The global market for medicinal herbs and cannabis, in particular, has grown rapidly. Consequently, the safety and quality of these herbal medicines have become more important for both health authorities and patients. "Unfortunately, due to social and cultural constraints, growing cannabis is still perceived as a grey area activity. Fulfilling the Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (EU-GMP) requirements provide the regulators, companies, and also the patients a framework where the production fulfills the major objective: protecting the patient," explains Luís Meirinhos Soares, GACP and GMP Auditor and Consultant at Cannavigia.
Luís Meirinhos Soares
Luís explains that after years of social, regulatory, and scientific mistrust, the process is not just centered on building a new industry but also on building trust. "One of the major objectives of GACP is making sure that during the cultivation and processing of the plant, the contamination is minimized, either by water, substrate, or even from the handling by staff. By ensuring this, patients will be sure that the product they are taking does not cause any harm. We should recall that cannabis is often taken for chronic illnesses, and patients take it for years, so it's very important that the cultivation is always done in a consistent way to achieve the same product all the time. GACP and GMP provide a framework to make sure this is done consistently and by following the best practices."
Cultivation as the critical step
Luís refers to GACP key areas: control of starting materials and service providers (from seeds, cutting selection, fertilizers to water and pesticides) and standardization of processes and methods. "As it is widely known, GACP is a set of rules to be applied during the cultivation stage, and it's the GMP regulations, in particular GMP annex 7 applicable to herbal medicinal products, which define what sort of activities have to be conducted during the manufacturing process. This means that the Qualified Person under the GMP is ultimately the one responsible for verifying and guaranteeing, by doing audits, for example, that the plant was effectively cultivated according to these practices. The cultivators must follow GACP guidelines, but ultimately it is the responsibility of the GMP manufacturer to show that the cultivation step has been done appropriately."
According to Luís, that is why cultivation is, in this case, the most important step. "In a general sense, the GMP part does not increase the compliance of the plant quality. Therefore, cultivation is the critical step. Furthermore, the cannabis plant is very complex. It's a living being, and it is intrinsically variable. Therefore, one cannot rely on a single certificate of analysis to know the quality of the plant. Instead, the product is a reflection of the production process, as the quality of the plant is ultimately regulated and determined by the cultivation."
Track and trace software to achieve transparency and compliance
For the newly emerging cannabis supply network, it is essential to establish trust and create transparency. "You should have regular audits or regular control over the cultivation process. A way of doing that is by using track and trace software, which will serve two purposes. For the cultivator, it will allow you to show that you are cultivating in a good way. It will also give you a competitive advantage because you can show your buyer that you have cultivated the plant according to the best practices. On the other hand, the GMP entity, which is ultimately buying the flower, will have the possibility to verify in real time if the rules and requirements are effectively fulfilled. Ultimately, using a track and trace software introduces transparency in the process, giving trust to all the parts involved: cultivators, manufacturers, and the patient." Luís also explains that by adding sensors, the software can gather data that allows cultivators to identify problems in the crop and implement the right actions timely and effective. "Each plant can be assigned a bar code or QR code to monitor its improvement over time and also suggest what is needed for the optimal plant grow."
Considering that cannabis is a controlled substance, it means that producers need to account for everything that is produced, Luís explains. "This is a peculiar production activity where both the product you are looking for, the dried flower, as well as the residues have to be accounted for. It's very easy to lose track of all the amounts of waste during the trimming and pruning process. Therefore, using track and trace software where you can record everything will keep you up to date and will show that you are being compliant."
"Understanding the regulations is key to success"
"The biggest challenge I see is that most of the companies cultivating don't come from a pharma background," Luís adds. "The biggest obstacle is that companies struggle and try to fight the regulations. We all live in a regulated society in which we establish rules for ourselves so we know exactly what is being done and why. So it's important that people know the regulation that is applicable to them. Instead of seeing the GACP and GMP as something that is challenging them, they should see it from a positive point of view, trying to understand why certain activities are mandatory. We should not forget the ultimate purpose of GACP, which is to provide patients with a safe, consistent, and reliable source of medicine. All the tasks that have to be done are there to minimize contamination, either by microbial agents or fungi, but also from heavy metals or excessive use of pesticides," Luís explains.
"Therefore, I would advise people to try to understand the regulations, try to understand why you need to do this. The regulations don't mean that cultivators do not know how to cultivate. GACP is much more about showing what you are doing; it provides guidance on how to demonstrate that what you do is reliable," Luís explains. "By implementing the proper SOPs that describe what your cultivation conditions are and taking extensive records of every action you take, you not only show you are compliant but you also show that you are able to do it consistently. Relying on a robust track and trace system can definitely be the key to achieving full transparency throughout the supply chain."
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