In February, serialization of pharmaceutical products became mandatory across the European Union. Contract Manufacturing Organizations (CMOs) have long been gearing up for this change. At 3M, preparations began three years ago and now three manufacturing sites in European and U.S. locations can serialize products. While this transition did not come without its challenges, I believe the new regulations will help protect not only patients, but the pharmaceutical industry as a whole.
Before the new serialization standards took effect, there was no cohesive, industry-wide process in place to prevent counterfeit products from reaching the European marketplace. Additionally, there was no standard process for recalling tainted products that posed a threat to patient safety. By putting everyone on the same page with uniform rules across the board, counterfeiters will be at a much steeper disadvantage, while patients will benefit from tighter quality control.
Pharmacists to Join the Front Line
To put this process into practice, the first step is for manufacturers to place tracking information on the packaging via 2D data matrix (barcode). A pharmacist will then be able to scan the barcode on the package and identify when and where the product was made. Timelines for implementing this function are country specific. In the U.S., the Drug Supply Chain Security Act (DSCSA) took effect on November 27, 2018. In the EU, the Falsified Medicines Directive (FMD) took effect on February 9, 2019. Pharmacist scanning capabilities will follow in the future.
To get to this point, pharmaceutical companies and CMOs have had to do much more than install code serialization equipment on their packing lines. With multiple partners often involved in the development of a single product, complex communications systems must be developed and maintained. Partners, who typically exist as individual entities, must integrate their communications processes, to ensure that the correct codes are applied to the finished product and these individual identification numbers are then transmitted to the purchasing party and to a centralized database which prescribers can access. With so many stages along the way, effective communication is critical to ensure that when a product reaches the marketplace, we can tell exactly where it’s come from.
New Priorities for Pharma Companies
In the pharmaceutical industry, strong relationships with experienced and trustworthy partners have always been important. Serialization takes that need to a new level by assisting the industry in complying with the regulations. As rules become more complex, a partner’s strong track record of success, as well as pharmaceutical and supply chain experience, should become even larger priorities for any pharmaceutical company.
One month after these new rules took effect, we are carefully watching how things progress. We expect to uncover even more opportunities to improve communication and collaboration with our partners as we continue to protect the integrity of the supply chain.