Category: GMP Cannabis Facilities
EU-GMP Compliance for Cannabis Extraction and Manufacturing Companies
PBE Expert Inc.
Good Manufacturing Practices is abbreviated as “GMP” and is a product quality standard that many medical cannabis extraction and manufacturing businesses seek, usually in order to export their cannabis products to other countries. The biggest importers for cannabis products are countries in Europe, and since the certification is required by the jurisdiction of the importer, the European GMP standard (EU-GMP) is the most frequently sought certification.
Cannabis growers, because they are handling unprocessed plant material, would not seek GMP certification; they would seek a Good Agricultural and Collection Practices (GACP) certification and would likely sell their plant material to a GMP-certified extraction company. Some cannabis production businesses have GACP certification for their cultivation department and GMP certification for their extraction and manufacturing departments. The two certification types are very different because GACP standards come from the food crop farming industries and GMP standards come from the pharmaceutical industry.
The process of getting GMP certified starts with the company who will be receiving your shipments in the destination country. But before you focus on certification, you need to plan out your facility, business operations and documentation system, all of which need to be built with certification requirements in mind.
If you are considering starting a cannabis business that will need GACP or GMP certification, the first thing to do is to talk to experienced consultants and companies who have experience setting up these kinds of process, mechanical and compliance systems. This involves engineering services for clean rooms, facility design, HVAC & dehumidification, disinfection control, mechanical, electrical & sanitary design engineering (ASME-BPE), project management, consulting, training, processes, cleaning, disinfection validation, commissioning of systems, standard operating procedures, and about 25 categories of compliance documentation.
Cultivation Sector Consulting has partnered with PBE Expert Inc. of Quebec, Canada in supporting the creation of GACP and GMP compliant cannabis production facilities around the world.
GMP compliance starts with a conceptual design for the building. Greenhouses for cannabis cultivation are unlikely to qualify their processing areas for GMP compliance because greenhouses are too permeable to outside contaminants. Indoor facilities are much easier to keep clean and controlled. But if you are planning an indoor facility, it must have the right type of layout, room orientation, cleanable surfaces, cleanable panels, discrete climate control and air purification systems, plumbing design, building security, GMP processing equipment types and specified architectural finishes that are eligible for GMP certification, just to name a few considerations.
GMP certification planning is no small task! And it’s not cheap either. Think of it as being like starting up a pharmaceutical company in terms of cost and complexity. It’s common for a budget of at least $300,000 to be spent on the engineering, documentation, training and implementation of a GMP compliance system for cannabis, but the actual cost depends on your project size. Prepare to spend 4-6% of your project’s budget on GMP compliance. So if your project is a $20 million project, your GMP costs will be between $800,000 and $1,200,000.
Interested in GACP compliance for Indoor Cultivation? Read more about GACP Cannabis Compliance Here.
