TRACK & TRACE
National drug control system
Since 2019, SPI has maintained a team working in research, consultancy and implementation of projects related to drug traceability.
The implementation of the National Medicines Control System (SNCM), defined by Law 13.410 / 16, aims to mitigate the risks of selling counterfeit drugs or below specified. A broad project of horizontal digital integration, of deep interest to the pharmaceutical sector and a source of learning for multiple chains.
SPI actively participates in the development of research related to SNCM. SPI’s efforts to promote advances in pharmaceutical technology in Brazil were recognized by the Brazilian Academy of Sciences, in the format of the “João Florentino Meira de Vasconcellos de Farmacêutica” award granted to our CTO.
SPI researchers were responsible for the creation of SETRM& in 2014, and remain in the leadership of the organization of this which is the main forum for discussion on SNCM in the country.
HCFMUSP SNCM pilot
The SPI researchers were responsible for the pilot, carried out jointly by LIBBS and HCFMUSP, to validate the design of the current operational dynamics of the SNCM.
Since 2017, SPI’s research team has been collaborating with IMT in the development of equipment to support activities related to SNCM in the Warehouse.
As the end of the year approaches, holders need to have the security of having a robust plan to report to Anvisa. SPI has a multidisciplinary engineering with the necessary capacity to formulate and support the management of a holistic plan for the implementation of SNCM. Our offer covers the issues of deployment planning, process changes, necessary technologies, shop floor equipment, integrated project and resource management.
Vertical and Horizontal Integration
In 2009, we were responsible for the deployment of IBM InfoSphere Traceability Server (ITS) in the IBM lab. In 2013 we set up the first SAP Auto-ID Infrastructure (AII) laboratory in Brazil. In 2015 we became partners with TraceLink. The sum of the solid experience of the SPI team in turnkey projects and in the technologies used in the SNCM enabled the construction of a solid consultancy offer. Among the companies that believed in the SPI consulting team are AbbVie and Halexistar.
SPI was responsible for the implementation of the traceability system to serve Roche and P&G in 2015, during the first phase of Anvisa pilots. In this step, prior to the change in regulation, which occurred in 2016, SPI actively contributed to the discussions on the implementation of drug traceability in the Gs1 Brasil, Sindusfarma and Gs1 Brasil working groups – activities that have now been resumed, with the objective of to share knowledge about the do’s and don’ts of the deployment.
After changing the regulation, SPI dedicated itself to supporting TraceLink in the implantations in the United States in order to deepen the knowledge about operational processes and the technology applied by it, having successfully completed the implantation in dozens of pharmacies and hospitals. In this new phase of pilot projects, SPI was a partner of Eurofarma and SeaVision in partnership with Anvisa. SPI also provides the equipment assembly CKD service to Jekson Vision.