Pharmaceutical labeling: Data, data everywhere
by Laura Johnson, on March 24, 2016
The 4th Annual Pharmaceutical Labeling Compliance event, held last week in Boston, brought together nearly 100 professionals involved in the packaging and labeling in pharmaceuticals. Many of the sessions focused on the execution of the Company Core Data Sheet (CCDS), which serves as the primary reference document used to create a drug’s package, label, patient literature, etc.
Everything related to a drug’s safety and efficacy goes into the CCDS, including the requisite FDA and EU compliance information.As evidenced by so many discussions (and questions!) on the topic, creating and maintaining the CCDS is a real challenge. And one of the biggest reasons is the dependency on multiple data sources within organizations. There is simply no silver bullet to harmonize data from the disparate databases housing critical safety, regulatory, packaging, and country-specific information. Also, because there are different departments involved in managing this data—and large companies by their very nature tend to operate in silos—it’s a struggle to find a standard process that keeps everyone informed when changes or updates are made.
Throw in ongoing mergers and acquisitions, where some pharma manufacturers need to seamlessly integrate a whole new set of data, and it’s easy to see why events like this are needed. The end goal is to land on a faster, easier, end-to-end process to optimize pharmaceutical labels. But judging by what we heard from attendees, most companies just aren’t there yet and still need answers.
What’s ironic is that the very same outcomes desired by companies with their CCDS—tighter data integration, easier changes and updates, faster compliance with global regulatory and customer requirements—can be achieved with barcode label software at the supply chain level. It’s an often overlooked part of the process, yet many pharma companies are harnessing data and advancements in enterprise labeling software to save millions of dollars on warehousing, transportation, and distribution.
We invite you to uncover the value of enterprise labeling software and how it can help optimize your supply chain operations. Download this customer webinar with Ferring Pharmaceutical to find out more about pharmaceutical labeling.