As the body of research on the health benefits of cannabis increases, more and more European countries are legalizing cannabis for medicinal use, including the UK, France, Spain, Italy and Germany. Possession of cannabis for recreational use is still illegal in Europe, but it is predicted that countries will begin to legalize non-medical adult use by 2025.
As laws across Europe open up to medicinal and recreational cannabis programs, Good Manufacturing Practices (GMP) and Good Agricultural and Collection Practices (GACP) guidelines will impact everything from cultivating to processing to importing and distributing cannabis products. In our recent webinar on understanding GACP and GMP for commercial cannabis, industry experts discussed their implications and how and when to incorporate them into your business.
Adapted in 1989 from The World Health Organization (WHO) GMP, the EU GMP guidelines set out the requirements for manufacturing medicinal substances, including medicinal cannabis. According to the European Medicines Agency (EMA), “Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.”
Developed by the WHO in 2003 as a reaction to substandard herbal medicines entering the market, the GACP guidelines for medicinal plants were introduced. The goal was to improve the quality, safety and efficacy of herbal products for consumers and ensure sustainable plant cultivation and collection practices.
While the GMP and GACP provide guidelines to standardize and control the consistency of cannabis production, there are differences in their approach and application. For the most part, GMP concerns the manufacturing and handling of products while GACP is more specific to cultivation practices. For the consumer, both standards provide safeguards to ensure the same quality and efficacy of product every time, regardless of the production batch.
In order to ensure the same reproducible product, GMP and GACP also require a high level of documentation. One of our webinar panelists, Emily Rigby, who is Director of Research and Compliance at the Australian medicinal cannabis company Cannatrek LTD, noted, “We have close to 200 documents that cover our GACP and GMP processes.” Cannatrek is involved in the entire medicinal cannabis supply chain, “from seed to patient.”
GMP and GACP requirements are driven both by production stage and market. “It's important to consider which markets you want access to and when and where GACP and GMP become relevant for your business,” commented Rigby. “In our experience, we're looking at GACP for cultivation, harvest and primary processing, and then GMP when it comes to manufacture and some of our other processing steps, including packaging and storage.” She also noted that every business case is different, and “it is really important that companies seek professional advice on GMP and GACP because there are a lot of grey areas and the guidelines are open to interpretation.”
For growers, the cannabis cultivation process is already complex. It is essential, therefore, to standardize processes so that there is a consistent product for downstream partners and patients every single time. In order to achieve this, Rigby noted the following requirements:
· Reproducible, quality starting materials
· Standardized production steps
· Strict protocols and procedures
· A sound quality assurance system
· Documentation of all activities, from standard operating procedures (SOPs) to record-keeping and traceability
At the end of the day, what you are building is a quality assurance and risk management system.
European companies entering the market need to ask themselves whether they want to focus purely on growing cannabis or handle everything from cultivation through to manufacture and distribution. Companies that plan solely to cultivate, which primarily falls under GACP, could opt to partner with a 3rd-party processor/manufacturer that is GMP certified. Forming such a partnership might even bring a final product to market faster, by enabling both the grower and the processor to focus on what they do best.
It is important to incorporate GACP and GMP planning early on in all of your documentation and best practices. These frameworks have implications that impact facility design, construction, genetic materials, growing processes, hygiene, equipment choice, operations, documentation, storage, packaging, labelling, personnel and so much more. The market you are going after is also a critical part of the plan, as growing for a domestic market may have different certification requirements versus exporting to another market.
Equipment selection and the standard operating procedures you build around them are critical to the quality and consistency of your product. Whether you are choosing dehumidifiers, lighting or other essential equipment, it is important to look for a sanitary design with non-reactive, non-additive and non-absorptive surfaces. The equipment should operate within established limits and tolerances and be of appropriate size for intended use and cleaning.
While cultivation generally falls under GACP and quality risk management generally refers to GMP, there is a third factor to consider –your own specifications, including:
· Spectrum and intensity of light required
· Uniformity and performance of light over space and time
· Ease of fixture cleaning and IP rating
· Low fixture failure rate
Overall, GMP and GACP are all about producing the same high-quality product each and every time, all year round. Your lighting and controls system can play a huge role in this. Intelligent LED lighting and controls can help you standardize cultivation processes and produce the consistent cannabis your market demands.
Want to know more about GMP and GACP and how they apply to your business? Watch the on-demand webinar.
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