Despite FDA extension of the serialization deadline for manufacturers, CDMO UPM continues with early implementation.
One in ten medicines worldwide are counterfeit, according to the Pharmaceutical Research and Manufacturer’s Association, the World Customs Organization estimates that drug counterfeiting is a $200 billion business.
Countries around the world have responded by introducing serialization trace regulations that require the tracking and tracing of drug products as they move through the supply chain. In the US, the Drug Supply Chain Security Act (DSCSA) is the relevant legislation, and it applies to manufacturers, packagers, distributors and others involved in the production and delivery of drugs to patients. Requirements are being phased in over several years, but those companies that proactively develop serialization solutions will have a competitive advantage.
Serialization can be particularly challenging for contract manufacturers that produce many different products for many different clients. November was the deadline established by the DSCSA for manufacturers, but in June 2017, FDA extended the date to November 2018 due to the lack of readiness of both branded pharmaceutical companies and contract manufacturers, as well as the limited number of vendors able to provide serialization solutions.
Contract development and manufacturing organization, UPM Pharmaceuticals, successfully serialized its first product in May 2017 and expects to have all client products serialized by— if not before—the extended deadline of November 2017.
As its serialization hardware platform, UPM used development and production inspection solutions from Lateus, a German company with over 40 years of experience in the field. Members of UPM’s serialization team attended Laetus’ ‘Track and Trace Academy’ to obtain training and hands-on practice. TraceLink, a Track-and-Trace Network for connecting the pharmaceutical supply chain worldwide, was selected as UPM’s code provider.
CEO of UPM Pharmaceuticals, Jim Gregory commented on the achievement, saying: “While we know the FDA recently granted a one year extension on their serialization deadline, we are very excited about our early implementation and success with serialization. Using the Lateus system provides 100% verification of the data matrix code against the human readable text. This insures products leaving the UPM facility are fully compliant and traceable. Lateus equipment also allowed us flexibility in that everything is printed in our label office and can be printed in advance. This saves time and the client money,” he added.