“Serialization is important, and we want to do it right. But we’re also worried about budgeting… so where can we cut corners?”
I sometimes get this kind of question in my work. And while I empathize – because serialization is a major, resource-intensive undertaking – it also represents the exact opposite attitude I encourage with my clients. Print quality is a perfect example. With so many other DSCSA items to plan for and coordinate, you might think that saving a little money on print quality is a wise decision.GS1 datamatrix with poor modulation
It’s not, and here’s why: If you’re goal is to meet only the bare minimum of requirements in your serialization efforts, you’re doing your company a disservice – one that could damage your bottom line, and your reputation among partners and patients. And a poor reputation in the health care arena is almost impossible to overcome.
A, B, or C?
The GS1 2D Barcode Verification Process Implementation Guideline explains that 2D matrix printing is graded on a “scale from 4 to 0, with 4 representing the highest quality and 0 is the least quality.” The scale can also be presented alphabetically, A through F, with A as the highest and both D and F as the failing grades.
The U.S. federal requirements laid out in the DSCSA are frustratingly vague: “verification of the product identifier may occur by using human-readable or machine-readable methods.” As with other matters around the details of serialization, the law declined to set a clear standard, putting the burden on the industry.
Other global markets don’t have this problem. The E.U. Falsified Medicines Directive set their standard at C. Easy! Moreover, the EFPIA European Pack Coding Guideline V3_6 shows generous forgiveness of grade D under certain conditions: “The quality of the Data Matrix Code applied to the pack should be primarily grade C or better in accordance with ISO 15415, and printed using ECC200 error correction and will utilise ASCII encoding according to ISO 16022. Grade D codes are not the target quality but can be tolerated in small quantities. “
Not surprisingly, the big three wholesale distributors stepped in with an opinion (just as they have in the past): AmerisourceBergen, McKesson, and Cardinal have all asked for B-level print quality. One reason behind this decision is that B-level print on a label gives them dependable scanability on their warehouse high-speed conveyer belts. A lesser quality would significantly lower that accuracy, and force them to perform manual rescans, which are costly to the business. What’s a Manufacturer to Do?
Many manufacturers – my clients and others – seem to be inclined to choose C-quality printing. There are three reasons for this:
- Setting the standard to B will result in more rejected labels at the factory level because the higher standard creates more opportunity for mistakes
- A higher print quality will mean more print-maintenance costs
- And a higher quality will also mean upgrading printers and inspection instruments – so even more additional costs
But, as the saying goes, one can be penny wise and pound foolish. In other words, small-item budget sense does not always equal good long-term business sense. A modest increase in what you spend on printing will pay off down the line, with:
- Fewer damaged/unreadable returns
- Increased trust in your product thanks to label clarity
When I work with CMOs and manufacturers, there is no one-size-fits-all solution. Every business is different. A lot of things impact a company’s printing ability. That’s why when it comes to implementing serialization, it’s important to talk to a consultant like me who can help you meet all the requirements while balancing needs and budgets. A sound serialization strategy is important for your business, as well as your partners, and the industry as a whole.
How LSPediA Can Help
Serialization implementation requires an organization-wide strategy and careful navigation – one small oversight at any point can end up costing you significant time and money. A trusted partner – to act as advisor and implementation project manager – can make all the difference. And LSPediA is the partner of choice for a growing number of pharmaceutical companies.
The time to begin serialization is now. Starting for as little as $1000 a month, we can give your company compliance piece of mind – and a competitive edge. Contact us today.
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.