Category: Regulatory

European GDP Inspections: Preperation And Expectations


Ken Maltas – Director of R & D                                                                               Ian Buck –  Director of Sales & Marketing – ThermoSafe Europe


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.

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New Cold Chain Solutions Meet Regulatory, Shipper Requirements

“Upholding cold-chain integrity and regulatory compliance standards are morphing into major issues, experts say, with the explosion of temperature-sensitive pharmaceutical products, new global and regional manufacturing mandates, and supply chains extending worldwide. These are among the primary drivers affecting the development of specialized shipping boxes and containers used for transporting these drugs to market.”

Click here to read the full article on Pharmaceutical Commerce.

Industry Stimuli Article Proposes Expanding USP Definition of Controlled Room Temperature

A stimuli article authored by Desmond Hunt, Ph.D., Senior Scientific Liaison at USP, and several members of the pharmaceutical industry has been initiated with the objective to solicit public comment and stimulate discussion regarding a potential revision—as yet unproposed in PF—of USP’s definition for Controlled Room Temperature. The proposal advances the view to expand the current definition of Controlled Room Temperature (CRT) from +20°C to +25°C to +2°C to +30°C. Continue reading