Lonza announced that its integrated development and manufacturing site for biopharmaceutical liquid-filled hard capsules in Edinburgh (UK) has new anti-counterfeiting security capabilities in place and is in full compliance with EU and U.S. regulatory requirements for serialization.
Basel/Switzerland — With increasing threats to patient safety from counterfeited and diverted pharmaceuticals, regulatory mandates for serialization in more than 40 countries are being implemented to secure the world’s pharmaceutical supply chain. Serialization — also known as track-and-trace — refers to country- or region-specific systems used to track the passage of pharmaceuticals through the supply chain and into the marketplace.
According to the World Health Organization, an estimated 7-15 % of all medicines sold in developed countries are falsified — either contaminated or containing the wrong active or the right active in the wrong dose — and up to 40 % of medicines in developing countries are counterfeit.
The EU Falsified Medicines Directive (FMD) Safety Features Delegated Regulation dictates that all licensed drug products must be serialized from early 2019. Similarly, serialization will be officially required in the United States from November 2018 in line with the U.S. Drug Supply Chain Security Act (DSCSA).
“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. The new serialization line and quality system — fully commissioned and qualified this year — are now being used to serialize the customers’ sales packs, in advance of the serialization deadlines.
The requirements of serialization and product tracking (SPT) mandates vary by country or legislative region. However, every region is implementing compliance reporting systems that oblige pharmaceutical companies to provide the regulators a mix of master data, packaging and serialization information or supply chain transaction events, among others.
The implementation of these anti-counterfeit technologies is the most extensive preventive measure used by government authorities to help guarantee a secure supply chain worldwide.
The company’s new serialization line will serialize and tamper-proof liquid-filled hard-capsule (LFHC) sales packs (cartons) and will aggregate cartons to shippers and shippers to pallets. The system utilizes Optel Group technology and has been designed to meet the varied requirements across all key countries and regions. The system also serves to complement the site’s capabilities in supplying commercial market-ready packaging (blisters, leaflets, cartons, shippers) for its customers.
Specifically, five new processes are in place to combat counterfeiting schemes and protect the security of supply of LFHC products: Sales Pack (Carton) Printing and Inspection, Shipper to pallet aggregation, Post Batch Rework, Receiving Serialization Codes, Data Storage and Communications.