The specific requirements for stability testing of herbal medicines such as cannabis, a narcotic substance, are demanding.
In order to respond to the emerging market of cannabis and its derivatives for medicinal purposes, Bluestabil, an ISQ Group company, has recently started the licensing process with Infarmed to offer its services and support companies in this sector. And there is good news.
Bluestabil has just received authorization from the regulatory authority to store medical cannabis in its stability chambers, becoming a partner with unique skills in the country for a young and growing market.
The stability of pharmaceutical products and substances derived from the cannabis plant for medicinal purposes is defined as the extent to which a product retains, within certain limits, the same properties it possessed at the time of manufacture and throughout the period of storage and use (i.e. its shelf life).
The specific requirements for stability testing of herbal medicinal products such as cannabis, a narcotic, are demanding. For example, storage must take place in climate chambers that simulate the conditions of the geographical areas where the products are marketing/consumed. In addition, there are specific rules that must be followed regarding quality control, transportation, sample and waste handling.
With several years of experience, Bluestabil operates in a GMP area of over 300 m2 and currently has over 100,000 samples stored in different climatic conditions according to ICH guidelines. The company has the expertise and capacity to simultaneously handle multiple storage projects for pharmaceutical stability studies, including products and substances derived from the cannabis plant for medicinal purposes.
All climatic chambers for sample storage are controlled by monitoring and alarm systems, 24 hours a day, 7 days a week (in compliance with 21 CFR Part 11).
The Cannabis Market in Portugal
The expansion of the business fabric of the cannabis industry in Portugal and its growing attractiveness has encouraged the emergence of several companies. With the legalization of medical cannabis, research and development activities in this field are intensifying. The main players in the industry are investing in strengthening their R&D capabilities through the creation of research hubs and centers. Several of the projects launched are even supported by EU funding. As a result of this dynamism, employment, production and exports of medical cannabis in the country are growing very fast. Since Portugal is a small market, most of our production is exported, mainly to Germany, Israel and Spain.
