Understandably, in the early days of serialisation in the pharmaceutical industry, the late
2000’s, the technology available and the supply base providing it were, by and large, relatively immature.
In the intervening years, whilst a significant amount of serialisation legislation has been passed and millions of packs have been serialised, the supply base and technology in 2015 is still not as mature as one might hope for.
Of all the technology areas, the technology necessary at the packaging lines is probably the most mature, with a number of well-established suppliers offering robust and proven solutions. However, a word of caution in this area is that many of these organisations are relatively small businesses. Their scalability to meet the inevitable increase in demand over the next few years must be carefully considered by potential customers.
Unfortunately, serialisation solutions at the enterprise level are not yet at the same level of maturity as line solutions, even from vendors who sell both solution sets. This appears to be because of two main factors. Firstly, the reality is that in recent years, many organisations have implemented tactical serialisation solutions not requiring full strength enterprise level implementations. Secondly, to be fully mature, solutions need to cater to both the normal and abnormal business scenarios. Regrettably, there are very few countries, if any, where all these issues have been resolved. Therefore, the solutions offered by the supply base have, in general, not had the standards in place, nor the number of end-to-end supply chain implementations necessary to develop what many would consider to be mature products.
Having said that, industry and standards’ bodies are still working to define how serialisation will operate in many of these abnormal scenarios and/or particular situations. Knowing this, when entering into any relationship with vendors in this area, it is best to assume that the solutions are not fully developed and that issues will crop up that, in a mature environment, you might expect to have already been resolved.
I hope you enjoyed this instalment on Things we wish we had known before starting a serialisation program or project. Please check back in next week for the continuation in this series.
Should you have any questions about this or any other of my blogs, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.