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Made law last year, the U.S. Drug Quality and Serialization Act adds a serial number to drug packages and labels within four years, and recommends “an interoperable electronic system that traces serialized product at the unit level through the supply chain” within 10 years.
For pharmaceutical manufacturers, “that’s serialization at the smallest unit of sale, serialized cases by 2017 and full aggregation and serialization by 2023,” says Matthew Thompson, a Xyntek company vice president. Xyntek provides serialization and aggregation software solutions powered by Antares tracking system.
DQSA is the start of a U.S. standard for track-and-trace. Its enactment precludes meeting California’s so-called drug pedigree law. Wide variance in international standards will remain. In China and Turkey, for example, the government issues serial numbers for pharma makers to use.
Given the above, serialization was a topic of discussion at March’s Interphex held in New York’s Javits Center. To do serialization, a process manufacturer has to manage its serial numbers globally and deploy them on the plant floor. A vision system confirms the applied data, which must then be shared with the supply chain.
What kind of vendor or supplier best supports those efforts – a printer maker, independent-software vendor or enterprise-system vendor? The printer maker has the shop-floor interface. The ISV wants your business. Maybe the ERP vendor has some basic functionality already.
Companies like Tracelink or Axway can generate serial numbers, “or we can do that for you as part of a system that also generates recipes — what makes up an order and its labeling elements,” Thompson says. “Serialization needs to be managed on its own: print, verify, commission and aggregate.”
The law also gives the Food & Drug Administration authority to regulate companies that compound sterile drugs and ship them across state lines. Compounding used to be the mixing of tailored doses for individual patients. Today it is big business and the very largest “outsourcing facilities” will be regulated by the FDA, but exempt from the full spectrum of regulation.
For manufacturers, the tracing requirements that start Jan. 1, 2015 include provision of transaction information, history and statement in a single document, either paper or electronic, to the initial purchaser.
With all those serial numbers being issued, the ability to print labels on demand will be more important than ever. Other changes to how warning labels must be printed also will make it less easy to pre-print.
Many companies today pre-print color labels and then later a monochrome printer adds any variable data such as a bar code. Falling color inkjet printer-technology cost is making it easier to eliminate this clumsy process that tends moreover to greatly increase pre-printed label stocks.
Kelly Ng, a health-care product manager for Epson says using a printer with feeder and take-up, “you’re able to work in tandem with the ERP system, can serialize batches and run lot or expiration dates,” says Ng. “Plenty of printers have speed and run high quantities, the trick is to do that and custom-printing in an production environment.”
Matt Alldrich, a director of marketing at Videojet points to the out-size importance of the printing function. “Compared to some of your other capital costs, printing likely isn’t a great expense. But if you are not ‘future-proofing’ your printers, you could end up in situations where the inability to print is shutting down production.”