In February, China’s State Food and Drug Administration (SFDA) announced its implementation of a national track-and-trace strategy, leaping ahead of the United States in national serialization efforts. The agency felt its current good supply practices (GSPs) weren’t on pace with the rapid growth of China’s economy and society, not to mention evolving drug regulatory and pharmaceutical distribution requirements. Regulators revised the GSPs to provide much-needed clarity through a three-year implementation plan that begins June 2013. So, what do these provisions mean to U.S. and global track and trace endeavors? To find out more, I talked with Michael Stewart, VP of track and trace projects for PharmTech, Inc., a consulting group which has been involved in serialization projects with pharmaceutical manufacturers since the development of the California ePedigree mandates.
“Although we applaud China for taking measures to safeguard their pharmaceutical supply chain, now the global discussion should not be whether item-level serialization should occur, because that’s a given,” Stewart explained. “Rather, the questions that should be asked are: What are we trying to accomplish? Is ePedigree or authentication the end goal, and why?” For example, in the United States and California, ePedigree essentially identifies counterfeit drugs that have infiltrated the legitimate supply chain and eventually tracks where they were introduced into the supply chain and by whom. Unfortunately, that doesn’t always solve the problem. This is where China’s authentication methods come into play. The authentication process checks the validity of the serial number at the point the drug is dispensed to the patient, not during its travels. Wouldn’t the best solution be a hybrid of both, where fake products could not enter the supply chain and also could be detected at the point of dispense? Sure, but Stewart emphasized that “we need to ensure that the cost of the solution is not more costly than the problem.”
You can read more of this article, as well as other articles concerning serialization, in Pharmaceutical Online: The Magazine — when it debuts at INTERPHEX 2013 ! We’ve focused this issue on important aspects of product protection through a track and trace system. You can look forward to a step-by-step breakdown for serialization implementation from now through January 1, 2015, read insights from Dirk Rodgers from Rx Trace, and find tips on how to be a better project leader — just to give you a little taste of what to expect.
Since the California ePedigree law deadline is now less than 21 months away, track and trace should be top of mind and planning needs to start at your company, if it hasn’t already. INTERPHEX is also on top of the issue, featuring a mini-course on serialization. I’m particularly looking forward to hearing what experts in the field have to say about item-level implementation, process improvement, and the economic impact of serialization. (you might want to add this to your “Registration” before you attend!)
And, as you are visiting the exhibition hall, be sure to stop by the Life Science Connect booth #4117 and pick up a copy of the magazine. And, look for follow-up interviews and videos from INTERPHEX on Pharmaceutical Online after the show!
By Lori Clapper, editor, Pharmaceutical Online