A SIMPLE STANDARD THAT'S MUCH MORE COMPLEX

Last year, the FDA made the long-awaited recommendation in its guidance that all pharmaceutical trading partners adopt GS1's Electronic Product Code Information Services (EPCIS) as the new format for data exchange, and "make a collaborative effort" to follow the standard. The guidance cited EPCIS' compatibility “with a range of technological approaches” and its existing broad acceptance by trading partners across the industry.

The guidance bolstered the pharma supply chain's transition to electronic information sharing, on top of fulfilling the design of DSCSA for a given pharmaceutical product (individually, not just at the lot level) to be transparently traceable through every point in its life cycle, from manufacture through end sale.

EPCIS IN 5 MINUTES

The easiest way to understand EPCIS is to regard it as a blunt, extremely literal, extremely detailed event history. Each element of a product's journey records information like where it is, who has it, and when it changed hands, in addition to details on what it is and how it's assembled, supporting accurate track-and-trace operations.

• Item identification: A unique identifier assigned to each product unit (serial number, GTIN, EPC)

• Event data: Information about the transaction, movement, or status of the product, such as transaction history, transaction information, and transaction statement. (Note: Transaction History is being phased out with the final serialization deadline of November 27, 2023.)

• Location and time data: Information about the location of the product, such as facility, warehouse, or retail, and when it was received, shipped, or transferred between sites.

• Business data: Information about the transaction associated with the product, including the parties involved, quantity of product, and terms of the transaction.

• Aggregation: Details on how the product has been aggregated to a case or pallet.

AN EPIC EPCIS INCREASE

EPCIS files record any number of events at a high level of detail. Having a solution in place is vital; while it's technically possible to read an EPCIS file with your own eyes, getting the information you need for any given part of a product's history means manually scrolling through dozens or hundreds of pages of code. That means any given review can take hours, when a solution will simply give you the same information up front.

But EPCIS files aren't just large and complex: they're also increasing massively in volume.

Earlier this year, LSPedia found that total EPCIS exchange volume in the Test Environment (where manufacturers test EPCIS exchange with wholesale customers) was increasing many times over month to month, as item-level traceability created new files for each individual saleable unit. Overall transaction file exchanges in the pharmaceutical industry are on their way to a hundredfold increase over the next year.

In short, more and more upstream trading partners are getting on track, and they're expecting trading partners to follow suit so they can all comply and get the benefits of greater traceability.

With such heavy increases in data complexity and exchange volume, the industry is bracing for a commensurate increase in the transaction data errors known as exceptions. Every business in the pharma supply chain will need to be ready for these, and they can be unpredictable, particularly as myriad businesses make their switch to EPCIS. Without preparation, any pharma trading partner is vulnerable to problems that can be difficult and time-consuming to solve -- all while product is quarantined.

This is why it's vital to take the stabilization period seriously, and use the time to polish and test your systems! If you still have questions on how to get started, contact us today or write to dscsa@lspedia.com.