Systech, a global technology provider of digital product authentication, has successfully upgraded serialization lines for Takeda to meet new Russian serialization regulations. The first deadline for the pharma labeling system (cryptographic serialization and tracing system) of the Russian Federation was October 1, 2019, requiring packages of drugs targeting high-cost nosology group 7 products to be serialized according to these Russia-specific technical guidelines. In accordance with the new Russian regulations, some of Takeda’s serialization lines had to comply by the October 1 deadline.

The new medicinal products labeling requirements stipulating the use of cryptographic coding dramatically changed the technical requirements for the printing of identifiers and configuration of Takeda’s serialization information system. These changes also required a review of all packaging line vision and printing equipment to ensure they could print and verify barcodes with the new crypto code data matrix. This was achieved within a relatively short period of time due to Takeda’s strong focus on printer and vision equipment standardization.  

Takeda worked closely with Systech to upgrade its serialization lines in order to meet the October 1 deadline. Takeda has a total of 25 Systech serialization lines in five countries that are impacted by this new regulation.

“This was an aggressive schedule for Systech to meet and we started working with Takeda early in 2019 to assess needs for each line,” said David DeJean, senior vice president of product management and strategy at Systech. “We hit many speed bumps along the way, but Takeda is now a clear frontrunner in producing the first commercial crypto code batches and having them reported throughout the complete supply chain to the Russian governmental database (CRPT).”

“It’s a testament to Systech’s global reach and serialization expertise to get such a large number of globally dispersed serialization lines upgraded and in production within this period of time,” said Michael Ritter, serialization and digital enabling lead at Takeda.