In highly regulated industries like cannabis and pharmaceuticals, maintaining quality standards isn’t just a best practice it’s a legal requirement. Businesses in these sectors often encounter terms like GPP (Good Production Practices) and EU-GMP (European Union Good Manufacturing Practices). While both aim to ensure safe and consistent production, their scope and requirements vary significantly.
Understanding the difference between EU-GMP and GPP is more than a technical comparison it helps define your market access, compliance risk, and long-term growth potential. Whether you’re producing cannabis oils for domestic sales or pharmaceutical-grade products for European markets, selecting the appropriate standard is crucial.
Good Production Practices, or GPP, is a regulatory framework primarily used in Canada. It sets out the minimum requirements for cannabis producers to ensure their products are manufactured in a clean, controlled, and traceable manner.
GPP is commonly required for:
GPP is enforced by Health Canada and forms the baseline compliance for businesses operating strictly within the country.
EU-GMP goes several steps further than GPP. It is the standard used across the European Union for the manufacturing of pharmaceutical products. For any cannabis or pharmaceutical product entering the EU market, compliance with EU-GMP is mandatory.
EU-GMP is required for:
This level of compliance often requires substantial investment in infrastructure, systems, and staff.
Let’s break down the major differences between the two standards:
Aspect | GPP (Canada) | EU-GMP (Europe) |
Jurisdiction | Canada | European Union |
Regulatory Body | Health Canada | European Medicines Agency (EMA) |
Focus | Domestic production | International pharmaceutical compliance |
Inspection | Health Canada audit | EU-authorized third-party inspections |
Process Validation | Basic SOPs | Comprehensive process validation required |
Market Access | Limited to Canadian market | Global (including EU) |
Documentation | Limited to essential records | Full batch traceability and QC records |
Choosing between GPP and EU-GMP depends on your business model, budget, and long-term goals.
If your goal is to distribute within Canada only, GPP compliance will suffice. But if you plan to export cannabis oils or pharmaceutical products to the European market, EU-GMP is non-negotiable.
Startups and small producers often begin with GPP due to its lower upfront costs. However, as businesses grow, they may need to upgrade their operations to meet EU-GMP standards.
It’s worth considering where you want your business to be in three to five years. Planning for EU-GMP from the outset can save time and retrofitting costs later.
While EU-GMP comes with higher costs and more stringent requirements, it brings several business advantages:
These benefits make EU-GMP an attractive goal for businesses with international ambitions.
Not every company needs to reach EU-GMP levels immediately. GPP may be the better choice if:
Many businesses use GPP compliance as a stepping stone toward full EU-GMP certification down the line.
At MF License & Regulatory Consultants (MFLRC), we understand that compliance isn’t a one-size-fits-all process. Whether your business is applying for its first Health Canada license or preparing for an EU-GMP inspection, we provide tailored guidance every step of the way.
Our services include:
By working closely with your operational and quality teams, we ensure compliance becomes part of your business DNA.
Both GPP and EU-GMP offer structured approaches to manufacturing cannabis and pharmaceutical products, but their reach and rigor differ considerably. GPP is a solid foundation for Canadian operations, while EU-GMP is essential for businesses aiming for international growth, especially in the European Union.
Choosing the right compliance standard depends on your product goals, market plans, and available resources. For companies ready to move from domestic sales to global distribution, EU-GMP isn’t just a certification it’s a gateway to new opportunities.
| Disclaimer |
| The above blog post is provided for informational purposes only and has not been tailored to your specific circumstances. This blog post does not constitute legal advice or other professional advice and may not be relied upon as such. |
MFLRC is a one-stop shop for all of your Licensing, quality assurance and compliance needs. Our team has years of experience in the cannabis industry and are experts in all facets. We offer a variety of services that will save you time and money. Let us take the burden off your shoulders so you can focus on what’s important – growing your business.
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Mussarat Fatima, President, and owner of MF Cannabis License and Regulatory Consultants has more than twenty years of experience in Quality Assurance, Quality Control, and Regulatory Affairs within the pharmaceutical, Food and Cannabis industries. She has a Master’s Degree in Food Sciences and Biochemistry; in addition to this, she also has a diploma in pharmaceutical Quality Assurance, Regulatory Affairs, and Quality Control. Also, she has completed several certifications specifically in Cannabis Quality Assurance, Regulatory Affairs, and Facility management from recognized institutes in Canada.
Written By: Mussarat Fatima
President at MF License & Regulatory Consultants
Website: https://mflrc.com/
Contact: info@mflrc.com
