Luc, in March last year we discussed the new EU Guidelines for Good Distribution Practice (GDP) of medicinal products on this website. Can you refresh our memories about the content of these new GDP guidelines?
The new EU GDP guidelines are much more extensive and detailed than the previous version of the guidelines. The three main differences are:
There is more emphasis on risk assessments;
There is more emphasis on the role of the responsible person;
There is more emphasis on transportation requirements. The requirements for temperature controlled distribution apply not only to cold chain (+2°C to +8°C), but also to different temperatures, including +15°C to +25°C.
The new EU GDP guidelines were published in March 2013. Are pharmaceutical companies compliant with these regulations now?
That’s the idea. The new EU GDP guidelines were published on March 7, 2013. This was followed by a transition period of 6 months during which the pharmaceutical industry had to implement the new GDP guidelines. If all went well, the pharmaceutical industry has been compliant with the new GDP guidelines from September 2013 onwards.
When can we expect the first inspections with regard to the new GDP guidelines?
After the publication of the new guidelines, the authorities needed time to translate the European guidelines into their national legislations. And they had to define an approach for their inspections.
In addition, logistical parties such as carriers and airports needed to adapt their products and service times to the new guidelines as well. This is why the first inspections are being carried out just now or will be carried out in the near future.
What should companies pay attention to when preparing for these inspections? What will inspectors focus on?
For GMP and GDP inspections, you should always take a close look at your quality management system. All procedures should be clearly documented and implemented.
All steps, components and actions should be in accordance with these procedures. And this must be verifiable, for example by means of documents of shipments performed.
But the publication of the new GDP guidelines changed a number of things, right?
Yes indeed. Now the inspectors will probably focus more on risk assessments, transportation requirements, and on the transport processes of ambient goods, which must be transported between temperatures of 15 and 25 degrees Celsius.
How can companies prepare for these new inspection points?
It is important to have a good risk-based approach for organizing your modes of transport and transport processes. Such a risk-based approach can be divided into three steps:
The different parts of the transport process must be visualized. You can think of the various modes of transport, storage, and transport handover points.
For each part of the transport process, the variables that affect the transport must be described. On the one hand you have product-related variables such as the type of product and the stability of the product. On the other hand you have the process-related factors such as the outside temperatures in different parts of the supply chain.
For each part of the transport process, a risk assessment must be carried out, using for example a Failure Mode and Effects Analysis (FMEA) approach.
It seems challenging to implement the new GDP guidelines while maintaining operational efficiency!
This is one of the biggest challenges to the pharmaceutical industry. On the one hand we need to be compliant with international guidelines, on the other hand we have a range of logistics services that may not be fully compliant yet. And evidently every pharmaceutical company needs to strive for operational efficiency to be able to supply patients with products on time.
Therefore pharmaceutical companies are now considering smart solutions that hit the right balance between compliance and operational efficiency.
That’s what your workshop at the Cool Supply System & Solutions 2014 Conference is all about, isn’t it?
We will discuss what GDP inspectors consider important
We will discuss how pharmaceutical companies can prepare for an inspection
We will look at examples of compliance issues
We will discuss different types of audits by the authorities and by clients from the pharmaceutical industry
Where can people register for this workshop?
You can register for the Cool Supply Systems & Solutions 2014 Conference at www.cold-gdp.com. Our workshop will take place in Brussels on March 19. I look forward to meeting you in Brussels!
Questions or suggestions?
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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.