MMAR) came into force, making medical cannabis production in Canada legal for the first time [1]. Twelve years later, the Marihuana for Medical Purposes Regulations (MMPR) established the first set of regulatory requirements related to the production of medical cannabis from a quality standpoint [2]. In addition to licensed producers (LPs) being subject to the Controlled Drugs and Substances Act and the Food and Drugs Act, they were now also subject to Good Production Practices (GPP). Through the implementation of the former Access to Cannabis for Medical Purposes Regulations (ACMPR) and the enacting of the current Cannabis Regulations, these quality requirements have become the standard that LPs in Canada are held to with regards to the production of cannabis for both medical and recreational markets [3].
If you are looking to produce and sell products domestically, demonstrating how you meet GPP requirements and how they are implemented is sufficient. However, if you are looking to target international medical markets (please note that at this time the export of cannabis in Canada is only allowed for medical and research purposes), implementation of GPP in your cultivation or processing facility will not suffice and will be subject to scrutiny by inspecting regulatory bodies.
Since 2001, there has been a progressive attitude at the international level with regards to cannabis legislation. To date, upwards of thirty countries have legalized cannabis for medical purposes [4]including Germany, Argentina, Chile, Greece, Israel and Italy. With a continued increase in the number of countries favouring the legalization of medical cannabis along with its increasingly positive shift in public opinion, there has also been a shift towards stricter regulatory frameworks and more stringent regulatory controls.
Globally, countries have adopted Good Manufacturing Practices (GMP) as the “gold standard for international quality compliance” for the production of cannabis products [5]. The adoption of these regulatory standards aligns with pharmaceutical industry standards and their production of medicinal products [6]. With this in mind, you’d think medical cannabis is held to the same standard as a medicinal product. It isn’t. As a result, LPs in Canada have begun producing cannabis to the higher GMP standard, specifically EU-GMP certification [7]. As such, a number of Canadian companies have become EU-GMP certified and are actively exporting medical cannabis to the European Union (EU), making the implementation of GMP paramount to a company looking to enter the cannabis space globally, not just the EU.
When considering the limitations GPP compliance presents to the international medicinal cannabis market, it’s easy to see why companies strive to implement GMP at their cultivation or processing facilities, regardless of the cannabis products they’re looking to produce (e.g. dried flower, oils, etc.). Although GPP is recognized in Canada and provides a good foundation from which to build upon, there are a number of differences when comparing GPP and GMP. Looking at the GPP requirements found in Part 5 of the Cannabis Regulations, the most basic fundamental principles of GMP are covered. This includes, but is not limited to, premises, equipment, quality assurance, the requirement for a sanitation program and the implementation of established procedures.
Although GPP implements these principles, a significant number of differences exist. In order to demonstrate how these two standards differ, examples will be provided below. Since cannabis companies are currently exporting medicinal cannabis to the EU, EU-GMP has been selected as the benchmark for this comparison.
When comparing the EU’s GMP requirements [8] to the GPP requirements established in Canada, it’s easy to see gaps that exist between the two quality compliance standards. For example, in EU-GMP, a robust quality management system is required, however, this provision is non-existent when referencing the requirements for GPP [9].
Another example can be seen when comparing the requirements for personnel. In EU-GMP, an organizational chart demonstrating the relationships between the “heads of Production, Quality Control and where applicable Head of Quality Assurance or Quality Unit” along with, “specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities” is required [10]. The above provision does not exist in the GPP requirements.
A third example can be seen in the premises requirements for the and equipment. In EU-GMP, there’s a requirement for the monitoring of environmental conditions in certain areas of the facility whereas, in GPP, this isn’t required [11]. Another example can be found in regards to documentation. In EU-GMP, Good Documentation Practices (GDP) are required to be implemented whereas, in GPP, this requirement also does not exist [12].
In addition to the examples above, EU-GMP requires that the standards set forth in Annex 7 – Manufacture of Herbal Medicinal Products are also implemented and followed [13]. Adherence to this annex essentially requires the segregation of “dirty” activities from “clean” activities. For “dirty” activities, including cultivation, collection and harvesting, Good Agricultural and Collection Practice (GACP) applies. Once these activities have concluded, ancillary “clean” activities related to the processing of the collected material (including extraction, purification, concentration, and final dosage form production) triggers the requirement for not only GACP but also GMP. In GPP, no such requirements need to be followed in a cultivation and/or processing facility. It’s important to consider the segregation of these activities in the design of your facility to ensure that the process flow of material is as linear as possible, moving from “dirty” activities toward “clean” activities, eliminating the need to backtrack throughout the manufacturing process flow.
When considering the information above, it’s clear why there has been such a shift in the regulatory and quality compliance standards companies are now implementing. Although GPP are solid regulatory frameworks within the Canadian recreational and medical markets, they can also be limiting in a broader sense internationally. This, coupled with the increase in cannabis research being conducted around the world, further solidifies that cannabis businesses should be forward-thinking and taking into consideration the bigger international picture and opportunities that will present themselves over time.
Once more research is conducted and data related to the safety and efficacy of cannabis and its phytocannabinoids becomes readily available, it will be harder for countries to ignore the evidence supporting the medicinal benefits that cannabis provides. With this in mind, it is my belief that more Canadian cannabis companies will proactively plan for the future when it comes to quality compliance. By planning accordingly, companies will be able to better position themselves for a smoother transition from GPP to GMP, alleviating some of the challenges associated with the time-consuming and costly process. By doing so, cannabis companies will further allow themselves the opportunity to not only establish themselves in Canada but also as key contributors internationally as well.
References:
[1] How did Canada get here? A timeline of cannabis (and hemp) from prohibition to legalization
[2] Marihuana for Medical Purposes Regulations
[3] Part 5 – Good Production Practices
[5] Going Global? Join the GMP Parade
[6] Good Manufacturing Practices
[7] In race to win Europe, Aurora Cannabis and other Canadian companies pursue EU-GMP
[8] EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines
[10] EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines – Chapter 2 – Personnel
[12] EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines – Chapter 4 – Documentation
[13] Annex 7 – Manufacture of Herbal Medicinal Products