SERIALTRAC® : Flexible solution to ensure fmd compliance
NOVA LABORATORIES
Nova Laboratories was established in 1994 in Leicester (UK) by a group of ex-NHS pharmacy staff.
Nova Laboratories provides sterile and non-sterile clinical trials medication to a global customer base of pharmaceutical and biotechnology companies, academic and charitable institutions, as well as the NHS. In particular, Nova Laboratories holds the market authorization for the Xaluprine® 20mg/ml oral suspension, a product that belongs to the group of medicines called Cytotoxics that is used in chemotherapy treatment of acute lymphoblastic leukemia. The 20mg/ml packaging is intended mainly to children.
Xaluprine® gets produced in small size batches. It gets delivered is many countries where regulatory constraints are either already enforced, or coming soon into force (EU, USA, Brazil but also, China, Turkey, UAE, Kenya, etc.). It is usually dispensed to patients by doctors themselves, in hospitals. Because of the high value of each dose, and its dedication to oncology children treatment, the product is subject to a high risk of counterfeiting, and well as smuggling and diversion.
Therefore, Nova Laboratories chose for SerialTrac® powered by Inexto because of some major differentiators that were part of their User requirements specifications:
Beyond compliance, Nova was looking for true added value of serialization, tracking and tracing of the Xaluprine® product down to the dispensing to patients, wherever the country. Their target is the fight against illicit trade as well as anticipating the risk of getting faked products entering the supply chain. It requires the complete tracking and tracing of the Xaluprine® product from manufacturing to dispense. This implies the use of simple, standard, cheap and easy to use handheld devices in every third party warehouses down to local pharmacies, hospitals and doctors on the field.
The Inextend® module is part of the SeriaTrac® and runs on any Android or iOS smartphone. Through a simple Operating procedure, any logistic partner contributes to tracking the product to destination, and doctors on the field are capable to dispense a product in a compliant mode, without preliminary training of practicing, and at a very low cost. Their main need was to find a validated solution that is simple to implement, by one partner, at reasonable cost. With the SerialTrac® concept of “regulation in a box”, Inexto is able to provide and assist Nova is the deployment of a serialization, tracking and tracing solution that works from the manufacturing line in Leicester UK down to the ultimate dispensing point.The solution should be flexible enough to adapt to any specific regulatory constraints.
SerialTrac® has chosen for a 100% use of international and open standards like GS1/SGTIN on the coding side, GS1/EPCIS on the event management side, or popular IT platform like Microsoft, Android or iOS on the software side. This makes SerialTrac® the most adaptable and configurable solution on the market.
SerialTrac® can be configured by the QA and line Operator to any destination market, adapting the Level 1&2 (coding and printing specifications) up to Level 5 compliance (interfacing to the various national hubs, and/or adapting to the transactional compliance rules (like for instance the US/FDA/DSCSA regulation).
Cost effective solution
Because Nova runs low volume manufacturing ,the serialization solution cannot be amortized on a big number of items.
SerialTrac® claims to be the best compromise between cost and efficiency, providing creative financial business cases that fits to any particular market situation.