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On Thursday 7 March, 2013 the long-expected EU Good Distribution Practices (EU GDP) were published. These guidelines are important for both the pharmaceutical industry and the logistical and distribution companies. Distribution of medicinal products is an important activity in the integrated supply chain management.
The purpose of the EU Good Distribution Practices is to ensure control over the distribution chain to maintain the quality and integrity of the distributed medicinal products.
The new EU GDP have the same structure and are aligned with the GMP regulation describing requirements for:
Premises and equipment
Complaints, returns, suspected falsified products and recalls
Documented risk assessment, mitigation and management is the basis for the distribution processes
Compared to previous versions of the GDP, we now have an increased focus on the control of various temperatures and on the safety and security throughout the entire supply chain. “Regardless the mode of transport, it should be possible to demonstrate that the medicines have not been exposed to conditions that may compromise their quality and integrity.” (GDP, 9.1)
Major changes to the draft guidelines
Major changes to the draft guidelines are:
Usage of transportation hubs: “limited to 24 hrs” has been replaced by “minimize the duration of temporary storage while awaiting the next stage of the transportation route” (GDP, 9.2)
“Transport according to label claim” has been rephrased to “the required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer package” (GDP, 9.2)
“The availability of the responsible person and his duties” has been rephrased to “The responsible person should be continuously contactable. He may delegate duties but not responsibilities.” (GDP, 2.2)
It is clear that the new GDP will have a strong impact on the distribution of medicinal products. I will elaborate on the impact of these new EU GDP and the aforementioned major changes to the draft guidelines in a future blog post.
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Luc Huybreghts has been working in the pharmaceutical industry for more than 25 years. As a subject matter expert for temperature-controlled storage, transport and distribution Luc now uses his experience to develop strategies and implement qualified solutions for top clients in Belgium and beyond.
Luc is a regular invited speaker at pharmaceutical conferences around the world.