The growing threat of counterfeit medicines entering the pharmaceutical supply chain has led more than 50 countries to introduce serialization laws that help ensure patient safety.
The effective protection against counterfeiting through product coding requires multiple inter-connected systems across manufacturers and supply partners to synchronise together, including network, enterprise, site-level, line/warehouse and device level systems.
To meet these regulatory requirements, Germany-based contract manufacturing organisation (CMO) R-Pharm Germany GmbH chose to connect to the TraceLink Life Sciences Cloud platform to manage and exchange its serialization data. Here, the company shares its journey to compliance.
R-Pharm produces and packages pharmaceuticals and nutritional supplements for customers that are distributed in more than 150 countries. The company’s product portfolio comprises small, medium and large volume order sizes, with approximately 1,500 stock keeping units (SKU).
The company required a Level 4 and Level 5 partner that would allow it to establish connections with its customers as well as manage and exchange its serialization data to achieve readiness in advance of regulatory deadlines in many countries, including the EU’s Falsified Medicines Directive (FMD).
With substantial product volumes and a consistently high service level to maintain, any cloud platform would need to provide a high degree of flexibility and the ability to manage complexity while streamlining the process of ‘on-boarding’ its new customers.
Choosing a solution for data management
A partnership was formed with TraceLink as the company’s Life Sciences Cloud enabled R-Pharm’s customers to immediately connect with the CMO via a single connection. This removed the time-consuming and costly task of individual point-to-point connections and enabled seamless and scalable data exchange and master product data management via established interfaces. With more than 650 companies subscribed to the platform and 265,000 partners exchanging data, it is the world’s largest track and trace network.
An adaptable and robust IT architecture has been implemented by TraceLink at Level 4 and 5, to meet internal and external demands, i.e. system interfaces, software, reporting, handling and data security. In particular, TraceLink enables R-Pharm to seamlessly manage the integration and onboarding of new customers, eliminating any point-to-point connections through TraceLink’s network architecture.
Achieving regulatory preparedness
Through its partnership with TraceLink, R-Pharm is now part of an established network to exchange data across the supply chain. This enables the company and its customers to be compliant with global track-and-trace requirements at levels 4 and 5.
It is anticipated that its serialization programme will enable R-Pharm to produce and manage 120 million serialised packs and their associated data per year. Partnering with TraceLink has enabled the company to achieve readiness well in advance of mandates coming into effect in many countries, including for the EU’s FMD, helping to increase its advantage over many of its competitors.