"This new guid eline is long overdue," says Dr. Ruediger Lomb, Global Director of Quality and Technical Compliance for World Courier Group.
"The globalization of the industry over the past two decades has increased risk exponentially for pharmaceutical companies, medical professionals and patients. The tendency to outsource production to locations around the world has led to quantum changes in storage and transportation requirements, in the number of parties now involved in the supply chain, in thecompetency and qualific ation of these suppliers, and in the oversight required.’
‘Factor into this the stringent temperature requirements of many of today’s biological products and the spike in counterfeit drugs and we can readily see the importance of introducing regulatory chang e that better reflects our current distribution realities."
According to Dr. Lomb, the vague generalities associated with the earlier directive have been replaced with concrete regulations in 2013.
"The prevalent themes of responsibility, quality manageme nt and process control will go a long way towards actualizing the EU’s objective of improving product quality and safety," he says