Understanding The Challenges And Benefits Of Just-In-Time Labeling

By Leah Tufts, General Manager, PCI Clinical Trial Services, Cincinnati

Like all clinical supply chain initiatives, just-in-time labeling (JIT) comes with its benefits, but also has its challenges. This article will help you understand and overcome the challenges of just-in-time labeling so you can maximize its benefits.

With just-in-time labeling, rather than labeling drug product in large batches, sponsors are able to request labeling of drug for specific countries, clinical sites, patients or any combination there within. This can happen for many reasons:

• to reduce the waste of expensive drug products
• to more efficiently use and distribute expensive drug products
• to decrease the potential need of a second manufacturing run of drug products
• to accommodate new countries, sites, and patients
• to maximize use of drug product with short expiration dates or limited stability data
• other scenarios where traditional labeling is not feasible or economical

Despite its benefits, JIT labeling does come with a few obstacles that need to be considered. First, because of the shortened time frame to execute labeling, costs per labeling operation can be higher. The same GMP requirements for traceability are required even in a JIT scenario – so, while the timelines are shortened, the requirements for documentation and execution remain the same. Additionally, from the sponsor’s perspective, managing the supply chain can be more work and time intensive due to allocated supply not being forecasted, but managed in a JIT manner.