2nd April 2013: Domino Printing Sciences, world leader in coding and marking solutions, has highlighted the challenges pharmaceutical manufacturers will face in meeting the European Union’s legislative obligations of the Falsified Medicines Directive (FMD).
The FMD, which was adopted in 2011 and aimed at reducing the numbers of falsified medicines infiltrating the legal pharmaceutical supply chain within the European Economic Area, will come into force into 2016.
“While some of the requirements of the Directive are relatively straightforward – the provision of tamper evidence for example – others are causing much debate,” says Craig Stobie, life sciences sector manager at Domino Printing Sciences. “Foremost amongst these is the unique identification of packs at item level. While every pharmaceutical pack has been required for many years to carry variable data in some form, the Directive is a significant shift in that data will be unique to each pack rather than to each batch. Much of the coding equipment deployed today is simply not capable of serialisation, meaning that many manufacturers will need to implement a wholesale upgrade of their coding kit.”
Although the fitting of new equipment will vary little from a typical installation, the engineering challenge will be returning to ‘business as usual’ in terms of operating efficiency, says Ian Haynes, co-founder of 3C Innovation and former associate engineering director in the Global Engineering Technology group at AstraZeneca Pharmaceuticals. “Wide scale serialisation projects have been relatively few and far between to date, but anecdotal evidence suggests that the reject re-work level in the early stages can be as much as 10% - far in excess of what is compatible with efficient production. This reduces over time, with rates well below 1% being achievable, but the key thing is it takes commitment, effort and engineering know-how.”
Line speed is also a key consideration, says Stobie. “With more data to be applied, there will be an inevitable impact on throughput. In essence, stakeholders will need to acknowledge that there is a trade-off between production targets and the rate of false rejects. The combination of low running speeds and high reject rates – at least in the early stages of implementation – is a ‘perfect storm’ in terms of operating efficiency.
“It will no doubt be a steep learning curve in becoming fully compliant to the FMD, but there is help in the form of counsel from your industry suppliers and from industry peers who have led the way,” continues Stobie. “Furthermore serialisation may provide opportunities for improved patient engagement, and has the potential to provide a powerful tool to facilitate improved adherence and patient experience – a huge benefit for the entire pharmaceutical industry.”
Posted on Monday 18th November 2013