Track and Trace Solutions for Pharmaceuticals
Pharmaceutical Track and trace allow you to pinpoint any item's present and previous locations across your supply chain. It's a strong instrument that no pharma company can afford to ignore, especially now that rules demand to track and trace capabilities as well as specific obligations for documenting and sharing supply chain data.
We've been conducting pharmaceutical track and trace for nearly 20 years, longer than any other solution provider, and we thought it was important to review the basics as part of our ongoing conversation about the pharma supply chain. Let us explore.
Perks of Track and Trace Solutions for Pharmaceuticals
A track and trace system for pharmaceuticals, when designed and implemented correctly, does exactly what its name implies: it tracks a drug, a vaccine, a medical device — anything in any configuration — as it moves forward through the supply chain and traces backwards to reveal where it has been in the supply chain, all the way back to the individual ingredients or components that combined to create it.
You can track every item in your supply chain with tracking. Its many advantages include improving operational efficiency and speed, preventing counterfeit, adulterated, or expired medications from entering the supply chain, preventing theft and diversion, ensuring product safety and environmental stability, and preventing counterfeit, adulterated, or expired medications from entering the supply chain.
You can track everything in your supply chain with traceability. It has a number of advantages, including quick and easy product returns, current recall management capabilities, brand protection, and consumer confidence.
Serialization for Pharma Track and Trace
Pharmaceutical Track and trace is based on a thoughtful combination of technologies and practices. Its "building block" is serialization, which gives a product a unique identity that allows it to be tracked and traced around the clock, authenticated at any time (for example, prior to sale, during dispensing, during return, or during a recall), and turned into a "digital asset" with a variety of benefits and applications.
Other procedures and data points derived from track and trace must be supported by serialized products. Those additional data points are provided by so-called "T3" data for the Drug Supply Chain Security Act (DSCSA) in the United States (transaction history, transaction statement, transaction information).
These data points are compiled in a master database called the European HUB (EU HUB) as well as country-specific databases called the National Medicines Verification System in Europe (NMVS). It is the National Track and Trace Digital System in Russia (Chestny ZNAK).
Are track and trace regulations as common as serialization requirements?
Not every jurisdiction that requires serialization also requires track and trace; nevertheless, regulators in many countries are beginning to combine the two to meet their aims, which include preventing counterfeit, stolen, or contaminated medications.
The US DSCSA, for example, now specifies that manufacturers must begin the track and trace process by producing T3 data for pharmaceuticals at the lot level. Every stakeholder in the supply chain must receive an electronic copy of the T3 data, from wholesalers through repackages and dispensers. If they sell the product, they must also produce and update the T3 data.
Recalled or returned pharmaceuticals will be easily tracked back through the supply chain once the DSCSA rules are fully implemented in November 2023. This will be performed by switching track and trace from lot-level to unit-level (i.e., serialized).
Pharmaceutical Track and trace is no longer a possibility. It is a prerequisite for enterprises wishing to do business in the United States, Europe, Russia, Brazil, and nearly every other market on the planet. Simply put, not having a contemporary track and trace system is a risk that should not be taken.