Serialisation: a new challenge with new and specific requirements

TraceLink recently launched its Global Drug Supply, Safety and Traceability Report, which included the results of a survey of more than 600 industry professionals regarding upcoming track and trace regulations

Manufacturing Chemist asks Paul Andreianu, quality assurance Manager at Leadiant Biosciences and Head of the company’s serialisation programme, about some of the key findings in the Global Drug Supply, Safety and Traceability Report and why pharma companies should be searching for third-party specialists to tackle the serialisation challenge.

Of pharma companies that need to comply with the EU Falsified Medicines Directive (FMD), 30% have already hired additional staff dedicated to serialisation, compared to just 9% of those looking to meet the US Drug Supply Chain Security Act (DSCSA) at the same point last year.

MC: Do you think pharma companies should look to third-party specialists to fill resource gaps or recruit in-house? Why?

Andreianu: Pharma companies should be looking to third-party specialists when it comes to serialisation; it’s a new challenge with new and specific requirements. The regulatory element is handled on a project-by-project basis as new laws come into fruition, meaning some flexibility when it comes to expertise and resource management strategies is a must.

MC: Just 27% of respondents believe that they will be sending serial numbers to the EU Hub by the February 2019 deadline, why is this the case? What are the main barriers preventing pharma companies from doing so?

Andreianu: There are various factors causing concern around readiness for sending serial numbers to the Hub. Firstly, there is the limited transparency and mixed messages coming from the various National Medicines Verification Organisation in relation to the EU Hub, their National Medicines Verification Systems (NMVS) and the European Medicines Verification Organisation (EMVO).

Andreianu: A good example of this is the role of the On-boarding Partner Portal (OBP), which is still being updated with much needed features. Secondly, due to the nature of EU law that allows each member state to have its own interpretation of the Falsified Medicines Directive (FMD), we currently face a lack of standardisation across the Union – this adds layers of complexity that leads to additional implementation time for businesses active in multiple countries.

94% of CMO respondents felt somewhat or very prepared for serialisation yet 42% had not begun preparing.

MC: Why do you think CMOs felt prepared for serialisation despite not having begun any actual preparations? Do you see any of this disparity with your CMOs?

Andreianu: A ‘normal’ implementation time is between 6–9 months, depending on internal resources. While the deadline is looming, most CMOs will have begun preparations, selected and contracted suitable vendors and undertaken detailed planning before implementing their solution. There is an old saying ‘measure twice, cut once’, CMOs are ‘planning twice, implementing once’ and on top of that most of them had an early start, realising the importance of FMD and the effort to fulfil all requirements.

Paul Andreianu will be speaking at FutureLink Munich, which will take place 5–7 June, 2018.

The event will see leaders from across the pharmaceutical and healthcare industries gather to discuss regulatory compliance and shaping the future of digital drug supply with information sharing networks.

For more information and to reserve a seat, please visit FutureLink Munich.

The full 2017 Global Drug Supply, Safety and Traceability Survey Report is available here.

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