Article | May 10, 2017

Pharmaceutical Serialization: Is Your Data Management System Ready?

Source: Ropack Pharma Solutions

By Nicolas Girard, Ropack Pharma Solutions and Graham Clark, TraceLink

With Serialization Mandate Looming, Is Your Data Management System Ready?

The next phase of the Drug Supply Chain Security Act (DSCSA) is approaching, and it is approaching quickly. This is an especially crucial year as manufacturers face the November deadline that requires packages to be marked with a product identifier, serial number, lot number, and expiration. From there, the remaining deadlines for other stakeholders in the life sciences supply chain are staggered throughout the remaining six years of the regulation’s 10-year plan. By 2023, the goal is to have achieved item-level traceability from end to end that will allow detection and/or tracking of suspicious or dangerous products in the pharma supply chain.