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Sophie Molle, manager of healthcare industry engagement at GS1, which develops and maintains global standards for barcodes in various industries including pharmaceuticals and foodservice, explains the precise nature of traceability: “Traceability in pharmaceuticals means having the right product at the right place for a low cost in a systematic way.”

Johan Verhaeghe, national policy liaison at Medicines for Europe – the association representing the European pharmaceutical industry – says the data on labels has to be linked to a certain code; so the challenge for companies in their relationship with their packagers is how to securely manage the data.

“In theory, a pharmaceutical company will send to its packager 10,000 codes, and the packager is expected to send 10,000 boxes. But in practice they will send 10,000 codes and receive 9,000 boxes, because there is spill or cancellation.

So the packager has to manage that and has to account for the 1,000 spare codes. The challenge is the management of the data linked to the number of packages that are eventually delivered.”

Perry Fri, Healthcare Distribution Alliance’s (HDA) executive vice president of industry relations, and chief operating officer of the HDA Research Foundation, explains: “The way the industry is pushing forward does not include a centralised database. The large companies in the US refuse to have their data outside their four walls.”

Adents Seriza serialization software enables users to uniquely identify products at all levels of packaging (multi-level – case, bundle, carton, pallet – aggregation) across packaging lines. It covers line and site level appliances and provides high scalability for easy multiple-line, multi-site deployment; easy configuration and a high level of interoperability; and flexibility for centralised changeovers.

Additionally, Solidsoft Reply, part of a software design and implementation network, received Microsoft Gold accreditation and is focused on integration with Microsoft BizTalk and the Microsoft Azure cloud platform. It features a vendor agnostic API and is compatible with legacy systems.

Lauren Catalano, technical services manager at Sharp, the serialisation and traceability specialist, said contract manufacturers in the EU are slightly behind the US in terms of conversion, but Sharp has seen a significant pick up in terms of customer interest and site audits over the last 18 months.

Ian Robinson, director of business development at CMS, says the company has engaged with its clients on a collaborative basis before making any investments decisions. “CMS’s serialisation solution is already in place well ahead of the February 2019 deadline and the company is busy on-boarding their many clients’ portfolios. CMS are keen for their customers to be well ahead of the legislative timeline thus alleviating any risks that may be associated with delays that are being speculated about in connection with the various National Serialisation Databases.”

“It’s no secret that many companies across the pharmaceutical supply chain have underestimated the task of implementing serialisation. As such, they are now looking to outsource the process to CPOs who have the capabilities and expertise to effectively implement and perform serialisation for them.

Allan Bowyer, director of industry marketing, TraceLink, the track and trace software provider for the pharmaceutical market, says the company’s network tenant approach is “unique” in the industry, providing the scalability and flexibility needed to manage serialisation data.

“The EU Compliance module that we created supports reporting requirements from a single platform, so this provides our customers with a tested integration to the European Hub for reporting information about their product master data, serialised product pack data, and status changes for products targeted for distribution across all member states.”

“We continue to be in regular communication with customers regarding their requirements,” says Staffan Widengran, director corporate projects, Recipharm. “To date we have equipped nine of our facilities with serialisation capabilities and our plan is to ensure that 75 production lines across Europe are serialisation compliant. We have introduced new machinery to print 2D codes and human readable text, including serial numbers.”

Additionally, appropriate labelling equipment, which serialises folded cartons and bottles, tamper evident seals, checkweighing, and open flap detection, are also important elements of the FMD. Jörg Willburger, product and project manager track and trace, Bosch Packaging Technology, says: “We have been discussing the serialisation issue with our pharmaceutical customers and with different national and international initiatives for the past years. This has enabled us to develop a solution that matches the different legislations and can be implemented both at pharmaceutical companies and contract packers or wholesalers.”

Emma Williams, marketing manager, Essentra Packaging, tells Packaging News: “Our specialist tamper verification labels – fibre-tear, void and frangible – are FMD compliant, clearly and simply demonstrating when cartons have been tampered with.”