Issue link: https://www.e-digitaleditions.com/i/733311
Nonetheless, companies must manage vendor's lack of capacity, changes to the package and packaging line, iden- tifying lines available for implementa- tion, and data system integration. But perhaps the biggest barriers are organizational in nature. Because the move to track and trace is new, few people are versed in the language or have the skills needed to help compa- nies evolve their operating models. The new models must ensure more effective exchange across the organi- zation and with its partners. Undoubtedly, this will improve over time, but time is of the essence. Desirable solutions for the short and long term Not surprisingly, over the next 2 years, growth in the market for seri- alization services is expected to sky- rocket. As deadlines in the US and EU approach, the landscape remains a legislative labyrinth, and many organizations clearly need help. Meanwhile, the serialization require- ments of many emerging markets have already taken effect or are now being enacted. Domestically, companies are seek- ing partners to help them meet short- term serialization mandates on an expedited basis. They're also consid- ering the long term because what's compliant today won't necessarily be compliant tomorrow. The goal is to identify track and trace solutions that are both ready for immediate imple- mentation and flexible enough to accept future upgrades. To put it bluntly, this stuff is really complicated, it's really crucial, and it's really happening. Promising technologies Thankfully, innovation in the serial- ization sector is booming. New anti- counterfeiting and anti-diversion tech- nologies are already helping thwart illegal activity. Layered technologies that combine overt and covert printed features show great promise. In addi- tion to traditional UV inks, several companies have developed proprietary inks that are easy to add to some seri- alization systems. Beyond compliance, serialization should be an investment that adds value to your business. Vendor selection Keeping your company current, compliant, and competitive requires preparation and careful vendor selec- tion. You need a provider that not only addresses the impact of serialization on your packaging lines, but also con- siders the often overlooked details, such as package design, standard oper- ating procedures (SOPs), warehouse workflow, and re-aggregation. Look for an experienced provider who can minimize the timeframe for implemen- tation, its cost, and the risks. Seek companies with global track and trace experience that can deploy established solutions and balance regu- latory compliance with ease of opera- tion. Ideally, the vendor will provide a solution that works with existing equipment and has the flexibility to meet future needs, many of which have yet to be determined. Fast deliv- ery, competitive pricing, and excellent customer and technical service also are must-haves. My company, Antares Vision, has long anticipated today's heightened demand for top-notch serialization solutions, and has invested in the engi- Tablets & Capsules October 2016 23 Incorporating comprehensive serialization in the pharmaceutical industry Andrew Pietrangelo Antares Vision In any discussion of the complexi- ties of serialization, it's important to focus on the finish line as much as the bottom line. Let's set aside the anxiety- inducing talk of deadlines and guide- lines, of mandates and must-haves. Instead, shift your focus to the ulti- mate goal of track and trace: How it will improve the safety and security of the people who use your products. As your company scrambles to meet pending regulations, it's easy to forget that, in terms of serialization, our overall goal as an industry is admirable and forward-thinking. Not only are we building a safer supply chain, but we're also creating a smarter, more precise and—poten- tially—more profitable one. This process has already begun in Europe, where many companies have a big lead over their US counterparts, not just in establishing serialization proto- cols, but in implementing them, too. US companies are now racing to meet their obligations under the Drug Supply Chain Security Act. That means committing substantial capital and other resources to serialization (track and trace). Like any business venture, if you build a people-pleasing solution, profits will come. Barriers to implementation Let's face it: Implementing track and trace technologies is costly, com- plex, and lacking in coherent or cohe- sive regulatory guidance (Figure 1). Print & Flex Check system from Antares Vision combines laser and inkjet printing, handles 300 cartons per minute, and enables you to adjust all module settings from one graphic user interface. Find track and trace solutions that are ready for immediate implementation and flexible enough to accept future upgrades.