PHARMACEUTICAL PROCESSING | SEPTEMBER 2015 17 n
nPHARMPRO.COM n TRACEABILITY
thinking about their external ones. At the same time, most
contract companies are waiting on their pharmaceutical
partners to start the conversation.
Because line upgrades may cost between $250,000 and
$500,000 per line, CMOs and CPOs will likely be looking
for pharmaceutical partner support. Many pharmaceutical
companies, though, will have opinions about whether they
should contribute at all, and how to split financial responsibility with both the contract firms and their other pharma
There is no established commercial model for shared
lines – which partner should pay for how much of each
upgrade – so shared line negotiations will take even longer.
Start these conversations now. Reach out to each of your
partners to discuss needs, negotiate finances and agree on
Negotiating line upgrades is critical, but it’s not the only
thing that needs to be accomplished. The second – and
equally important – component is communication. How are
you passing compliance information back and forth? From
a data perspective, serialization introduces two significant
challenges for pharma companies and contractors: data
volume and data exchange.
DATA VOLUME & EXCHANGE
As serialization requirements phase in, pharmaceutical
companies will need to generate and transmit unprecedented volumes of data to their contract partners. A
pharma company that produces 100 million items annually,
packing 24 items per case and 120 cases per pallet – for a
total of 4,166,667 cases and 34,722 pallets – will commission
104,201,389 individually addressable serial numbers each
year. Assuming that the pharmaceutical company is generating all of these serial numbers, each of those will need to
be sent to the contract partner who is producing and packaging their product.
In addition, for each of these numbers, a range of serialization events – generated, reserved, commissioned, decommissioned, destroyed, as well as potential aggregation
events – may need to be tracked. These, along with their associated serial numbers, will need to be shared between the
pharmaceutical company and their CMO or CPO partners in
order to insure the integrity of the serialization data.
Pharmaceutical companies and their contract partners will
need to determine how they exchange this critical compliance
information. The goal is to insure bi-directional, real-time
data exchange that is tightly integrated with the packaging
processes such that compliance is achieved without compromising operational efficiencies. Doing this electronically with
traditional technology means establishing individual, custom
point-to-point connections with each partner. Or worse, relying on spreadsheets that are manually exchanged.
There is a high cost and level of effort associated with
THE BOTTOM LINE
each of these, particularly since the regulations are still
evolving and frequent changes are necessitated. Also,
Because serialization in today’s global supply network
is inherently a network data exchange problem, it requires
the development of a network data exchange solution.
What is the shared platform that you and your partners are
using? You need to start discussing that as well, and plan-
ning for end-to-end, comprehensive pilot testing with all of
For CMOs and CPOs, the ability to remain a valued partner to the pharmaceutical community hinges on their readiness for serialization. And being ready on-time may also
open up opportunities to win business away from competitors who haven’t planned ahead – turning the regulatory
burden into a competitive advantage. CMOs and CPOs need
to aggressively pursue line upgrade conversations with
their pharmaceutical partners and select an industry-lead-ing serialization platform that the majority of their partners
are likely to use.
For pharmaceutical companies who are working to comply with upcoming deadlines, it won’t be enough to address
just your own internal production facilities. Your outsourced
lines are equally – if not more – important to plan for early.
If your CMOs and CPOs haven’t upgraded in time, you won’t
be able to ship your non-compliant product. That will have
a painful impact on your bottom line, but it could also lead
to drug shortages for patients. Get the ball rolling with your
CMO and CPO partners now, before your competitors get in
line ahead of you and before the deadlines runs out. n
About the Author: Brian Daleiden is Vice President of Industry
Marketing at TraceLink. In this capacity, Brian leads the company’s thought leadership, global regulatory analysis and market
education programs that help industry stakeholders understand
and respond to emerging regulatory, business and technical requirements. Brian holds an MBA from Vanderbilt University and
a BS from the University of Wisconsin.