For the Global Good(s)
With counterfeiting truly a global threat, the pharmaceutical and medical device industries need global solutions. But with different languages and regional rules yet industry desires for common standards, what possible solution could satisfy every stakeholder?
The answer may be in harmonizing product identification. GS1 Healthcare is working toward harmonization on a number of fronts—drugs with medical devices, bar codes with RFID technologies, and among countries. Progress will be discussed at the GS1 Healthcare Conference in Toronto, June 17 – 19.
“Our group has developed significantly,” reports Ulrike Kreysa, director, healthcare. “With the merger of HUG [Healthcare Users Group of GS1] and HLS [Health and Life Sciences group of EPCglobal], we deal now with all standard development in healthcare. The global group is developing standards for pharmaceuticals as well as medical devices, and FDA is involved in our activities. As FDA has the lead at the moment in the Global Harmonization Task Force, it has taken the UDI [unique device identification] initiative to a global level. This is ideal. I am very impressed by the global vision that FDA has for medical devices identification.” Finally, GS1 is working toward interoperability of bar codes and RFID tags. “We are the mother organization for both business units,” Kreysa says.
Standards progress will be welcome news for much of the globe. At this year’s Interpack, for instance, attendees asked exhibitors at the international packaging event about producing and handling track-and-trace data. “Many visitors were interested in how inspection system suppliers were set up to handle track-and-trace requirements, for instance. However, many were unclear of what the requirements or standards may be for their organization,” said Peter Buczynsky, president of Micron PharmaWorks Inc. (Odessa, FL). He spent part of the show with the company’s technology partner, Scanware.
Track and trace was the theme among exhibitors as well. Hapa introduced a hybrid UV flexographic printer that “allows customers to gain the flexibility of printing variable text per blister such as serialization, but still maintain the cost-effectiveness and high-quality print obtained from flexo printing,” says Steve DiAngelis, director, Hapa North America, at Hapa & Laetus Inc. “We also have extended our line of full late-stage customization machines to include color digital label and carton printing, which started last year with the Hapa 807 BlisterJet for digitally printing blisters after the seal and die-cut.”
Scanware presented capabilities of verifying inspected 2-D bar codes and transferring these data onto a network or server,” Buczynsky says. “The data can then be accessed or queried however desired by future track-and-trace software architects.”
With several Interpack attendees from varying countries asking about track and trace capabilities, exhibitors almost felt a growing sense of a global community. “It is apparent that we are an ever-increasing global industry with cultural, logistical, and mental boundaries dissolving exponentially,” says Buczynsky.
So, as talk of meeting California’s now-delayed e-pedigree law fades into that of emerging U.S. laws (think HR 5839), perhaps you could think even bigger—global harmonization.