ePedigree & Serialization: A new Standard in Accountability

Between new global serialization mandates, patent cliffs and major company consolidation the pharmaceutical manufacturing space is in the midst of a major transition. Some would say this was bound to happen, as our ‘global (supply chain) village’ continues to become more of a close-knit community.

Logistics management is no longer regionally based, but handled on a national and even global scale. Due to the complexities innate to such large supply chains, there is a significant increase both in complexity and in potential liability to the brand owner.

For example, it is not uncommon for active ingredients to be manufactured in one region of the world, packaged in “bright stock” form in another and then finally packaged for distribution in a third. If at any point in time it becomes necessary to recall that product, it can negatively impact multiple regions both nationally and globally. In response, pharmaceutical manufacturers must jump into action and react as quickly as possible to solve these issues before they spiral out of control.

Enter ePedigree and serialization mandates. By 2015 pharmaceutical manufacturers will be accountable for being able to track and trace where any given drug is in real-time, while simultaneously being able to trace its entire history throughout the manufacturing process.

Each mandate is aimed at improving patient safety, product integrity and supply chain security. Additionally, these mandates will further aid pharmaceutical manufacturers to gain full control, visibility and access to every single item in their supply chain – both inside and outside their walls. RFID technology will further enable pharmaceutical companies to track products throughout the production line and then compile robust data in an organized and reliable manner.

The goal of the mandates is simple. By 2015, when an event occurs inside the pharmaceutical supply chain, companies will be able to (and must) address the issue quickly, offer a transparent account for where every affected product is and begin to remedy the situation in a matter of hours. In preparation for the 2015 initiative, many companies are beginning to collaborate in development and implementation of flexible solutions that minimize the burden of compliance by increasing supply chain visibility and assisting in global serialization.

If they don’t, they not only risk inquiries and fines from the government, they also risk damage to their brand – damage that in today’s social media world may be irreversible.

John DiPalo

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