n 16 SEPTEMBER 2015 | PHARMACEUTICAL PROCESSING
nPHARMPRO.COM n TRACEABILITY
As the Life Sciences supply chain has shifted from predominantly local to increasingly global over the last decade, many pharmaceutical companies have virtualized up to 70 percent
of their production and packaging in order to be successful
in new markets. They have built relationships with local
contract manufacturers and pharmaceutical companies for
production and distribution efficiencies, allowing them to
capitalize on the global market by cost-effectively producing
and distributing product around the world.
However, the last decade has been marked by increasing
drug integrity concerns, prompting more than 40 countries
to introduce track-and-trace laws to help regulate product
as it passes through the supply chain. By the end of 2018,
it’s estimated that more than 75 percent of the world’s prescription medications will be protected by legislation.
For the industry, these regulations introduce a web of
challenges, as most regulations mandate:
• Some combination of generating and managing serial
• Exchanging data in diverse formats with trade partners.
• Tracking product through the supply chain.
• Verifying data.
• Reporting associated events to government authorities.
Serialization deadlines are fast approaching in three key
• Brazil Phase One in December 2015.
• U.S. DSCSA in November 2017.
• The European Union’s Federated Medicines Directive in
This article will look to explain why pharmaceutical companies, CMOs, and CPOs should start talking now, and what
they need to achieve by these deadlines.
CHALLENGE IS TWOFOLD, STAKES ARE HIGH
Two primary tasks need to be accomplished in order for
pharmaceutical companies and contract partners to continue to successfully work together in a serialized world.
First, lines must be upgraded and second, data exchange
must be achieved.
Without the first, serialized product cannot be produced
and packaged. Without the second, required serial number
information cannot be passed between them or to downstream trade partners.
If CMOs and CPOs cannot produce serialized product and
exchange the data when the deadlines arrive, then they will
not be able to produce compliant - and saleable – product.
Pharmaceutical companies risk drug shortages with patient
impact, and contract manufacturers and packagers risk losing business to competitors who are better prepared.
Pharmaceutical companies have a lot of relationships to
navigate. Communicating specific serialization needs, deciding when upgrades should begin, and agreeing on financial
responsibility will take months. The upcoming Brazil, U.S.
and European requirements already impose tight preparatory timelines, so if you need to allow for a lot of communication back and forth, that’s all the more reason to start
early. In addition, if every pharmaceutical company begins
working with their contractors at the last minute, CMOs and
CPOs will be incapable of meeting everyone’s demands in
time. Not only will individual projects take many months to
complete, but contractors are balancing dozens of different
customers and each comes with not just diverse regulatory
requirements, but with different business and operational
LINE UPGRADES MUST BE PLANNED & EXECUTED
Right now, many pharmaceutical companies are focused
on upgrading their internal packaging lines and aren’t yet
Why Companies and Contract
Partners Must Work Together
Pharmaceutical companies risk drug shortages with patient impact, and con-
tract manufacturers and packagers risk losing business to competitors who are
n By Brian Daleiden