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Top five lessons of the EU-GMP certification process

Even before we laid the foundation for our GlassHouse Botanics facility in Whitewater Region, Ontario, our objective was to produce European Union – Good Manufacturing Practices (EU-GMP)-certified medicinal cannabis. Nearly five years after our initial Health Canada licensure, we were thrilled to achieve GMP certification, effective January 2024. 

What we learned along the way:

1. You can produce superior quality cannabis with consistent THC and excellent microbial levels without irradiation, even in a greenhouse:
At GlassHouse Botanics, we achieve consistent cannabinoid values by using consistent inputs; following established irrigation/fertigation and plant maintenance schedules, and controlling light exposure, ventilation, and CO2 application levels. While painstaking, by adhering to GMP during cultivation, we can ensure a consistent THC.

Irradiation is not necessary to achieve good microbial levels. Our flower is mechanically trimmed and manually manicured. Even when each bud is handled, we consistently meet microbial specifications – we employ strict sanitary controls throughout our production process to reduce risk of contamination. 

2. You cannot “partially” operate under GMP:
Adherence to GMP means consistent, comprehensive application of its principles. Think of GMP as a symbiotic microorganism that spreads throughout all processes – it seeps from post-harvest steps into cultivation practices. One day, you discover that every facet of your operation aligns with its standards.

3. You can adjust processes for better yields & higher THC while maintaining GMP certification:
To remain profitable and meet market demands in the fast-paced, ever-evolving cannabis industry, you must introduce new cultivars, improve production practices, and stay efficient. GMP principles are compatible with value-added changes, if you manage them and validate them. Adhering to GMP may slow down the pace of your change implementation, but it will force you to assess changes before acting on them, resulting in a controlled process with little room for failure.

4. Not all GMP-certified companies apply GMP principles across operations AND not all products exported into EU-GMP-regulated markets meet GMP requirements:
Unfortunately, a number of cannabis producers – even some GMP-certified companies – have found regulatory loopholes and ways to exploit them. Some loopholes can be attributed to the newness of the cannabis industry and relative inexperience of inspectors in applying GMP to cannabis. Still, others are related to export partners, and varying laws and leniency in countries of export. 

At GlassHouse Botanics, our objective has never been to get our product out the door at all costs. We are committed to doing business the right way, and that means earnestly following GMP to produce high-quality cannabis that meets or exceeds specifications every time. 

True compliance means never having to worry about 1) being caught shirking rules; 2) loopholes being closed once inspectors catch on; or 3) your product clearing customs.

For us, finding a business partner with equivalent integrity and high standards to support us through the certification process in Germany was essential.

5. GMP is not for everyone:
Earning certification involved meticulous refinement of our processes over the course of several years. It required the creation of state-of-the-art facilities with pharmaceutical-grade processing rooms; continually purified airflow through HEPA filters; and constantly sanitized walls, floors, ceilings, and equipment. It meant developing stricter SOPs and equipping our capable team to implement them.

Not all companies have the capital needed for the initial and ongoing investment. There are higher laboratory fees, and the cost of hiring and training additional staff to run a more complex quality management system (QMS). There are costs associated with stability studies, calibration activities, qualification of equipment and HVAC, for example.

Ultimately, earning GMP certification was worth the cost. It opens a broader market and provides assurance of consistently safe product. 

Mariana Black  is the QAP and chief compliance officer at Glasshouse Botanics – a privately owned producer with an EU-GMP certified facility in Whitewater Region, Ont. that has been exporting cannabis for nearly two years.