regulatoryDomino Printing Sciences has stressed the importance of quality coding when addressing item-level serialization at a seminar focused on preparing pharmaceutical manufacturers for the EU Falsified Medicines Directive (FMD).

Coming into force at the beginning of 2019, the FMD is expected to have a whole-business impact from data management to distribution. Speaking in Warsaw, Poland, at the recent DMP Group organized event, EU Life Sciences sector manager Bart Vansteenkiste explained the significance of long-term code stability as part of a whole-business holistic approach to the FMD, ensuring packaging lines adhere to the new industry standards.

“Understanding the foundations to printing quality codes has become essential for pharmaceutical manufacturers now that they know what is expected from them when the FMD is enforced,” Vansteenkiste said. “This means having comprehensive knowledge of the best practices and processes when it comes to printing technology, substrate material, product handling, code content and decoding.”

Vansteenkiste explained: “Any system is only as good as its weakest part, and for manufacturers this is particularly true through all phases of the packaging lifecycle, from printing codes at point of manufacturing with the highest possible grading up to reliably checking codes at point of dispensation in the pharmacies.”

With medicines disappearing in the supply chain for up to 3 years or longer, the necessity for high quality and optimized inks that can withstand the test of time is indispensable. Domino’s coding has been key in assisting pharmaceutical manufacturers move from batch to item-level serialization.

“The substrate material can have an impact on the coding process, in particular knowing whether the material is inkjet or laser-friendly. The impact must be considered when choosing or changing the packaging material,” Vansteenkiste added. “It is crucial for manufacturers to fully understand their cartons and what any changes could mean. At Domino we use a number of techniques, such as mass spectrometry, to help customers make the right choice between a number of given samples.”

Summing up the seminar – which also included discussions led by GS1, Oxford University and demonstrations by Intrex – Vansteenkiste stressed the importance of taking a holistic approach to choosing the right coding solution to address item-level serialization as the deadline for compliance gets closer. To support manufacturers, Domino has also written a series of best practice documents to assist customers in deploying a cost-effective and robust solution. Customers can access the documents online or by emailing falsifiedmedicines@domino-uk.com.