If you live in the US, it’s seriali“z”ation. Regardless of how you spell it, track-and-trace is coming. The Drug Supply Chain Security Act train, while delayed a bit, is still thundering down the track (pun intended). You know who hates serialisation? Smaller CMOs. Implementing serialization is expensive and without a massive number of customers over which to spread the cost, some smaller CMOs could be in a world of hurt. According to Tracelink, as many as 400 CMOs will not be ready for upcoming US and EU track-and-trace regulations. And if you can’t afford to be compliant, then perhaps the next step is to consolidate. Looks like this trend is far from over. So, buckle-up sippy cup, get your CMO strategy in line, and enjoy the roller coaster ride.
The clock is ticking on global serialization compliance. (But if you’re behind, don’t feel bad. We thought this article was going to be about breakfast foods.) As the deadline approaches, anyone selling pharmaceutical products into the U.S. will be significantly impacted if their processes do not meet regulatory standards by the end of 2017. Specifically, all products must carry a Global Trade Item Number (GTIN), serial number, lot number, and expiration date. According to Kurt Wieditz, Director/Team Leader Contract Manufacturing at Pfizer CentreOne, “Because initial serialization projects rarely go completely as planned, expect the total endeavor to take approximately 18 to 22 months.” Could be worse. You could be stuck barcoding Fruit Loops. Here’s the Wikipedia history of breakfast cereals.