Though the principles of serialization are fairly straight forward, there’s more to serialization than just generating numbers. Especially in the tightly regulated and compliance-led world of pharmaceutical manufacturing and packaging.
First, you can’t afford to be random about random numbers. While it is not difficult to create a few thousand different numbers, the reality is that even in a particular batch you could need a hundred times that. Across multiple product lines and over a period of years it could amount to many million. Any solution must be scalable and sustainable.
The very nature of randomization means that numbers can be unintentionally repeated which would seriously compromise the reliability of your system and potentially endanger patient safety. Generating and managing unique numbers requires a highly robust and validated solution.
It is further complicated by the fact that you could have a serial number for one product that is the same for another product. This raises the most fundamental issue surrounding serialization. How you manage and administer number generating and allocation and what’s the best approach to keeping it both logical and simple?
Want to know more? Why not download the entire white paper from PrisymID , also leave a comment below add your insight and your experience in this area, we love to hear from you….
Excellent whitepaper! There is a huge misunderstanding in the US marketplace that since Serialization is not yet required by law and because there are no set standards Serialization is not yet a necessary initiative. Starting a Serialization initiative now is both morally and financially responsible. It has both hard and soft benefits and it provides a migration path to any compliance standard in the future.
Obviously, having a tighter supply chain has an obvious ROI especially in terms of shrinkage and returns. But the soft benefits are where a company can realize astronomical and often immeasurable returns. The global threat of counterfeit drugs is obviously already out of control. It hurts the brand, the creditability of the company, it takes money directly out of the pockets of each and every employee of the company and it hurts the community. Counterfeit drugs are essentially mass murder and economic terrorism. There is also the threat of lawsuits from the customer it hurts. Already, the US has seen the first court case brought against two drug companies for allegedly failing to act to protect customers over fake drugs. Both companies settled out of court, apparently for US$72 million.
There are already customers in many less developed countries who do not trust certain brands of drugs as a result of counterfeits and this has happened here in the US as well. Much of what is purchased online here in the US from “so called” Canadian online pharmacies are counterfeit. In fact, over 50 percent of the shipments coming into the US from online drug sales from these companies that call themselves Canadian based are actually coming from South America, China, Pakistan and several other places that would surprise you. And ~23 percent of these drugs are counterfeit! The origins of these drugs are often rogue countries such as the DPRK.
Organized crime syndicates, drug cartels and even terrorist organizations have turned to this lucrative market because of the simplicity of making fakes, the low risk of getting caught and the lax penalties. As an example, counterfeiting money in China is punishable by death while counterfeiting drugs has a maximum fine of 500RMB (~$73.00 USD) – all this at the expense of our company’s brands, our drug discovery, the money it steals from our economy and of course the consumer that it often kills.
Fake drugs have become more deadly than terrorism. Forty years of terrorism has killed ~65,000 people, compared with ~200,00 in one year alone in China from counterfeit drugs. This is obviously an important topic and we can no longer “wait” for the FDA or anyone else to tell us when we should do this – As i said, starting an initiative now is both morally and financially responsible.