Six months and counting


With 6 months to go until the DSCSA serialisation enforcement deadline kicks in, Manufacturing Chemist caught up with some leading lights in the industry to find out how companies were shaping up ahead of November to mark the occasion

Six months and counting

Colin Newbould, Director of Regulatory Affairs and QP Services, Wasdell, commented: "With 6 months to go until the US DSCSA enforcement day, companies should really have already implemented a clear strategy for compliance."

"Those who have not will now be struggling to acquire the necessary equipment and delivery lead times, which will inevitably get longer in the last-minute rush."

Such organisations need to consider how long it will take to not only test solutions to ensure they work efficiently, but also to test lines and implement the necessary changes to packaging components."

"For example, cartons will need to have unvarnished areas added to cater for new lines of text such as GTIN, batch number, expiry dates, serialised data and 2D data matrices."

"Tamper evidence measures also adds a level of complexity, for example, will these be covert or overt? In addition, packages that include braille will need to be adapted to cater for these systems."

It is these complexities that are leading many companies to look for third-party contract providers to outsource their serialisation requirements.

Those sourcing new partners should be looking for contract organisation that has already implemented serialisation systems from level 1-4. They should also be doing this soon to not only ensure compliance with the US DSCSA, but also the EU FMD in February 2019.

"All companies should have an action plan in place, with launch dates to start serialising packs scheduled as soon as possible for the US DSCSA and at the latest for Q3/Q4 2018 for the EU FMD," he concluded.

Dexter Tjoa, Director of Corporate Strategy, Tjoapack, added: "With just 6 months to go until the new US DSCSA enforcement date, time is short."

"Those companies that have not yet developed an in-house solution are realizing that employing contract service providers, which are well-prepared for new serialization legislation, is a viable solution to tackling the now very tight timescales and ensuring continuation of supply to market."

"However, companies looking to outsource their serialisation requirements really must act now. As the deadline gets closer, contract packagers will begin to get busier onboarding existing customers."

"New customers need to bear in mind that their partners will need at least 4 months to ensure approval of artwork and packaging protocols and design a suitable solution."

"In addition to the normal process for new product integration, such as storing and managing product master data and master packaging records and designing the packaging artwork, business leaders need to think about software integration for exchange of serial numbers, connection validation and test runs."

"Any further delays to engaging outsourcing partners could result in non-compliance and, ultimately, delays to market and stock shortages."

Staffan Widengren, Director Corporate Projects, Recipharm, said: "With only 6 months to go until the active enforcement of DSCSA, there is little time left for manufacturers to implement any real changes."

"Vendor availability and third-party resources are almost non-existent at this stage as early movers and more organised businesses have already secured support."

"Companies across the supply chain should now be increasingly focused on onboarding and finalising the connections with their partners and customers and validating their solutions."

As a CDMO, we encouraged our customers to onboard sooner rather than later to ensure a smooth transition come the deadlines."

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"We are also exploring ways to offset the costs of introducing a level four system for companies with only a couple of SKUs as cost remains a major barrier for many when it comes to implementation."