The Good Manufacturing Practices (GMP) are a set of laws/regulations adopted by governments in most countries. These laws are designed to protect patients from sub-standard medicinal products. Medicinal cannabis containing THC is considered a medicinal product. All medicinal products must be produced under GMP conditions.
Before you can be GMP certified you will receive an inspection against the GMP requirements by your national healthcare inspectorate or a qualified auditor of your importer.
We've hosted hundreds of GMP inspections. What we can do for you? Prepare your organization to the best of our ability.
We have a set of plans, documents and standards to get you to EU GMP certification quickly. Is it easy? No. Will it be a lot of work? Yes. But we've done it before, many times. We guide your organization from A-to-Z, from green field to your first commercial sale. We can do as little or as much as you need, we offer fully flexible packages.
EU GMP certification is the perfect opportunity to show your customers your dedication to quality.Let's face it, there are hundreds of producers of medicinal cannabis with poor quality and low prices.
GMP allows you to control your quality, stability and market value. Become a master of your process and quality. The investment in GMP allows you to expand your business dramatically with higher prices.
Medicinal cannabis companies in any stage of their lifecycle, this includes companies that are being set-up. We help -and have helped- companies on every continent.
If you fit any of the listed categories, we can help you become EU GMP certified.
We can also do turn- medicinal cannabis facilities, please contact us for more information.
For starters, get in touch. We can plan a Zoom/MS Teams meeting so you can introduce yourself and your project. During the call we explain the first steps in your EU GMP journey. Or, if you are the curious type, download our phase 1 presentation below and have a sneak peek at what we can do for you.
PCS managed the first medicinal cannabis EU GMP implementation worldwide for in 2016. Since then we've been working on 30+ medicinal cannabis projects in North and South Europe, Africa, North-America, South-America and Australia.
If I have an EU GMP quality system, can I apply for a GMP license?
No. A GMP quality system is a starting point but only 10% of the total GMP process. GMP touches everything; personnel, your building, the HVAC system, the clothing of personnel, the lab, your culture, your clients, suppliers and service provides. Everything that touches the product or affects patient safety is GMP too. It's an enormous amount of work which cannot be covered by a few SOP's.
Can I have the cultivation area under GACP and the processing area under EU GMP?
This is a highly complex question. Get in touch with PCS to discuss your situation in detail. Our rule of thumb; money saved now by keeping GMP and GACP separate is negligible in comparison to the cost of hiring additional staff, having two separate quality systems and rework following future regulatory requirements for full GMP integration.
When should I take the EU GMP into consideration?
From the very beginning. Are you making decisions on which equipment to buy? That's a GMP decision. Are you selecting a builder? That's a GMP decision. Are you hiring a grower? That's a GMP decision. Everything you record under a GMP quality system early on doesn't have to be redone later. Under EU GMP; If it's not recorded it didn't happen.
Can I do outdoor cultivation (in an open field) and process it elsewhere under EU GMP standards?
No. We know that some companies do it but this is not future proof. EU inspectorates start to get a better understanding of medicinal cannabis and the inherent risks of outdoor cultivation to patient safety. Not all impurities can be removed upstream and thus pose a risk to patients. Some impurities closely resemble the active substance and are extremely difficult to isolate.
I have a GMP certificate by a non-EU country, can I export to the EU?
No. You will need an EU GMP certificate issued by a competent authority OR a QP declaration from your importer in the EU.
Will I be inspected by EU GMP inspectors if I'm outside the EU?
In 99% of the cases, no. Germany is (at the time of writing) the only EU country that always inspects medicinal cannabis manufacturers outside the EU. Usually, EU GMP inspections are done "by proxy" through the Qualified Person of the importer in the EU.
How much does GMP certification cost?
This depends on your operation's size. But the general rule of thumb is as follows:
We are happy to visit your organization for an introductory meeting. During this meeting, one of our GMP experts will visit you on location or digitally.
During the introductory meeting we discuss your current status and what may be required to prepare you for the regulatory inspection/client audit. Subsequently we will draw up a project plan for your review.