Have you ever gone into a ‘big box’ store, trying to find a particular item? Attempting to locate anything in those stores amidst so many products and aisles can feel like you’re working to find a needle in a haystack. However, with current technology, it’s possible to type in the product on your smartphone and find exactly where your product is located and how many are in stock. You can imagine how this scene plays out during the holidays when everyone wants that last trendy toy?! ‘The app is telling me you have one more in the store somewhere…!?’
That process, albeit on a much smaller scale, is similar to serialization in the pharmaceutical industry. To ensure that the products patients receive are authentic, and to eliminate counterfeit goods, regulatory bodies implemented serialization regulations across the industry. These rules require contract manufacturers, like 3M, and packagers for pharmaceutical companies to be able to track and trace each container, carton, and pallet through bar codes and serial numbers.
The need for serialization, however, goes beyond being able to track products. One of the biggest concerns in the pharmaceutical industry is the hazard of counterfeit prescription drugs. These fake products have the ability to fatally harm patients through contamination, or wrong active ingredients or doses in the products.
While serialization has been around for decades, the U.S. government finally enacted a mandate for all pharma companies to follow, with the Drug Supply Chain Security Act (DSCSA). Being a leader in the industry, 3M and Drug Delivery Systems Division (DDSD) already had a serialization mandate in place. Starting in 2012, we have been working tirelessly on meeting the deadlines of all of the global regulations by developing a full global project team at each 3M manufacturing site that oversees every product that we manufacture.
As with any project, the implementation process has endured a few challenges. Because serialization touches so many lines and products, the team has needed a lot of support to meet regulations and satisfy customers.
Fortunately, we have a great team to accomplish what we’ve done thus far. The support we’ve received from all sectors of DDSD and 3M has been overwhelming. It’s what makes this company so great. With the hard work, dedication and support from everyone on our team and throughout the company, we have made huge steps to make 3M a global leader in serialization.