off will help to focus your efforts. It’s also important to develop
a comprehensive program roadmap, outlining timelines, key
milestones and deliverables.
5. People power
Establishing a dedicated taskforce to drive your serialization project forward makes sense for most organizations and clearly defining who will lead the group is critical to ensuring proper governance. Ensure team members understand their role and how
much time they need to dedicate to the program outside their
core job functions. Determine if you have a serialization subject
matter expert (SME) in place and if not, seek out an SME from a
consulting company. Remember to engage vendors and implementation partners as part of your serialization team, leveraging
their track record and expertise. This will maximize collaboration
and implementation effectiveness.
6. Future proof your serialization set-up
From November 27, 2017, manufacturers supplying drug products in the U.S. must affix or imprint a human interpretable and
unique standardized numeric identifier (SNI), packaging lot
number and expiration date on each drug package and maintain records of this data for six years. However, this is just one
step in securing the pharmaceutical supply chain and protecting against counterfeit medicines, with subsequent updates to
guidelines to follow.
From November 2018, repackagers must also encode drugs in
the same way as manufacturers. From November 2019, wholesale
distributers will only be able to engage in transactions involving
pharmaceutical products that are encoded with the SNI, pack-
aging lot and expiration date required of manufacturers and the
same requirements will apply to dispensing organizations from
November 2020. In fact, it is not until November 27, 2023, ten
years after the enactment of the DSCSA, that full track and trace
requirements will come into force.
The message here is to be prepared for evolving regulatory
requirements and take a forward-thinking view. Many companies in the U.S. are already taking the 2023 deadline into consideration and implementing technologies and processes with the
flexibility to adapt to new requirements. For example, it is likely
that aggregation will become mandatory in some markets, creating more complex data exchange challenges. Build this capability
into your solution now, to save time and money in the future.
In the U.S. it’s likely that only 70% of small contract manufacturing organizations (CMOs) and CPOs will be ready for the DSCSA
requirements. As such, it’s important that companies preparing for
the EU FMD don’t make the same mistakes. Prioritizing serialization within your business is critical to meeting the 2019 deadline
and key learnings from the U.S. include the importance of internal
communication, a comprehensive project management approach
to implementing changes and the need to think to the future.
Those organizations that take a short-term view when implementing new technologies and processes risk not maximizing the return
on investment. Take the opportunity to refine and improve your
business operations and you’ll experience the benefits of your serialization efforts for years to come. CP
CARLOS MACHADO is serialization director for EA Vision U.S. where he is responsible for sales, operations, implementation and post project support services in North America. As part of the serialization initiatives, Carlos is leading
the partnership between Sea Vision and Zenith Technologies implementing its
serialization product suite, focusing on speed to deliver, engineering excellence and a superior customer experience.