JUSTIN SCHROEDER
Executive/Director, Global Marketing & Design at PCI Pharma Services, USA

Abstract

As a global leader in pharmaceutical packaging, PCI Pharma Services references over six years of serializing commercial drug product destined to both domestic and emerging markets in identifying lessons learned from identifying initial Serialization and Aggregation strategy to ultimate execution: spanning the lifecycle of initial planning, installation, readiness, and finally full scale implementation. Companies can avoid many pitfalls and delays with a carefully crafted strategy for both Serialization regulatory compliance as well as more broadly identified anticounterfeiting strategies.

While many leading pharmaceutical companies have actively progressed their Serialization initiatives, the large proportion dragged their heels in a wait-and-see approach to enforcement, leaving them in a precarious position. Equipment suppliers, third party EPCIS providers, consultants and CMOs raised concern over the skyrocketing demand on resources as the industry collectively eyed the impending deadline.  This has led to a one-year delay in enforcement by the FDA.

A UNIQUE PERSPECTIVE

PCI is commonly asked to mimic its internal Serialization systems for the medicines we package, and we are afforded considerable insight into the process of Serialization implementation.

The industry has been given a reprieve, although an additional 12 months is not a lot of time, frankly. The industry continues to lag considerably, in the States as well as for the EU FMD requirements.  The slow adoption has left the industry challenged for increasingly scarce resources, also very true for CMO’s.

HOW COMMITTED?

We engage new clients almost daily on the subject of Serialization implementation. One of t ...