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.

On Thursday 7 March, I was fortunate enough to attend the CSS 2013 conference in Brussels. In fact, I just gave a presentation on Temperature Controlled Transport – A Risk Mitigation Approach according to EU GDP (click here to view my presentation) when the new EU GDP were published. As a result, I found myself surrounded by an interesting group of people to discuss the highlights of the new GDP.

A brief overview of the new EU GDP

EU Good Distribution Practices - Pauwels ConsultingWe came up with the following shortlist:

  • The new EU GDP have the same structure and are aligned with the GMP regulation describing requirements for:
    • Quality system
    • Personnel
    • Premises and equipment
    • Documentation
    • Operations
    • Complaints, returns, suspected falsified products and recalls
    • Outsourced activities
    • Self-inspections
    • Transport
    • Brokers
  • 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  • Usage of transportation hubs: “limited to 24 hrs” has been replaced by “minimize the duration of temporary storage while awaiting the next stage of the transportation route” (GDP, 9.2)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 - Pauwels ConsultingLuc 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.


1 reply
  1. Kristopher says:

    All processes of the drug production/storage chain are equally important and all guidelines should be strictly followed. In general, there are many sources that can give you relevant information about GDP, GMP and others,( for example like this that are offered by Astra Nova Ltd), and all that is needed to be done is the people who are involved into these processes to apply and stick to the respective guidelines.

    Reply

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