The legal medical cannabis industry is in full bloom across the globe. In North American markets, the dominant cannabis firms have firmly rooted their positions and are now setting their sights to Europe for new growth opportunities.
While medical cannabis is legal in a number of European countries already, it’s estimated that the EU's medical cannabis market could expand to over 123 billion euros within a decade.1
Gaining access to the EU’s medical cannabis market is no easy task – almost all medical cannabis that gets exported to Europe must come from a Good Manufacturing Practice accredited facility. Good Manufacturing Practice (GMP) is a best-in-class set of regulations that covers all facets of pharmaceutical drug production from raw materials, equipment, facilities, down to training and personal hygiene of staff.
GMP standards ensure pharmaceutical products are fit for purpose, high quality, consistently made, and safe for consumption. GMP regulations dictate that equipment must be made in a way that is streamlined, safe, and reliable.
GMP regulations are enforceable by law and once GMP accreditation is obtained, it must be maintained. Failure to do so can result in the loss of market access, fines, or class action lawsuits.
Gaining GMP accreditation has a double effect of providing access to new cannabis markets and improving your brand reputation. When consumers see a GMP-labelled cannabis package, they know the product is safe, clean, and will work as advertised. GMP certification also fosters trust with supply chain partners, which saves time and money when the time comes to make deals.
As an international GMP-compliant equipment supplier to the pharmaceutical and recreational cannabis industries, Vitalis specialists have a deep understanding of not only Canada's Good Production Practices (GPP) but GMP regulations around the world and will ensure that the qualification of the Vitalis equipment goes smoothly.
Since GMP rules are flexible and not a specific set of instructions, it’s the responsibility of every cannabis exporter to bring their production facilities into compliance with GMP rules. Due to the massive scope and highly technical nature of GMP, it’s vital to get the help of an experienced consultant early in the compliance process.
Bringing in a GMP Consultant:
A GMP consultant looks at your facility, equipment, processes, documentation, and even your supply chain to determine what is required to bring your facility into compliance, and how to focus your company resources on the highest impact areas.
Through the Validation process, you’ll create in-depth documentation proving that you’re in compliance with GMP rules every step of the way, so that your facility passes inspection the first time. While qualifying equipment is ultimately the customer’s responsibility, a GMP consultant will help you through the process.
What Documentation is needed for GMP Qualification of equipment?
A typical equipment qualification process will begin with the User Requirements Specification (URS), which outlines a customer’s regulatory, materials, construction, and safety needs. At Vitalis, we aim to reduce the validation burden on the customer by providing standardized URS documents that reflect our standard machine offerings as a starting point. Customers then review this document and work with Vitalis to tailor the requirements of the equipment to suit their processes.
Following the URS is the Design Qualification (DQ), which translates the requirements in the URS into the equipment design. For efficient auditing purposes, it’s critical to have traceability between the URS and the DQ. The results of the Design Qualification allow a customer to assess the suitability of the equipment for their facility.
Upon completion of the build and before shipping to the customer, a Factory Acceptance Test (FAT) is performed. During Factory Acceptance Testing, the equipment is tested under the minimum and maximum operating conditions to ensure that it performs as expected. Measuring devices such as gauges and sensors are tested for accuracy, and safety features such as e-stops are checked to ensure they are operating as designed. The FAT is reviewed by the Vitalis Quality Team and supplied to the customer as part of the turnover package.
Before a piece of equipment can be used in production, it undergoes an Installation Qualification and Operational Qualification (IQ / OQ).
Installation Qualification is a process that includes checks to ensure equipment has been correctly installed. As well, it verifies that utility connections have been made properly, that the equipment has been placed in an acceptable location, and that it adheres to the manufacturer's design and install requirements.
Operational Qualification is the process of running the equipment at its maximum and minimum operating parameters to ensure the equipment performs safely and consistently at all operating ranges and provides verification that the system is ready for product runs.
Vitalis not only provides an IQ/OQ protocol as standard with every GMP machine, but our expert Service Technicians will also visit our customers to execute the IQ/OQ protocol.
The last qualification step is the Performance Qualification (PQ). The PQ is the documented verification that systems and equipment perform effectively under prescribed production conditions. That is, it qualifies the customer’s approved process methods and product specifications. While the customer is ultimately responsible for this qualification step, Vitalis can offer support when needed.
The Turnover Package (TOP) is the final set of documents in the qualification effort that provides the documented evidence that the equipment was designed, constructed, and tested in accordance with the customer's requirements. The Turnover Package includes material traceability records, certificates of compliance, engineering drawings, critical user information needed to maintain the system like maintenance intervals and procedures, and spare parts lists. It is also critically important that the documentation provided in the Turnover Package adheres to Good Documentation Practice, which outlines how documentation should be prepared, filled out and corrected.
Vitalis assembles a comprehensive Turnover Package for every GMP system built. As experts on the design and construction of the machines, it makes sense to ensure that all documentation is accurate and ready for delivery. Taking this step helps to reassure customers that their Vitalis equipment can be qualified for compliance within their GMP environment. It's just another way that Vitalis continues to lead the industry in GMP and customer support.
1. Will Europe be the world’s largest cannabis market? https://www.healtheuropa.eu/medical-cannabis-market/90033/