Serial Indecision

2016 is a pivotal year for serialization in the pharma industry. Serialization requirements are already in place in South Korea, China and Saudi Arabia, and the deadlines are fast approaching for the US (2017) and Europe (2019). Time is short. Is your serialization strategy in place? Have you selected your solution provider? Have you started to make the necessary changes to your packaging lines? A general urgency is pervading the industry, but many key decision makers have told me that they are finding it difficult to identify the right solution. And the profusion of products now available means the task is getting harder by the day.

Recently, I met with the head of engineering of a contract manufacturing company who was in the process of researching and evaluating track and trace solutions. He started the discussion by saying, “This is a market of dream weavers.” It struck me as a very apt comment. There are indeed many solutions to choose from, and whether they prove sweet dreams or lingering nightmares isn’t always difficult to assess.

Many serialization technologies are proprietary solutions developed by companies that have traditionally focused on inspection systems. Serialization may seem like a natural progression for such companies, but in some cases solutions have been developed opportunistically by piling on layers of features and software as customer and regulatory requirements have evolved. As a starting point, let us look at how serialization has evolved:

• The first phase of serialization was to print and register/record a string of characters and a Data Matrix 2D-barcode onto the drug carton.
• The second phase was to print and register/record data that vary from one carton to another. It required the printing device and camera to be fast enough to handle new data for each carton.
• The third phase was to develop software to manage the serialization process locally on conveyors. Such conveyors soon became mark and verify machines dedicated to securing the printing process on the packaging line. Suppliers saw a clear opportunity to add value into these machines by embedding software that generates, transmits, checks and captures unique codes, as well as ejecting drug cartons in instances of defect.
• The fourth phase was to connect several mark and verify machines to a central server to store line data at plant level and to exchange data with the organization-wide IT infrastructure.

This current phase is what I call a bottom-up approach because it addresses related needs individually, starting with the existing production environment. In the short term, this approach is passable, but its reactionary nature means it is more patchwork than progressive, which calls into question whether such a solution will be fit for future requirements. Serialization solutions must be flexible enough to cope with the needs of the future. For example, although coding systems, such as GS1, IFA and the Health Industry Bar Code Standard have standardized barcoding specifications, they are not harmonized. There will be a time, in the not-so-distant future when all serialization systems will need to be able to “play nice” with each other under one overarching regulatory umbrella, which means that companies currently incorporating serialization into their production lines need to be looking for systems that will be universally compatible.

At the moment, each regulator specifies their own data pattern, but the choice of the coding system is up to the drug manufacturer (or the member state within the EU-regulated area). Most, but not all, select the GS1 standard; Germany, Austria, China and a few US manufacturers are notable exceptions. Serialized codes can be either imported or generated on site, and there are several methods to generate unique codes (random or algorithmic). Each Marketing Authorization (MA) holder can also add new requests to the previous pattern, which allows for additional, more customized information to be logged, stored and shared, and request a specific format for the serialized batch data export file.

What does all of this mean? It means that pharmaceutical manufacturers and contract packagers must be able to set-up, exchange and store thousands of data format combinations over time – a process that requires flexible, configurable tools that can generate and exchange massive volumes of data, all while managing manufacturing processes in real time. Many companies are not prepared for the complexity that serialization involves and tend to favor vendors who have previously supplied them with relevant machinery to, for example, print batch data on drug packs. This is an easy and convenient approach, but it shouldn’t prevent you from looking at other options too. On the hardware front, serialization is relatively straightforward – nowadays, all machines can mark and verify 2D codes securely. The more complex part is the software and rolling out a serialization solution is a large-scale, global issue unto itself. For some vendors with a wide portfolio of equipment, however, serialization is just another column in their product portfolio. In my view, it is better to find a true expert who focuses only on serialization – they will be dedicated to the cause because, quite simply, their livelihood depends on it.

Ideally, I advise users to look for software that is specifically designed for global serialization. Obviously, given the approaching deadlines, you need to consider deployment lead times and changeover efficiency, but don’t forget about the future – find out about how easy it is to implement changes and upgrades to meet future requirements. And most importantly of all, when in discussion with any vendor about a serialization solution always ask for proof of the claims they make – to make sure you’re not just falling into a woven dream.