Our very own Christoph Krähenbühl is one of the Serialization Gurus who spoke to the Medicine Maker last month.
The magazine wanted to talk to six track and trace gurus and understand how ready the industry is to meet the serialization deadlines. Medicine Maker have kindly given us permission to share the questions asked and snippets of Christoph’s answers:
People first started seriously talking about serialization in the pharma industry around 2005, when the focus was very much on stopping fake drugs. Ultimately, I believe that putting a unique serial number on each package and verifying it against a securely kept database is a powerful tool for preventing counterfeits, fraud and theft, but serialization also opens up other opportunities too.
First of all, we have learned much about the technology itself…The other key lesson is that one size does not fit all: this is a widely diverse industry in terms of size, complexity, and area of activity so putting the right solution in place in the right way is critical.
Serialization is as big as an enterprise resource planning (ERP) project – potentially bigger. Getting the whole organization involved and keeping it involved is actually quite a challenge. You need to get your senior stakeholders on board – and then you need to keep them on board!
With every customer we’ve worked with, we often find they have a lot of homework left to do, like the fact that their product master data may not include the product codes that are now part of the pre-printed artwork… many companies have trouble getting their head around what the full program scope includes, as well as how to get it up and running.
Serialization is not a perfect solution, but there is no perfect solution. It is always a trade-off between the cost and complexity of the countermeasures you put in place, versus the effect they will have. Serialization means that, in a pharmacy context for example, the checkout will be very secure.
In the short-term the industry will take a hit, there’s no doubt about that – after all, serialization involves considerable investment. On the other hand, this creates opportunities in the short-term for the companies that have got their act together early on, and puts them – and the rest of the industry – in a position where they will be able to reach the bigger benefits alluded to before.
To read the article in full visit https://themedicinemaker.com/issues/0817/whats-on-the-box or contact GetSecured@3CExcellis.EU for more on how we can help you get ready.