FMD "need not be the enemy of efficiency"

The unit-level serialisation requirement of the EU Falsified Medicines Directive (FMD) is one of the most significant challenges faced by the pharmaceutical packaging industry in decades, but is also presenting new opportunities.

Serialisation could be the catalyst for a sector-wide improvement in overall equipment effectiveness (OEE), according to Domino Printing Sciences' global life sciences sector manager Craig Stobie, who spoke on the topic at last week's Total exhibition in Birmingham.

Stobie and co-presenter Ian Haynes of consultancy firm 3C Integrity gave a seminar at the exhibition at which they shared practical experience from an AstraZeneca serialisation pilot and highlighted the key challenges and opportunities that arise when devising and implementing brand and patient protection projects.

The seminar also updated delegates on the latest global legislation and how the FMD will impact all areas of the sector - from engineering through to marketing and stakeholder engagement, and stressed the time pressure associated with devising and implementing a serialisation strategy ahead of the legislative deadline in 2016. 

"With the European Stakeholder Model based on a timeframe of four years, it's evident that manufacturers face a race against time, particularly when some significant aspects of the legislation - such as who will be responsible for funding the data repository - are yet to be clarified," said Stobie. 

Haynes spoke about the challenge of ensuring a clear and parallel audit trail for the ‘physical asset’ (the product) and the ‘data asset’ (its unique serial number) and emphasised that uninterrupted production is the best possible foundation for robust serialisation. “Poorly-maintained lines will be found out, there’s no doubt about it,” he said.

In closing, Stobie urged manufacturers to take steps ahead of time by speaking to their equipment suppliers.

"There is no 'silver bullet' for serialisation: no supplier is able to supply an off-the-shelf solution so a consortium approach is required," he said.

"Aside from the core serialisation task, however, there is a great deal of groundwork that can be done in terms of ensuring that production operations are in good shape, through equipment maintenance and operator training,  so that when the time comes, full focus can be applied to the complex task of implementing a unique non-predictive serial number," he added.

"It is inevitable that the process will be painful but ultimately we believe that upfront investment in training and equipment will lead to greater efficiency in the longer term."