Interpack 2014 is the last significant opportunity for many in the pharmaceutical packaging business to gain a global view of the options for item level serialisation ahead of the forthcoming implementation of the EU Falsified Medicines Directive.
Billed by many as the most significant legislative change in the sector in a generation, the Directive mandates that from January 2018, pharmaceutical products will be required to be traceable at item (unit of sale) level via a unique code applied during packaging. Other emerging legislation such as the US federal Drug Quality and Security Act, ANVISA in Brazil and the CFDA in China largely mirrors this theme for item level serialisation.
While the legislation has been on the horizon for some time, many have opted to wait until the final details are clarified before moving ahead with their projects. This, according to Craig Stobie, global life sciences sector manager at Domino, runs the risk of deployments being rushed and potentially not fit for purpose, such is the demand for equipment and expertise as the compliance deadline approaches.
Stobie will be joined on the Domino stand by Ian Haynes of 3C Integrity, Lars Olsen of NNE Pharmaplan and Paul Osborne of Performance PharmaTech, all acknowledged experts in the field. The line-up will be completed by Bart Vansteenkiste, Domino’s European life sciences sector manager.
“Of course Domino has a complete range of pharma serialisation-ready equipment on show at interpack, notably our G-Series thermal ink jet and D-Series laser ranges,” says Stobie. “However, successful serialisation is about much more than simply applying a code: implementation will impact right across the business and through the supply chain, requiring a complete re-assessment of operations.
“It became clear to us some time ago that there is no such thing as a single source solution,” he continues. “We therefore work with a community of experts – including Ian, Lars and Paul – and also a consortium of equipment partners who are working together to define and promote Good Serialisation Practice. With strong representation from all branches of the industry at interpack, it is the perfect forum and we are looking forward to helping to drive forward understanding of this complex area, with some interesting debate along the way.”
Ian Haynes, Lars Olsen and Paul Osborne will be available for drop-in sessions on the Domino stand (Hall 11, Stand D55) between the 8th-9th May and Domino’s pharmaceutical sector specialists will be on stand for the duration of the show. Domino’s Bart Vansteenkiste will present as part of the ‘Serialisation Seminar’ on the 12th May, Hall 8b, Room 814, 1st floor. 2 Sessions are available: 10:00 to 13:00 & 14:00 to 17:00.
Posted on Friday 9th May 2014