Bluestabil receives authorization to store medical cannabis

License for the storage of medicinal cannabis supports a young and rapidly growing market.

Bluestabil, an ISQ Group company, has just received authorization from the regulatory authority, Infarmed, for the storage of medical cannabis in its stability chambers, becoming a partner with unique skills in the country for a young and rapidly growing market.

In order to respond to the emerging market for cannabis and its derivatives for medicinal purposes, Bluestabil started the licensing process applicable to Infarmed so that it could provide its services and support companies in this sector.

According to Margarida Pinto, company manager, “in this way, we help the market to boost the research and development of new products, transferring the storage of products for stability studies to a specialized partner, with the necessary skills, which is our case. ”.

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 specified limits, the same properties it had at the time of its manufacture and throughout the period of storage and use (i.e. its useful life).

The specific requirements for stability testing of herbal medicines such as Cannabis, a narcotic substance, are demanding.

For example, storage needs to be done in climatic chambers that simulate the conditions of the geographic areas where the products are marketed/consumed. In addition, there are specific rules that must be followed regarding quality control, transport, sample and waste handling.

For all this, the installed capacity and optimized processes available at Bluestabil, “make us a partner with unique skills, and unique in Portugal for a young and rapidly growing market, as is the case of medical cannabis”, adds Margarida Pinto.

competence and security

With several years of experience, Bluestabil develops its activity in a GMP area, superior to 300 m2 and currently has more than 100,000 samples stored and different climatic conditions according to ICH guidelines.

The company has the competence and capacity to deal simultaneously with different product storage projects for pharmaceutical stability studies, which include products and substances derived from the cannabis plant for medicinal purposes.

All climate chambers for sample storage are controlled using monitoring and alert systems, 24 hours a day, 7 days a week (in compliance with 21 CFR part 11).

“For the safety of the samples we receive, we have implemented contingency plans for climatic chambers and have installed several access control and monitoring systems, in addition to other security measures, which allow safe installations and in compliance with the applicable legislation”, reinforces Margarida Chick.