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Serialization and related track and trace regulations are now a strategic requirement. Propelled by a growing counterfeit drug threat that kills more than 100,000 people annually, regulations for drug serialization, supply chain traceability, and government reporting will affect almost 80 percent of the world’s drug supply by the end of 2018.
In the U.S., per the 2013 DSCSA, lot-level traceability, product and transaction verification, and unit-level serialization will be instituted in phases starting in 2015, and will converge into end-to-end unit-level traceability in 2023. The 2017 DSCSA serialization deadlines will mark the first time that many pharmaceutical companies and their supply chain partners will have to implement serialization and manage serialized product inventory.
Implementation of the forty pages of complex DSCSA regulations can be broken down into three general phases:
• 2015: Lot-level traceability and verification of products and transactions
• 2017-2020: Serialization of drug products and enhanced verification of serialized product identity
• 2023: Unit-level traceability
To understand the full complexity of serialization readiness, here are five key issues that pharmaceutical companies need to consider as they build their serialization programs and ask themselves, “When do I need to start?”
1. Serialization is More than Putting a Number on a Bottle
Current and proposed serialization and barcoding regulations create a complex, strategic data management challenge. While U.S. DSCSA data requirements are fairly straightforward, globally there is a highly diverse serialization ecosystem.
2. Serialization Forces Supply and Trade Partner Networks to Evolve
The serialization infrastructure you develop will have to support a surprising diversity of data types, connection methods, business preferences and regulatory interpretations across your various network relationships.
3. Serialization Creates Unprecedented Scalability Challenges
The data generated and the transaction events created are orders of magnitude beyond what companies in the pharma supply chain are used to.
4. Serialization Fundamentally Changes How Your Company Conducts Business
It’s crucial to reach out across the organization, from quality and artwork, to supply planning, trade relations and commercial operations, to understand how corporate functions are impacted by serialization.
5. Serialization Preparation Timelines are Always Longer than They Appear
Serializing packaging lines and serialization enabling a packaging site is long and complicated project which may take from 12-18 months to complete from hardware acquisition to live site validation. But the true serialization readiness timeline must incorporate many other factors.
The approach to serialization must be staged. Starting early also lets you uncover issues and mitigate risks before full-scale serialization and network implementation.