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Recent revisions to the European Union’s good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.
Recent revisions to the European Union’s (EU) good distribution practices (GDPs), which were updated in 2013, reflect increased regulatory focus on the supply chain and how drugs get to the patient and point of dispensing, notes Dan Bell, Marken’s vice-president, Regulatory Compliance and Technical Affairs.
The revisions have also emphasized the importance of current good manufacturing practices (cGMPs), something that is clearly seen in Annex 15, Chapter 6 of the EU GDPs, which includes a section on risk assessment and planning, Bell says. As a result, suppliers have been investing more in equipment and in training. “Uncontrolled ambient product temperatures have become more important,” notes Bell. “We always knew that an item at 2 to 8 had to be kept there. Now we have 15 to 25, -20, -25, and -150 to consider. In addition, most guidelines are not very prescriptive. People have been left to figure things out for themselves.”
“Bits of GMP are creeping into the GDP world. If you were a drug manufacturer, you’ve already been doing this for 40 years, but it is a new experience for airlines and trucking companies to map out cold rooms where they are going to condition phase-change and other materials to be kept at fixed temperature,” he says.
Another important change with the EU GDP update was assigning responsibility to all parties in the cold chain, notes Paul Daniel, senior regulatory compliance expert and validation program manager at Vaisala. “Links in the distribution chain farther from the manufacturer are now under regulatory scrutiny. As a result, all distribution entities must now adopt standard GMP practices for temperature-controlled distribution,” he says.
Vol. 40, No. 8
When referring to this article, please cite as A. Shanley, "GMPs Creep into GDPs," sidebar to, "Manufacturing and Distribution Boundaries Blur," Pharmaceutical Technology 40 (8) 2016.