Lonza’s integrated development and manufacturing site for biopharmaceutical liquid-filled hard capsules has new anti-counterfeiting security capabilities in place and is now in full compliance with EU and U.S. regulatory requirements for serialization. 

With increasing threats to patient safety from counterfeited and diverted pharmaceuticals, new rules for serialization in more than 40 countries are being implemented to secure the world’s pharmaceutical supply chain. According to the World Health Organization, an estimated 7-15 percent of all medicines sold in developed countries are either contaminated or contain the wrong active or the right active in the wrong dose, and up to 40 percent of medicines in developing countries are counterfeit.

“It’s important for our customers to know that our Lonza Edinburgh facility is ahead of the curve and already fully compliant with the new regulatory requirements in the United States and EU to combat anti-counterfeiting,” said Jane Fraser, PhD, site head at Lonza’s Edinburgh facility. “Our new serialization line and quality system – fully commissioned and qualified this year – are now being used to serialize our customers’ sales packs, well in advance of the serialization deadlines.”

The requirements of serialization and product tracking (SPT) mandates vary by country or legislative region.