While serialisation schemes around the globe already have much in common, one feature in particular has come to the fore in recent months, and it is not entirely welcome. Following last year’s delayed publication of the Delegated Acts associated with the EU’s Falsified Medicines Directive (FMD), the de facto compliance deadline has effectively moved to January 2019. This news was followed by the announcement in October 2015 that an indefinite halt had been called on Brazil’s serialisation programme, while at the end of the same month, the US Food and Drug Administration (FDA) announced a further four-month delay in enforcement of the track and trace requirements of the Drug Quality and Safety Act (DQSA), which were due to come into force on 1 November 2015.
All this points to the fact that serialisation is proving to be far more complex in practice than had been anticipated – and that the difficulties are being encountered in disciplines hitherto unfamiliar to the pharmaceutical industry. Back in 2011 when the FMD was first published, there was widespread recognition that – insofar as the coding requirements of the Directive were concerned – a large proportion of the installed base was not serialisation-capable. At the time, this was perceived as one of the biggest challenges but taking heart from the successful implementation of France’s CIP 13 programme (which, although not a serialisation scheme in itself, did necessitate updating the coding and vision capability of production lines) many in the industry hoped that investment, however large, in new, serialisation-capable technology would be the biggest hurdle they would encounter.
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