Serialisation introduces tremendous challenges – and equally tremendous opportunity.
Every pharmaceutical company – regardless of size, location, speciality and other differentiating factors – shares one common goal: ensuring that their medications are delivered safely to the patients who need them. The recent rise in counterfeiting, diversion and other illicit activity has put that mission at risk.
In response to growing drug integrity concerns, over 40 countries have introduced track and trace laws to help regulate product as it passes through the supply chain. In 2019, more than 75% of the world’s prescription medicines will be protected by legislation. While no two countries have passed the exact same requirements, they all rely on the use of serial numbers, or serialisation, as the core tracking component.
Serialisation introduces tremendous complexity to your business. Each unit you produce must now be identified with unique data, which in turn must be stored and accounted for over many years. Complying with all the new requirements means solving new challenges, including managing enormous volumes of data, integrating with CMOs, establishing connectivity with customers and trade partners for data exchange, managing serialisation in the warehouse, validation of systems when changes occur, and more. How your business prepares and manages these demands will be affected by many factors, including:
- How many markets, and which ones, you sell product into
- The unique requirements and timelines of each of those markets
- Your product volumes
- What additional roles, such as CMO, your company plays
- The size and diversity of your supply chain
- Where you manage packaging and distribution
- What internal systems you need to integrate
- How many dedicated staff resources you have available
Serialisation also introduces tremendous business opportunity for both your company and the industry at large. With each product uniquely identified, the ability to use serial number information for product verifications, recall notifications, product disposition data, and overall supply chain visibility is within reach. Serialisation – combined with a technology infrastructure that streamlines connectivity between supply chain partners – enables real-time information-sharing that will ultimately lead to better patient outcomes.