Thierry Protas, global pharma director at Videojet Technologies, looks at the key role coding and marking systems play in serialisation and how best to achieve consistent, reliable results in order to achieve compliance with ever stringent regulations.
VideoJet
With serialisation deadlines fast approaching, a staggering amount of pharmaceutical manufacturers and contract packagers are not fully prepared to meet the stringent requirements for compliance. A number of reports have been commissioned to identify the extent of this issue, with the consensus being reached that some 30- 40% of European pharma companies are not compliant with the Falsified Medicines Directive (FMD) and some 50-60% of US companies not compliant with the Drug Supply Chain Security Act (DSCSA).
This begs the question: why are approximately one third of companies not ready for these major legislative changes? There are a number of reasons, not least the fact that implementing serialisation is a complex cross-functional project. Many departments must coordinate effectively, from production, IT and marketing to engineering and quality, and often a steering committee is required to coordinate activities. To implement such a major change over several lines, or in many instances across multiple plants, is a slow process. This has been exacerbated by end users requesting help from track and trace providers with increasingly short deadlines – creating a bottleneck for the skilled resources available.