Track & Trace

One barrier to implementing product serialisation has been the variation and uncertainty of what would be required in the various regions around the world. Susan Birks talked to key players about how ready the industry is to meet the deadlines

The US Food and Drug Administration (FDA) announced in February that counterfeit vials of Roche/Genentech’s cancer drug Avastin were sold to a number of medical practices across the country. While the exact sources of the phony drug remain a mystery, authorities traced the fake batch through several distributors throughout Canada, the UK, Denmark and Switzerland to only end up with an unlicensed supplier in the Middle East as the possible culprit.

When it comes to serialization, "it’s never as easy as it sounds,” Unither Pharmaceutical’s Corporate Serialization Project Manager, Silvère Duchemin told the Pharmapack Europe crowd.
And, from his company’s perspective as a CMO with four plants in France and one in the U.S., he should know.

With 130 clients, more than 1,000 products distributed to 85 countries, Unither has serialized more than 40 million boxes, and have launched successfull serialization lines for China in 2012, Turkey in 2013, and Korea in 2014.

Container ship movement in August 2011, as recorded by the Satellite Automatic Identification System (S-AIS). The velocity of the dots in the video reflects ship speed. The onboard S-AIS transponder electronically transmitted ship information, location, and speed to satellite, which monitors and tracks ship locations for safety purposes.

The U.S. has been rated as “Average” in its food traceability regulations and practices, listed as “trailing most other countries” and falling well below the “Superior” rating of the countries of the European Union. Although the 2014 report from the Global Food Traceability Center (GFTC), which rated 21 countries, acknowledged the expectation that FSMA will improve U.S. food traceability capabilities, it added as well that this development is still in its early stages.

The Track and Trace testbed brings the Industrial Internet onto the factory floor. The goal is to manage handheld power tools in manufacturing and maintenance environments. This "management" involves efficiently tracking and tracing the usage of these tools to ensure their proper use, prevent their misuse and collect data on their usage and status.

India's health ministry reportedly is drafting a requirement that pharmaceuticals carry barcodes at the primary level of packaging, the single vials and strips of drugs. Current regulations require them on secondary and tertiary packaging only.
The Times of India cited an unnamed official who said the intent was to enable a patient to "track and trace" a drug's provenance via a mobile device. The barcode information would be carried on a central website, the official said.

Adents, the increasingly visible French software provider and their unique Adents Pharma Suite solution, are revolutionizing the thinking about existing and pending global traceability and serialization regulations with their top-down corporate IT approach and emphasis on the importance of data exchange.

Parcel delivery services and web stores are presenting new mobile apps for the ultimate customer experience. Their apps keep us informed of where orders are, minute by minute. But to be able to provide customers with a valuable service, these apps should be needing further information from our side.

A reminder to pharma manufacturers, the Drug Supply Chain Security Act (DSCSA) deadlines are quickly approaching. Have you planned for the implementation of Transaction Documents for your packaged products and how to introduce them into your supply chain? Have you developed a strategy for implementing packaging serialized data and infrastructure?

Today’s consumers not only demand access to the goods and services they seek—they have the mobile devices with which to stay connected to their purchases throughout the entire order fulfillment process. They expect to be informed every step of the way and have the ability to change delivery options. That means they’re not just an end point in the supply chain; now, they’re part of it.

Libbs, a Brazilian pharmaceutical company, has used Atlantic Zeizer’s Medtracker software in a pilot project that ensures complete traceability of pharmaceuticals across the whole logistics chain compliant to the country’s legislation for the first time.

TraceLink Inc., the leader in protecting patient safety and enabling health for global Life Sciences, today announced record fourth quarter and full-year growth for 2014. As US pharmaceutical manufacturers and distributors worked to meet track and trace compliance requirements under the Drug Supply Chain Security Act (DSCSA), which became law on January 1, 2015, TraceLink experienced widespread customer adoption of its Life Sciences Cloud platform.

At a recent event, the Head of Product Security at Merck Serono shares his professional knowledge and insights into Serialization, Track and Trace, and e-Pedigree within the pharmaceutical supply chain.