Tracing Pharma: The Johnson & Johnson Approach


Tracing Pharma: The Johnson & Johnson Approach

The Johnson & Johnson Supply Chain (JJSC) organization has established a dedicated team, focused on meeting the milestones set by the health authorities around the world and has created a comprehensive global program for end-to-end serialization from development to point of dispense.


Packaging Today spoke with Mike Rose, Vice President, supply chain visibility, Johnson & Johnson Supply Chain



How disruptive has the move to universal serialization been across the pharma industry? 


While serialization is a major undertaking; starting early, collaboration and industry standards allow for no disruption to our patients and minimal disruption during implementation. As mandates were finalized, the JJSC organization established a dedicated team and created a comprehensive global program for end-to-end (development to point of dispense) serialization.

The team focuses on meeting the numerous milestones set by the health authorities around the world. An enterprise serialization infrastructure was built and deployed and we’ve collaborated with our customers to test solutions in real-world pilots. Through serialization and the need to get track & trace working right with no disruption, there is much more collaboration occurring between trading partners than ever before.



Is the supply chain integrated enough to ensure serialization works to combat counterfeiting?


Supply chains need to create end-to-end capabilities for track & trace to be able to effectively combat counterfeiting. Those capabilities do not exist yet as track & trace is not a requirement in all countries. While the European Union (EU) does not mandate track & trace, the Falsified Medicines Directive (FMD) goes a step further requiring an end-to-end verification model where the dispenser must verify the integrity of the tamper evident feature as well as scan and verify the serial number applied by the manufacturer.  The manufacturer is required by the FMD Delegated Act to pay for the cost of the verification system across the EU and within each Member State.




What does the future of serialization look like?


The Johnson & Johnson Family of Companies is focused on ensuring the integrity and safety of our supply chain. We embrace product identification and traceability because of its benefits to our patients, customers, and the industry.

Health Authorities from more than 45 countries around the world have issued rules requiring pharmaceutical manufacturers to uniquely identify their products with a global identifier and a serial number. Although the specifics of each countries’ regulation may differ, the purpose is to enhance the safety of the pharmaceutical supply chain visibility, make identification of pharmaceutical products easier, thereby helping to protect patient safety.

JJSC has taken a leadership role in driving forward standards implementation in several areas of healthcare—pharmaceuticals, retail healthcare supply chain, medical devices.