Issue link: https://www.e-digitaleditions.com/i/977310
Tablets & Capsules May 2018 13 there are some smaller manufacturers that are still identi- fying and implementing systems with very little room for error to meet the deadlines. Are there aspects of serialization that companies tend to overlook or underestimate? Duffin: We see many companies underestimating the overall impact of the changes on their manufacturing operations. The new systems require extensive training and revisions to current processes. A new mindset is required now that every product on the line is unique. Tjoa: I think when the legislation was announced, companies said, "Okay, we just need to print something on the box." A lot of companies focused on the machinery on the shop floor and how to install a printer on the line, etc. The biggest challenge of serialization is actually the data-management aspect, which many companies have overlooked or put off until further down the line. Software service providers have brought out solutions, so compa- nies can buy the software, but they also need to design their processes around the fact that sharing data is now going to be part of how things have to run. I think compa- nies are struggling with that aspect and may have underes- timated the additional process design work that goes along with serialization. Jean-Marie Aulnette, vice president for Europe, Middle East, and Africa sales, TraceLink: There is a lack of understanding of the complexity and resource inten- siveness of serialization. The implementation process is With less than a year remaining before companies must comply with DSCSA and FMD serialization requirements, how are pharmaceutical companies and CMOs progressing? Staffan Widengren, director corporate projects, Recipharm: I would say the industry is prepared but not to the extent that it should be. A lot of brand owners are not ready. Some companies may be underestimating the workload, and some may not have the financial means to invest in serialization. I think they know that if they're going to do this they need to invest and if they don't do it now, it will be too late, because the lead time for equip- ment is greater than 9 months. Also, some CMOs may not continue to package and will contract packaging and serialization out to an external company. Dexter Tjoa, director of corporate strategy, Tjoapack: I think the general consensus is that the indus- try is progressing very slowly. There are still quite a few companies struggling to figure out what exactly they have to do to comply with the US or European regula- tions or both. Most companies have made some sort of move and have set up a serialization program, but I think the general state of readiness is behind schedule. John Duffin, president, Clarke Solutions: Most of the industry is progressing well and is ready for the initial requirements of unique identification at the unit of sale, but for the 2022 and 2023 aggregation requirements in the US, there is still much work to be done. Larger CMOs and CPOs are either ready or nearly ready, but