Serialization solutions for the global regulatory landscape
A consistent solution for a whole world of requirements
Pharmaceutical companies need to be sure they are doing all they can to secure their supply chains and assure product authenticity. They are faced with a world where the online trade of fake drugs is all too visible, where more and more fake products are reaching licensed distributors and pharmacies, and where a large proportion of counterfeit medicine seizures are of “commercial size.” The failure of a company to demonstrate that it is doing all it reasonably can to secure and authenticate its products could fatally damage its brand and reputation.
Institutions such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US Food and Drug Administration (FDA) are calling for unique identification on every medication package. Laws to implement such measures are being introduced in many parts of the world, but progress and requirements vary from country to country.
Still, it is not enough to just comply with regulatory requirements – policy and regulations are generally lagging behind the problem. Companies need to take the lead themselves. They cannot risk a situation in which lives are in danger and they have failed to implement measures that other companies, whether inside or outside of the sector, have adopted.
Supply-chain security: The best solution for your needs
The pharmaceutical industry is a global business. Companies operate multiple plants in different countries and on different continents. They serve the health needs of individual patients in an official environment that varies greatly from country to country. Any serialization solution for tracking and tracing pharmaceutical products must be able to integrate all these differing aspects of the pharmaceutical value chain while ensuring a consistent, integrated product ePedigree.
A pharmaceutical tracking and tracing solution has to cover all aspects of the global pharmaceutical environment:
Different manufacturing sites and technologies
Different regulatory regimes in different countries
Different timetables and deadlines across various locations
Different product requirements and characteristics for different markets
Pharmaceutical companies face a balancing act when it comes to investing in the best supply-chain security solutions. Siemens provides the global reach to understand the different requirements of your different sites, regulators, and markets, and our technology portfolio offers you a flexible, modular, and scalable response to your needs.
A proven track record on a global scale: Siemens and the pharmaceutical industry
Siemens has a proven track record in item-level identification technologies and aggregation to protect the authenticity of a drug all the way down the supply chain, from production to patient. Drawing on our considerable experience in serialization and in tracking and tracing technology in the pharmaceutical industry and a range of other sectors, Siemens is at the forefront of supply-chain security. We were chosen as the technology provider to the EFPIA’s Swedish pilot project aimed at verifying the identity of pharmaceuticals at the point of dispensing. We are a natural partner to provide you with the best technology available today to ensure product authenticity at the package level – no matter where you are: Our global organization can support you right on site.