Just 526 days. That’s how far we are from the “new world” of pharmaceutical serialization in the U.S. For anyone who thinks that sounds like a lot of time, take it from the consultants (like myself) and manufacturers who have been through the process when they advise you to take advantage of every one of those days. Because there will be unforeseen obstacles and delays. At this point, time is as important as any gap analysis, project plan, or technology update (and, of course, we provide all of those and more to our clients). A couple of extra months in your timeline could be the thing that bails your company out of a tight spot – and it will be cheaper than trying to fix a problem with the November 1 deadline – and non-compliance fees – hanging over your head.
After attending an HDMA webinar last week I became even more convinced that starting serialization early is the single best piece of advice for manufacturers. Let’s find out why.
AmerisourceBergen Shares Insights and Best Practices
The webinar was called “Preparing for Serialization,” and it offered presentations from several industry insiders on the topic of barcoding and labeling. While they were all enlightening, I want to focus on the AmerisourceBergen portion, as they offered some early reviews on what serialization looks like where the rubber meets the road – with the distributor.
- Good labels share some common traits. First off, they’re encoded to GS1 standards and printed in print quality A, B, or C. Also, the human readable information (HRI) is easy to locate and positioned close to the 2D barcode, speeding and simplifying identification by scanners and people. They also pointed out that a good label eliminates potential returns issues, which is very important given their worry over saleable returns.
What’s Not Working
- Not all labels are created equally. AmerisourceBergen is seeing a wide variety of label styles and qualities. As usual, that lack of uniformity is creating problems. The webinar pointed out that there are issues at every packaging level, including unit, bundle, partial bundle, case, partial case, and pallet. Wholesale distributors receive millions of shipments a day, and automated, standardized receiving processes help them get the job done efficiently. In the serialization world, a small amount of label inconsistency throws that supply chain efficiency out the window.
- Bad labels are bad in unique ways. It sounds like there are lots of bad examples to choose from, including incorrect coding in labels, labels falling off of products, labels missing HRI altogether, and some manufacturers using National Drug Code number (NDC) instead of a Global Trade Item Number (GTIN) in the 2D barcode.
- 1D/2D barcode troubles. Moving from a one dimensional barcode to scanning a two-dimensional Data Matrix barcode is creating additional challenges for the distributor – for example, not all scanners are reading the 2D codes correctly. They also noted that some GS1 compliant 2D barcodes were readable with a smartphone, but not by their $2500 scanner. They stressed the need for proper grading and QA testing at the packaging site.
- Case label problems. Where on a package you stick your label might seem like an inconsequential act, but AmerisourceBergen is discovering that placement is critical. They found many labels have sustain damage during shipping, especially those placed on the edges or corners of boxes. They recommend using a corner-wrap label with two mirrored images rather than identical images, therefore placing the barcode away from the corner.
Serialization execution is full of complexities and challenges, such as a label that looks good to you but causes a major mishap at some point down the supply chain. All of these kinks need to get worked out, or manufacturers and suppliers risk returned shipments.
Meeting Serialization Compliance – With LSPediA
You only have 526 more days – so the time to act is now. By calling us today, I can ensure you get the serialization and labeling help you need.
Through our suite of solutions – including Serialization Toolkits, CMO Management, Compliance Services, Technology Services, and others – LSPediA is helping pharmaceutical manufacturers large and small:
- Meet DSCSA compliance deadlines with proven serialization methodologies
- Lower overall serialization spending
- Mitigate compliance risks with comprehensive, gapless coverage tailored to your specific needs
- Shorten project timelines by removing trial-and-error from the process
Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact me today. Working together, we’ll develop a customized LSPediA Services plan that’s just right for your business.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.