GMPs Creep into GDPs
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.”