Allison Gilpin, business unit manager, global serialisation and Ray Hook, manager global serialisation services, PCI Pharma Services, discuss the impact of serialisation requirements on packaging operations.
Crunch time
Deadlines for including unique product identifiers on prescription drugs are putting a strain on multiple parts of the industry, much of which is ill-prepared to meet the targets. Recognising this lack of readiness, the FDA has now extended its deadline for the US Drug Supply Chain Security Act (DSCSA) for another year to November 2018. European regulations will come in two years. Companies cannot afford to wait to adapt their supply chains to ease the complicated and challenging transition to serialisation. There is value in seeking support from suppliers which have taken a long-term, strategic approach to DSCSA requirements.