Drugs are not just therapeutic products. They are also commercial brands. Just as Gucci, Rolex and Apple provide immediate name recognition, pharmaceuticals include such superstars as Viagra® and Cipralex®. And while the disclosure of a Rolex as a fake may cause distress, it is not known to be lethal. This is not the case with counterfeit drugs. Millions of people die every year due to erroneous treatment with counterfeit drugs. In order to break the cycle of bleak statistics and enhance patient safety, serialization legislation has already been put in effect in several large markets like China, Turkey and Argentina, and over the next 2-3 years all major markets will require serialization of pharmaceutical products. There is no “wait and see” – by 2017, all life science businesses must comply with EMA legislation. However, there is a good deal more to serialization than mere compliance. This article will point out some of the business benefits that go beyond compliance and are ready to be taken advantage of.
Nobody wants to jeopardise patient safety, and seriali- zation has been generally well received by the industry. Still, it is no secret that the volume of regulations and the frequency with which they appear disturb the busi- ness at some level. Initially, any regulation may seem an impediment. Business processes are subject to change, new software must be implemented, tested and vali- dated, what to speak of the fact that being compliant requires a significant investment. However, since you will be forced to make the investment, why not make the most of it and pick up on the benefits derived from serialization?
Serialization is the concept of recording, tracking and managing data about drugs and other therapies on the individual item level, allowing companies to follow the product all the way from the packaging line and through the supply chain until it is passed over the counter to the patient. Additionally, the companies should then be able to document this often global journey.
‘In theory, this is a simple concept, but, in practice, it involves many processes, integration of a series of complex systems, and many players – and finally it involves a lot of data. Basically, it is this data that holds the potential for added benefits. However, you have to look at data in a new way and make sure the data is available in the right places in the organisation,’ says Torben Vogt, Life Science Industry Expert and General Manager for NNIT in the US.
In the wake of the infrastructure technology and soft- ware implementation serialization requires, there is an opportunity to substantially improve the business case. By integrating the systems processing the continual feed of data and meta data from systems that are his- torically disparate; e.g., in sales and production, the business value of information is maximised. And with data on hand regarding market changes, inventory and marketing campaigns, for example, you are able to plan in greater detail for a longer period, optimise logistics, enhance agility and shorten your reaction time. Finally, automation minimises errors and greatly increases the effectiveness of any recall.
We can help you comply and take advantage of the immanent business advantages Together, NNIT and NNE Pharmaplan offer the full range of services related to a serialization project. Starting with a thorough business analysis, combining the regulatory road map for serialization in your mar- kets with the packaging infrastructure of your compa- ny and your CMOs, we enable you to plan your invest- ment optimally. Once the solution has been designed, we implement it, ensuring full integration with ERP and other production infrastructure all the way to the actual sale.
Our Track & Trace services cover full-service global serialization consultancy, program management, imple- mentation and application outsourcing. In 24 months you can be fully compliant and have an improved supply chain visibility, traceability, control and planning.
Compliance with serialization regulations
Supply chain optimisation
Sales planning and forecast
Brand value and integrity