European Institute for Pharma Logistics GmbH

Qualifizierungs- und Auditierungs-Lösungen für die Pharma-Logistik

PRESS RELEASE

 

Stuttgart, 3rd February 2014

 

GDP Amendment: The Pharma Logistics Institute EIPL takes stock for the first time

 

The EU directive on Good Distribution Practice (GDP) has been in force since 2013. It applies the known principles of the Good Manufacturing Practices from pharmaceutical manufacturing to the transport of medication to a greater degree. The EIPL (European Institute for Pharma Logistics) advises manufacturers and transport contractors on implementing the GDP and is now taking stock of its success for the first time. The result has been essentially positive even though the pharmaceutical logistics experts in Stuttgart still see a great need for action. “The market recognised that the improvements initiated by the GDP amendment are necessary for transport quality,” says the Managing Director of EIPL, Dr Thomas Beckert. “It is obvious that the temperature-controlled transportation of pharmaceuticals is increasingly developing into a standard. However, the knowledge of smaller non-specialist forwarders, in particular, could still be improved. This is where we bring in our range of training courses and our vehicle qualification service.” Pressure to improve logistics processes is not only coming from the lawmakers, but also from the pharmaceutical manufacturers themselves. “With our quality agreements, which overlie the EU GDP standard and were initiated in 2005 with the revision of the WHO GDPs made at that time, we define the minimum requirements,” says Jochen Heinzel, Global Quality Manager at Roche. Strict requirements have also existed at Boehringer Ingelheim for years: “The ambitious in-house guidelines guarantee the stringent implementation of the worldwide GDP requirements such as the WHO and the EU GDP,” explains Heike Gottschalg, responsible for Global Process and Computer System Validation Compliance. “We regularly audit the quality management system and the process documentation of our logistics contractors. As a globally active manufacturer, the amendment to the EU GDP is something we very much welcome since it puts the focus on ensuring the quality of the products during their transportation.”

 

 

The GDP amendment superseded the 1994 European regulations for the transport of medication. The long awaited amendment to the EU GDP from 7th March 2013 (with a 6 month long transition period) was revised for the first time in late autumn 2013. The current version has been valid since 24th November 2013 and completely replaced the version from 7th March 2013. 

 

What have been the effects of the “activation” of the GDP amendment in its first months and how have those involved in the market assessed this development? Dr Thomas Beckert, Managing Director of the EIPL Institute, is cautiously optimistic: “Awareness is slowly being raised and a lot of companies are ready to assimilate the changes. In the meantime, most players have recognised the need for action in relation to the required transport quality due to the cost-risk considerations.” At the same time, there are still a lot of open questions above all with regard to the qualification of vehicles according to the GDP amendment. “This is a new topic and, as a result, pharmaceutical manufacturers and forwarders have a lot that they need to do. We offer support here with our services from the design and installation qualification through to the operational and performance qualification.”

Training and sensitisation in focus

Another central theme is the training of employees and the logistics contractors involved according to the GDP directive and its importance is underlined by the EIPL and pharmaceutical companies such as Roche and Boehringer in unison. “With our standardised training programme, we are not only giving drivers and warehouse staff the necessary munition, but also yard managers, QM representatives and managing directors,” says Dr Thomas Beckert. “In addition, we are helping with the development of documentation processes and carrying out audits when required. This ensures a high degree of safety.” Companies like Boehringer Ingelheim make use of the pharmaceutical logistics experts´ offer to deliver targeted further training for their employees. “Due to the increase in transports of temperature-sensitive products, the demands made in terms of quality control are constantly intensifying,” says Heike Gottschalg from the Ingelheim pharmaceutical company. “That´s why we organised training in the changes to the EU GDP for our quality management team early on.”

 

Roche organises training courses for its logistics partners itself, but it is not ruling out support from external consulting companies such as EIPL in the medium term as the demands on Swiss companies are continuing to increase. “Using our internal pharmaceutical quality system, we are clearly formulating our expectations of the logistics contractors,” stresses Jochen Heinzel. “On the other hand, we support our partners, for example through a modular training course specifically for the staff of logistics contractors because one thing is clear: the better informed our contractors are, the more responsibility they can take on and the better the implementation of the GDP will work.” It´s important that the quality manager has a comprehensive view of the whole supply chain down to the ´last miles´ because the process chain is only as strong as its weakest link.” Here too, Heike Gottschalg from Boehringer Ingelheim also speaks out in favour of the consistent implementation of GDP: “We are working with the guidelines very proactively and expect the same from our contractors.”

 

 

Photos:

 

  Qualified trailer for pharmaceutical transport (Picture source: EIPL GmbH)

 

 

 Temperature mapping fort he purposes of the qualification is carried out with special data Loggers

  (Picture source: EIPL GmbH)

 

 Temperature-controlled warehouse for Roche pharmaceutical products

 (Picture source: F. Hoffmann-La Roche Ltd.)

 

  

Further information:

EIPL European Institute for Pharma Logistics GmbH

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 - 70825 Stuttgart / Korntal Muenchingen
 

Tel: +49 (0)7150-35179-250


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EIPL European Institute for Pharma Logistics GmbH

The EIPL European Institute for Pharma Logistics GmbH, founded in 2012 and based in Korntal-Muenchingen near to Stuttgart, specialises in knowledge transer and services on the interface between pharmaceuticals and logistics. The team, which brings together members from different disciplines, set out with the objective of liaising between the pharmaceutical and logistics industries as an independent entity with an advisory role. As a so-called “qualified person” (QP), the head of the institute and its Managing Director, Dr Thomas Beckert, supports companies in the obtaining of qualifications for vehicles and staff training courses together with his EIPL team. The Institute also prepares expert assessments, carries out audits and, when required, creates quality control systems for pharmaceutical transport companies.