Mauricio Aput, Technical Director of the Fin del Mundo Laboratory shares how the genesis of the laboratory was and the impact of traceability
Laboratorio del Fin del Mundo is the first laboratory in the province of Tierra del Fuego in Argentina. It was created in 2016 by provincial law unanimously in the provincial legislature, in this way it is a public limited company with majority state participation (SAPEM). Within this company name there is also the local drugstore Farmafuego.
The laboratory has ANMAT (2018) authorization for medicinal specialties, secondary packaging conditioning, and export and import of medicines. It currently has 40 employees.
The beginning of the laboratory was a major challenge. Not only because it is the first laboratory in the province, also because of its location. More than 3,000 kilometers by land from Buenos Aires, which means an intense logistics effort, added to the unfavorable weather conditions. Additionally, because everything that enters and leaves the island must go through customs. Mauricio Aput, Technical Director of the laboratory comments: “When we started, only Córdoba, Tucumán, Mendoza and Buenos Aires were part of the list of authorized customs for the import and export of medicines. It was then that Usuahia was enabled”.
Another challenge they had to overcome was the low availability of professionals who could carry out the various tasks. For that a group of few people who came from other places and occupied key positions was assembled, to later expand it. In that sense, the Engineering University was the basis for this objective. “This meant a milestone for the province in the search to diversify the productive matrix, at the moment dedicated to technology,” said Mauricio.
Activities formally began in the middle of 2017. “Given that one of our products was reached by the traceability regulation issued in 2011, when equipping ourselves we considered the incorporation of a traceability system. For the project, we requested proposals from different suppliers, which were analyzed not only for the economic aspect but also for the added value included in it. Verifarma was the chosen option because it solved everything for us, from the information and provision of the service as well as the necessary inputs that helped to easily implement it in the production phase. Then there were trainings for the collaborators. It was made easy because we had a good accompaniment. It is an easy-to-use, agile system, but it is always necessary at the beginning and the predisposition was always good and they helped us at every moment, also with respect to the particularities of our laboratory given the geographical location we are in. In this sense, sometimes there are internet problems and Verifarma’s technical support and its follow-up were very supportive”.
Regarding the impact of traceability, Mauricio comments: “For society it is a spectacular measure, although it comes before certain issues that are not good, it is undoubtedly very positive both for the patient and for the companies since a lot of information is obtained for the internal processes for example and makes the distribution chain appropriate. At first it could be seen as adding another step, especially in laboratories that must make the change, but it is a very important activity that generates efficiency and safety for patients”.
Like everyone else, the pandemic had its impact on Laboratorio del Fin del Mundo, in this case with great impact on the need to coordinate its logistics system. “The main challenge was logistics. For us, the only way to reach the continent by land is through Chile in the Estrecho de Magallanes. So, the flow also depended on the measures taken by that country. Added to this, the air issues. Most of the logistics are carried out by air and the restriction of flights implied a need to rethink our flights in coordination with the medical flights that were operating. The rest were able to operate normally”, says Mauricio. From their area, since the end of last year, they decided to get involved in the production of diagnostic reagents for in vitro use for which they obtained ANMAT authorization and then add the registry for the detection of IGM and IGG antibodies. Now, the qualification for the antigen detection product in saliva is also in process.
At this moment, the laboratory is with several projects, among them the move of its production plant to its own lands. The conclusion of this project will have consequences in the expansion of its list of collaborators and in the diversification of products. “Currently the ANMAT registry is for antiretroviral drugs for VIH and general drugs that are those that we commercialize in the province such as vitamin D, folic acid, ferrous sulfate, among others. We are a young laboratory, 3 and a half years old. This year our own facilities will mean a new step from which to continue incorporating products and growing”, Mauricio closes.