Last month, we wrote a blog on some of the key things to consider when deciding whether or not to sell your cannabis product in a new market (take a look here). We touched on trends, regulation, legislation, and consolidation. In this post, we wanted to explore how you can prepare to sell your products overseas - with a particular focus on cGMP (current Good Manufacturing Practices).
If you’re new to GMP and curious why it’s important - check out this article.
Preparing for international expansion - three tips from us
- Consider regulation & geography
Regulations regarding the production of recreational/medicinal cannabis varies based on geography. If you are in Canada and want to sell in Europe, you need to have EU-GMP qualified products as outlined by Eudralex. If you are in the United States and want to create a pharmaceutical that needs to be approved by the FDA, the facility will need to be US-GMP certified.
Understanding a product's endpoint and the regulatory requirements of that specific geography will help prioritize where the landing point of your product should be. Once you have an idea of the geographies that will work for your company, seek local experts to get their insights. Consultants will help uncover details that you might not have thought of. If you need any recommendations on who to contact in a particular area - let us know!
- Get in a GMP mindset
If you’re planning on international expansion - becoming GMP certified is essential. It’s hard to know exactly how much time and effort any one facility will need to become GMP compliant, but it’s certainly no small feat (we know, we’ve been through the process!)
Preparing your team to have a GMP mindset, or cultural alignment towards becoming GMP compliant may sound fairly trivial, but it will be a big help in making the transition sustainable over time. For your GMP implementation to be a success it's vital that you adopt and maintain a solution focused mindset, be ready to overcome challenges as a team and work across departments and up and down the organizational chart. As one saying goes, “plans are useless, but planning is indispensable.”
3. GMP everything - even your cultivation & manufacturing software
As a producer, your whole company needs to be fitted to GMP standards. That means everything, including the structure of your facility, production and sensor systems, QA and QMS systems, quality programming such as auditing protocols, and batch production record and inventory management software. That’s right, even your software requires specifications to meet standards like Annex 11 for EU-GMP certification and Title 21 CFR Part 11 for FDA certification.
If you’re planning on going international, make sure that the software currently in use at your facility is GMP validated. Likewise, if you’re shopping around for new solutions, ensure that GMP is on your list of requirements for a new provider.
If the individual elements of your manufacturing tech stack are not GMP, you will have to pay for them to go through the validation process. This is another large expense on top of an already very hefty investment, so definitely one to avoid.
Again, becoming a GMP validated producer differs from facility to facility, but it will certainly cost resources - financial, human, organizational. Preparing in advance to understand the margins, the costs of labour, the time spent on running a sanitization record can help inform how a producer can move towards achieving economies of scale and if the right software is chosen, can also help you reach GMP certification.
Cannabis production is capital intensive, to say the least, so having early conversations around software, labour, COGS, over time will move the dial towards scaling effectively.
Planning on getting GMP certified and looking for GMP validated software? Get in touch: firstname.lastname@example.org