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15 May 2018

Serialisation — looking for value-added opportunities

Recipharm's Staffan Widengren, Director Corporate Projects, discusses why CMOs should be focusing on the value-added opportunities presented by serialisation.

The European Falsified Medicines Directive (EU FMD) is just months from its enforcement date. Yet, the industry still has a long way to go if compliance is to be achieved.

TraceLink’s Global Drug Supply Safety and Traceability Report, which includes results from a survey of over 600 respondents, found that 88% of CMOs are concerned that equipment shortages will affect their ability, or their customers’ ability, to comply with the regulations. The survey also revealed that 94% of CMOs felt ‘somewhat’ or ‘very prepared’ for serialisation, yet less than half (42%) had not begun preparing.

Staffan Widengren, Director Corporate Projects at Recipharm, discusses the results of the survey and why CMOs should be focusing on the value-added opportunities presented by serialisation.

Do you think CMOs are right to be concerned about potential equipment shortages in the lead up to the EU FMD?

It’s a legitimate concern, vendors are dealing with significant order volumes and having to prioritize larger customers — lead times from machine vendors have increased significantly from order to delivery in the last year. For a standard machine the lead time today is likely to be over 8 months — Recipharm was working to a timescale of less than 6 months when it started its serialisation program. For businesses yet to select a vendor, they will have to opt for standard machines without customization.

78% of CMOs were already working on value-added projects — why do you think CMOs in the EU are so focused on added-value at this stage?

As the investments required of companies working towards serialisation are so high for a compliance requirement, CMOs are looking for areas where they could gain and add value both internally and for their customers. Developing means of interpreting and utilizing the big data being generated to make improvements in efficiency is a top priority for many.

Why do you think CMOs felt prepared for serialisation despite not having begun any actual preparations?

There’s little doubt that CMOs are aware of the requirement and have begun planning in some way. However, as the serialisation challenge is completely new, there has been some naivety from many businesses and many have failed to appreciate the preparation time required, the lengthening lead times for machines and software from vendors, the complexity of onboarding customers and the difficulty involved in securing approval from top management concerning capex and costs.

Staffan Widengren will be presenting at FutureLink Munich, 5-7 June 2018, on the ‘Final countdown: focus areas for a CDMO before February 2019'.

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