SHOCK AND DENIAL
Every conceivable rationalization about postponing DSCSA
compliance was put forward by manufacturers, CMOs, wholesalers, distributors, LSPs, CPOs and every other affected business. “The wording is too vague.”“We are waiting for further
FDA guidance before we start.”“They will never enforce.”“It will
After so many board meetings about the subject that participants could have talked their way around the world twice, most
manufacturers graduated to the next stage towards serialization
enlightenment: anger and bargaining.
ANGER AND BARGAINING
Anger isn’t productive, so let’s cut to the bargaining. Like children attending nursery school one
year and graduating college
in the blink of an eye, the
first FDA deadline passed in
2015 and time marched on
until today when we are at
the threshold of the upcoming second legal milestone
on November 27, 2017.
In the interim, an entire
industry of pharmaceutical
serialization enablers has
risen and partially fallen as
companies interviewed and
negotiated with them to
achieve DSCSA compliance
within the allotted timeline.
In another study, it was revealed that confusion surrounding the selection of
technology partners is the
single biggest factor hampering industry compliance. 3
Before everyone mentions the recent FDA draft guidance
delaying enforcement of DSCSA regulations for one year until
November 27, 2018, most experts agree that’s a red herring. It
was widely recognized that 100% compliance was not achievable by the set deadline. The Law requires an Act of Congress
to change. Unless that happens, law-abiding entities are still
required to serialize by the set date—November 27, 2017. Law
enforcement and legal statutes are different things. Look at
it this way. Many people jaywalk. Few are ticketed. Until the
Manufacturers that have postponed serialization plans until
this point or that cannot justify the cost/benefit equation based
on their business size, can leap forward to serialization compliance by working with select logistics services providers (LSP) that
These companies, including WDSrx, a pharmaceutical LSP
with contract packaging capabilities, utilize their completed
serialization platform and make it simple to take in non-seri-alized product, re-package and re-label to DSCSA-compliant
specifications and even fulfill orders to trading partners in the
U.S. and in Europe with fully compliant data transmission.
ACCEPTANCE AND RENEWAL
Now that the shock, anger, denial and excuses are almost all exhausted, manufacturers are beginning to glimpse the light from
the otoscope at the end of the ear canal.
Hello acceptance and renewal.
At this final stage of the serialization cycle, the prepared
manufacturer casts an eye beyond the nuts and bolts of physical serialization and focuses on performance metrics in the post-serialization world compared to the old days.
THE DIGITAL FACTORY
Many benefits result from the considerable investment required
to achieve DSCSA compliance. First and foremost, a safer pharmaceutical supply chain further protects patients from adulterated drug products. In
addition, a few ground
breaking consulting firms
are inviting manufacturers to see beyond serialization and make further
to create a truly digitized
These companies, including Supply Chain
Wizard based in Princeton, NJ, are transforming conventional packaging operations into digital
factories with technology
that constantly analyzes
data to improve workflow
and increase efficiency. Information and analysis is
displayed in real-time on
an intuitive touchscreen interface.
The data evaluation results in actionable recommendations that improve productivity across every operational area
from production planning, scheduling and labor costs to
record-keeping and reporting, packaging and overall equipment effectiveness.
The logic for manufacturers to establish digital factories is
based on the significant investment needed to meet serialization
requirements. The considerable one-time and ongoing costs for
replacement, upgrade and maintenance of equipment, hardware,
software and training will only realize their full potential with a
further incremental investment to increase the efficiency of these
components. That is the idea behind the digital factory.
REVERSE PRODUCTIVITY LOSS FROM DSCSA
The additional time, labor and equipment needed to convert conventional packaging lines to meet DSCSA guidelines will likely
result in productivity loss. Analysis has shown up to 30% reduction in overall equipment effectiveness (OEE) in some cases. This
productivity loss can be substantially reduced and even reversed
in the digital factory.
Manufacturers must assure serialization efficiency is pursued everywhere within the supply chain.
DSCSA compliance affects cGMP guidelines and training techniques. (courtesy of WDPrx)