 Track and trace has been positioned as an elemental cornerstone of supply chain security in the pharmaceutical and medical device industry for years.
Governments around the world are moving toward product serialization as a key component of regulations to protect the integrity and safely of healthcare logistics and the supply chain for drugs and medical devices. Recently, initiatives in Brazil, Turkey and China have refocused industry attention on Track and Trace solutions in trade journals. And the freshly ratified European Union’s “Falsified Medicine Directive” sets the stage for expanded use of serialization within the EU.
While the 2008 decision to delay California’s requirements lessens the immediate need in the US to embrace serialized ePedigree solutions, the revised 2015 deadline is not that far away. So, it would appear that the need to provide full Track and Trace at the sellable unit level across the supply chain is an inevitability that the pharmaceutical industry must be prepared to embrace.
Yet several relevant surveys indicate that the industry focus on Track and Trace has actually diminished somewhat over recent years. This can be partially attributed to additional breathing room provided by California’s decision to push back serialized ePedigree initial deadline from 2011 to 2015. But ongoing initiatives in other countries should still be heightening overall industry movement towards this initiative.
Cost factors certainly remain a retardant in the expansion of Track and Trace in the industry. Faced with evolving country and state-specific regulatory requirements, it is natural for manufacturers and distributions to approach the topic from the perspective of only meeting the requirement on-hand.
 Compliance can also obscure the extended value of Track and Trace in securing the pharmaceutical supply chain. It also tends to focus the attention on downstream tracking of finished product within a specific country. Given that the majority of active ingredients are sourced from China, India and other emerging countries, Track and Trace in this format only partially address the security challenges faced by the industry.
Globalization poses enormous security challenges to the supply chains – especially when pharmaceutical and medical products are involved. Counterfeiting, grey market and contamination are not problems that are restricted to branded drugs or developed countries. Government bodies and manufacturers are becoming increasingly aware of the global security challenges and the fact that adherence to GMP/GDP cannot stop at the border.
In response, Taggant and other authentication technologies will continue to evolve. However, the visibility and authentication services provided by Track and Trace still remain a key component to the supply chain security equation.
In the meantime, manufacturers should put Track and Trace back into focus rather than wait until they are compelled to meet specific regulatory requirements. The best path forward is to initiate a full assessment of overall supply chain security needs, followed by a strategic plan on how best to pursue Track and Trace both upstream and downstream within the supply chain.
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