Drugs can save lives and give us relief from illnesses and pain – people rely and trust in them. But high quality of drugs is not a natural given. Recent incidents on product counterfeits have raised the awareness that an effort is needed to make sure that patients actually get what they think to be sold, and also other unexpected events may require companies to recall products – which should happen quickly and entirely.
Challenges: achieving regulatory compliance and patient safety
The question drug manufacturers need to solve is how to secure patient safety. How can drug counterfeits and other unexpected events be avoided proactively, how can product recalls be done quickly and efficiently, and how can drug expiries be detected early enough?
This is a task UCB, a global pharma and biopharma company located in Brussels, has identified as priority to solve at the highest quality level. There are global regulations for track and trace in pharma in place, and the regulatory landscape for pharma serialization has been and will be continuously evolving further. On top of complying with all these existing, upcoming, and changing regulations, UCB wanted to go one step further by leveraging the investment made into compliance and also benefit from a process performance and quality perspective all across the supply chain. Not an easy task, but they did it!
Winning strategy: inclusion of all parties through standardized approach
The key to stay compliant with all global serialization requirements now and in the future, to ensure safe market supply all over the world and to further improve operational quality was standardization. All sites, product lines, and external partners like Contract Manufacturing Organizations (CMOs) or Third Party Logistics Providers (3PLs) should adhere to a standardized way of communication.
The reasons behind this approach can be explained as follows: The communication chain can be easily disrupted as they all work in siloes. They have different quality processes and different systems to capture and organize data. This means, it’s hard to stay updated at any point in time, and errors can occur easily through multiple data entries. The manufacturer of the product is accountable for compliance and to make sure that all data are accurate, complete and timely available. The standardized approach not only enabled UCB to gain complete and valid global visibility and cohesion on each product through the entire supply chain. It also saves IT cost and allows to adopt best practices quickly across the organization to maximize global performance.
Of course local specifics and constraints cannot be ignored to achieve realistic successes, so the IT solution driving the processes needed to allow room for flexibility on top of supporting a standardized concept. UCB running one single instance of SAP as corporate ERP system, the technology the project was based on was chosen quickly. The solution provides a single source of truth on product data from production to sales and distribution for all involved stakeholders including packaging and logistics of all plants globally, for CMOs, 3PLs, Wholesalers, as well as for authorities.