In this article, Dr Frank Binder, VP of global supply chain management at Santen and keynote speaker at NEXUS '17 in Barcelona, discusses the challenges and opportunities that serialisation presents to mid-sized companies.
Dr Frank Binder, VP of global supply chain management, Santen
Frank Binder
Implementing a fully compliant serialisation solution in time for upcoming US and European regulations in 2017 and 2019 respectively is a complex task for any pharmaceutical company. While larger companies have the budget and expertise to dedicate full time resources to the process, mid-sized companies are faced with a more challenging scenario, with many falling behind in their serialisation preparations.
The serialisation challenge
More than just an exercise in installing packaging line equipment, serialisation is a complex issue that transforms and affects the whole pharmaceutical supply chain from the manufacturing process to logistics and the end sale of the drug product. It is not an easy journey for a mid-sized company to embark upon, particularly with varied requirements across geographies, multiple partners to manage and without the full-time resources to dedicate a team solely to the project.
Aside from internal operational readiness realised through a company-wide serialisation programme, it is also necessary to ensure that the contract manufacturing organisations (CMOs) you are working with are prepared for the forthcoming requirements. Some CMOs are very late to the game, which can prove challenging when managing a complex web of partners at different stages of their serialisation journeys. Being under-prepared is not an option; it would be irresponsible to count on any postponement of upcoming deadlines so it is essential that serialisation projects are prioritised as a matter of urgency.
Journey
Key considerations for mid-sized companies
Plan for success
As a starting point, companies should develop a comprehensive plan that considers the time critical elements of the project and outlines key milestones. This should consider the end-to-end process and take into account current internal processes as well as ensuring that external manufacturers and logistics providers are prepared. The key to success will be the deployment of an experienced and knowledgeable project team that can identify gaps at both a process level and a technical level. Taking a step back and looking at the entire process with internal representatives from manufacturing, supply chain and quality functions, as well as external solution providers, CMOs, contract packaging organisations (CPOs) and third party logistics providers (3PLs), can also be a useful exercise to understand where you stand from an operational perspective.
Focus on internal processes
One of the most important takeaways from our serialisation programme to date is to never underestimate the internal processes that need to be put in place. Accounting for every eventuality will ensure that the business runs smoothly, for example allocating specific roles and responsibilities at different stages of production and distribution will avoid bottlenecks throughout the supply chain. For example, what do you do if part of a shipment gets damaged during transportation? Who will look after this process? Reviewing and refreshing your internal processes can also bring wider business benefits as a more reliable process can help to minimize product damage, recalls or loss.
Understand the global landscape
One of the biggest challenges mid-sized companies servicing global markets will face, is the diverse regulatory requirements across the countries in which they operate. Although there are some commonalities mainly through the use of a GS1 standard 2D matrix, it is important for the serialisation team to connect with local authorities to fully understand the current and future landscape. This can be a time-consuming exercise and without dedicated resources in place to regularly monitor new requirements, companies should consider working with third party solution providers that can often add value and provide global expertise. To facilitate seamless data exchange with your trade partners, it is beneficial to look for a solution provider that can provide the opportunity to join a network to support high volumes of transactional data and interoperability with companies across the world. Networking at serialisation events is also useful, allowing companies to share best practice and gain a better understanding of the global requirements from colleagues in the industry.
Final thought
Far from just a technical exercise, serialisation has the potential to change the entire pharmaceutical supply chain. It will add a whole new level of complexity, there will be new possibilities to fail but also new opportunities to gain wider business benefits. What is clear is that for any company, regardless of size, being serialisation ready is a matter of survival. Leveraging the support and expertise of third party solution providers while developing a comprehensive internal process, in parallel with technical implementation, will certainly help mid-sized companies remain competitive and compliant.
Frank Binder (Santen) will be presenting at NEXUS 17, an annual forum, hosted by TraceLink, dedicated to shaping the future of track and trace in the life sciences industry, on 7 and 8 June in Barcelona.