SYS-CON MEDIA Authors: Scott Bampton, Greg Ness, Elizabeth White, Glenn Rossman, Pat Romanski

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The EU GDP Guidelines Are out and Implementation is Underway. Now what?

LONDON, January 7, 2014 /PRNewswire/ --

As of March 7th 2013, the European Commission finalised and published the long awaited new Good Distribution Practice (GDP) guidelines. The European Medicines Agency (EMEA) has since stepped up its commitment to monitoring and controlling who is complying and implementing the new requirements by increasing its inspection manpower.

Luxembourg has already prepared for the future with its new dedicated Pharma & Healthcare Centre within the existing infrastructure of Luxembourg's airport cargocentre. The new state-of-the-art infrastructure of 3,000 m2 offers two distinct temperature zones (818 m2 "cold": +2°c to +8°c and 1,600 m2 "ambient" +15°c to +25°c, as well as 70 temperature-controlled ULD positions: +2° to +25°C) with permanent temperature monitoring and fulfilling all requirements of the WHO, IATA and EU 2013 guidelines on GDP for the proper distribution of medicinal products for human use.

In a European first, Luxembourg's logistics operators involved in pharma & healthcare logistics activities have taken the initiative to make Luxembourg's airfreight gateway fully Good Distribution Practice (GDP) compliant, qualified and certified according to the latest World Health Organisation (WHO) and EU 2013 GDP guidelines. Alongside the numerous Luxembourg-based logistics service providers involved in this project, even a cargo airline and an airport handling agent have decided to go through this certification process. This paves the way for an unprecedented European pharmaceutical and healthcare logistics gateway in Europe.  

Francois Leclercq, Sr Manager, Global Logistics Operations of Baxter BioScience stressed the strategic importance of the GDP compliant LuxairCargo Healthcare & Pharma center:

"It’s been many years that several of our life-saving critical products are being imported and exported on regular basis through the LuxairCargo Healthcare & Pharma center, which has always demonstrated very high level of standards on quality in operations, compliance with GDP’s and efficient partnership with all parties involved in the cold chain transportation of our products. Luxembourg is definitively a key strategic airport for pharmaceuticals cargo shipments."

This January Luxemburg will co-host Pharma IQ's 13th Annual Cool Chain and Controlled Room Temperature Logistics European Summit.  Logistics and Supply Chain leaders from across the pharmaceutical industry will gather in Luxemburg to discuss the new standards and expectations of the EU GDP guidelines. Regulatory leaders including Felix Patzak, Institute Surveillance from the Austrian Agency for Health and Food Safety (AGES), Terry Madigan, GDP Inspector, Inspectorate, Enforcement and Standards Division from the MHRA and Riekert Bruinink, Group Chairman of the PIC/S GDP Working Group, Member of the EMEA GDP Drafting of the Dutch Healthcare Inspectorate will be answering your questions and sharing their knowledge, insights on GDP.

Find the full programme and event details and registration information at http://www.coolchaineurope.com/press, call +44(0)20-7036-1300 or email [email protected].  

Media contact: Stacey Cross, Divisional Marketing Director, Pharma IQ, +44(0)20-7368-4920, [email protected] or visit http://www.coolchaineurope.com/press

Press are invited to attend this important industry forum, if you would like a complimentary press pass please email Stacey Cross at [email protected]

SOURCE Cool Chain IQ

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