Leandro is our quality control manager. An agronomist by profession and curious by nature, he approached YVY because of his interest in cannabis. His view for detail led him to be the one who puts the focus on the cultivation and post-harvest processes.
Although Leandro is technically in charge of post-harvest processes, he is also responsible for the certification of the production and this requires him to be present during the entire process, developing the corresponding documentation. For example, if a specific chemical product is proposed for use on the production, Leandro will decide whether this is possible or not, according to the quality standards that we manage at YVY and the demands of the country of destination. Below, he tells us a little about his job.
How is quality defined? What characteristics are taken into account?
My job is to ensure both the quality and the safety of the product.
There are several characteristics that directly define the quality of the flower and their relative importance is given by the particular demands of the client and the demands of the pharmaceutical industry, as is our case. Some of them are: cannabinoid content, finish, size, color, aroma, moisture content, etc. However, there are other factors that determine the quality of the final product, such as crop management, post-harvest processes, supplier qualification, documentation and traceability system, among many others.
Also, safety guarantees that it is not harmful for consumption, for which strict hygiene and conduct standards are followed by the personnel who handle the crops and exhaustive analyses of the products are carried out in accredited laboratories.
What is the difference between growing medicinal, industrial and recreational cannabis?
Both medicinal and recreational refer more to the purpose of consumption than to the cultivation method. In Uruguay, recreational consumption occurs within the framework of licenses for self-cultivation, membership clubs or production within the scope of the State, without the possibility of marketing abroad.
Licenses for industrial and medicinal production are granted by different State agencies (MGAP and IRCCA, respectively). Companies apply for medicinal licenses in order to market the product in the pharmaceutical industry. The main difference with industrial cannabis producers lies in the standards, demands and/or requirements that must be met when producing and intending to market the production. Exporting to EU countries is not the same as exporting to Australia or Israel.
We never grow for recreational purposes. Yes, we do produce industrial hemp and medicinal cannabis for export.
What are the international GACP and GMP Certifications?
The standard that we certify at YVY is GACP (Good Agricultural and Collection Practices) under the guidelines of the WHO and EMEA. These are the technical rules necessary for the cultivation, harvesting and first processing of medicinal plants that can eventually be integrated into health products and are required of those who produce the raw material. The objective is to guarantee that the products are high quality and innocuous, respecting the application of standardized procedures, the registration of activities and compliance with local legislation on agricultural production and labor. In other words, it is important to GACP that medicinal plants and herbal substances are produced hygienically to keep the microbial load to a minimum and that plants are not adversely affected during these early stages.
Similarly, certification in Good Manufacturing Practices seeks to ensure product quality, safety and efficacy, but is aimed at companies that manufacture medicines from flowers. These rules often apply to post-harvest processes, such as drying; for example, if we want to export to the EU or Australia, we need GMP certification as from the post-harvest process.
How does the drying process work and what is the role of the MSP?
We outsource post-harvest services, including drying. This process requires precise temperature and humidity conditions and is a key part of the post-harvest process to obtain a quality product.
There are few companies that dry according to the standards required by the industry. Drying companies must be authorized by MSP to carry out the activity and it must have been granted a GMP certificate to be eligible for YVY.
Standard Operating Procedures are a set of written instructions that describe the process that must be followed to correctly carry out routine activities, such as how to disinfect materials, what tools should be used or hygiene and conduct rules within the premises.This rules define the standards necessary for everything to work in the best way. They must be followed in exactly the same way each time to ensure that the organization remains consistent and complies with industry regulations and business standards. They are reviewed every year and, based on that, the staff is trained on what to do and how to do it.
The great challenge... keeping microbiological levels low to meet international standards, how is it achieved? What do you recommend?
Although this depends on the country of destination, as to the standards they manage it can be said that, in the context of a medicinal product, the degree of microbiological contamination admitted is minimal. It is very difficult to reach these levels when growing outdoors or in low-tech greenhouses, but there are tools and technology that can reduce the microbial load. At YVY we produce in high-tech greenhouses that allow to reduce microbiological levels by the use of physical barriers and hygiene protocols. In order to have strict control, the most reasonable thing would be to work indoors, in premises that are isolated from the weather and with air treatment... This is the great debate in our industry. Indoors or outdoors, that is the question.