By:
Ken Maltas – Director of R & D Ian Buck – Director of Sales & Marketing – ThermoSafe Europe
Overview
On 7th March 2013, the new EU GDP guidelines were finally released ending much speculation and uncertainty. The six month grace period passed as quickly as expected and since 8th September 2013 the EU GDP have been in full force with regular inspections now occurring both internally and from regulatory authorities.
The updates were heralded as an unprecedented change for the biopharmaceutical industry and all those involved in their supply chain networks. The main changes came in the shape of the requirements for temperature controlled distribution apply not only to cold chain (+2°C to +8°C) but also to room temperature/ambient products. Secondly, the guidelines have increased emphasis on risk based approaches.