Serialization has been an industry hot topic for a long time and despite the extensive build up, a lack of readiness among supply chain companies has led to the Drug Supply Chain Security Act (DSCSA) enforcement being delayed by
a year. But what does this new deadline mean for the industry?
And, what opportunities does it offer pharmaceutical companies?
This article will discuss what those who were underprepared
should be doing to implement a suitable solution before the new
enforcement date arrives and how well-prepared companies can
utilize this time to achieve wider business benefits.
A SECOND CHANCE
The announcement that the enforcement of the DSCSA regulations will be delayed did not come as a complete surprise.
Many companies failed to recognize both the urgency and the
scope of the task at hand and as a result have been unable to
meet the requirements in time.
Serialization is not as simple as it sounds. The scope of
implementing serialization across packaging lines goes far
beyond introducing a barcode. Solutions need to be fully inte-
grated across business operations to ensure minimum disrup-
tion to supply and with varying market regulations to contend
with successfully implementing serialization is a steep learn-
Beyond this, each individual drug product will have its own
unique identifier, as well as other product information, such
as expiry dates, within its barcode and all of this data needs
to be recorded in a level 4 system. Companies then need to be
able to transfer the mass amounts of data generated because
of serialization, safely and securely.
In short, the considerations surrounding serialization are
extensive and it is essential that those involved in the supply
chain recognize this. While this extra time is a welcome reprieve for a lot of supply chain partners, implementing serialization remains a time sensitive task. Companies should now
seize the opportunity this delay offers to ensure they are fully
compliant come the new enforcement date and the looming
EU Falsified Medicines Directive (FMD) deadline.
The DSCSA Delay
What Does it Mean
for the Pharma Industry?
A look at what companies should be doing to implement a suitable serialization solution
before the new enforcement date arrives
Erik Haeffler, Vice President