With drug counterfeiting on the rise and regulatory deadlines fast approaching, the pharmaceutical supply chain will soon be at a critical point as it strives to ensure patient safety. From drug manufacturers to distributors, all supply chain partners will need to make crucial decisions to upgrade their production lines to comply with the Drug Supply Chain Security Act (DSCSA), Falsified Medicines Directive (FMD) and emerging market traceability deadlines.
Evolving industry regulations for the implementation of industry serialisation present real and global challenges for both pharmaceutical and biotech companies, particularly in light of imminent compliance deadlines with the DSCSA in the United States, as well as European Union requirements and those of emerging markets such as China, South Korea, Brazil and others. Under intense pressure to meet these regulatory timings, some of the industry’s brightest minds shared their experience and best practices regarding implementing an effective serialisation strategy at a dedicated Serialisation Forum event in London, UK.
Hosting the event, leading pharmaceutical outsourcing services provider PCI Pharma Services collaborated with Antares, Crest Solutions and Multi-Packaging Solutions (MPS) to highlight the need for all manufacturers, distributors and supply chain partners to upgrade their production lines in compliance with the forthcoming traceability deadlines. Opening the session, Christoph Krähenbühl, Senior Director at leading European Serialisation consulting firm, 3C Integrity, gave his insights on preparing for the industry’s pending global serialisation requirements. 3C Integrity recently joined forces with leading US consulting firm Excellis Health.
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