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Pharmaceutical Manufacturing and Packing Sourcer

Supplying Success

PMPS: The deadlines for the US and European serialisation regulations are getting closer. What should companies be thinking about now to minimise the impact of the enforcement dates on supply?

Erik Haeffler: With the Drug Supply Chain Security Act (DSCSA) now in play and the Falsified Medicines Directive (FMD) deadline just around the corner, it is imperative that companies press ahead with their preparations. Despite the FDA delaying active enforcement of the DSCSA to November 2018, it can still penalise companies for failing to comply. Serialisation has been vastly underestimated by the industry as a whole, hence the DSCSA enforcement delay, so it is important companies effectively utilise the time they have left to ensure the necessary hardware, software, and operational processes are in place.

Additionally, companies need to look beyond their own preparations and consider the levels of preparedness within their supply chain. Those who work with CMOs need to make sure their partners are investing sufficient time and resources into complying. In some cases, they may need to decide whether it will be necessary to switch partners to ensure continuity of supply after the deadlines. Ensuring a robust network of suppliers is in place will allow companies to not only guarantee complete compliance, but also offset the substantial investment required in terms of time, money, and resource.

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Erik Haeffler is the Vice President of manufacturing services and the Head of CSR at Recipharm. He is responsible for the group’s sustainability work, as well as its focus on operational and commercial excellence. As part of his role, Erik is continuously developing a model for working with multi-site projects and is accountable for operations development across the company, including elements such as project management resources, corporate, and project/product sourcing decisions.

Carlos Machado is Serialization Director at SEA Vision and is responsible for sales, operations, implementation, and post-project support services in the US and Canada. As part of the serialisation initiatives, he is leading the partnership between SEA Vision and Zenith Technologies, implementing its serialisation product suite, focusing on speed to deliver, engineering excellence, and a superior customer experience. In his previous role as Director of Operations at a leading anti-counterfeiting technology provider, Carlos helped to pioneer the serialisation concept and define the future of authentication. He has a wealth of experience in assisting pharma manufacturers with track-and-trace technologies and has worked on more than 75 serialisation projects, from both an operations and delivery perspective.

Dexter Tjoa is Director of Corporate Strategy at Tjoapack. He is responsible for devising, implementing, and evaluating the mid- to long-term strategies of the company and the services it offers, as well as overseeing the commercial, finance, and IT departments within Tjoapack. He has been with the company for two years, during which time he launched Meditraq, one of Tjoapack’s sister brands that offers contract serialisation services. Dexter holds a BSc in mathematics from the University of London, UK, and an MSc in mathematics and computer science from the University of Oxford, UK.
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