GDP Implementation: Harmonisation needed?

In 2013, the revised EU Good Distribution Practice (GDP) Guideline was published in the Official Journal. The extensive revision of the Guideline from 1994 has raised a lot of questions with regard to the implementation. One of the key topics deals with the storage of medicinal products.

In Germany for example, GDP implementation is laid down in the Trade Regulation for medicinal products ("in German called Arzneimittelhandelsverordnung"). Nevertheless, the German regulation doesn't set the scope of application for the term "storage". The scope of application in paragraph 1 states that the regulation applies to wholesale distribution facilities and establishments. The German Drugs Act (§4 section 22) defines the wholesale distribution of medicinal products as any activity, undertaken professionally or commercially, for the purchase, storage, dispensing or exporting of medicinal products - expected from supplying medicinal products to other consumers than doctors, dentists, vets or hospitals. The wording "professional or commercial purpose" limits the scope of application.

This scope of application isn't in line with article 1 section 17 of the EU Directive 2001/83/EG which defines the wholesale distribution of medicinal products as "All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public..."

What about companies which only serve as storage and don't run any wholesale activity of medicinal products? There are many such warehouses which are run by service providers. It is undisputable that these warehouses have to implement GDP. Manufacturers of medicinal products have to control their compliance; in the end, the GDP requirements are also applicable for them as part of the distribution of their own medicinal products. What about the competent authority? In principle, the organisation which runs the warehouse can apply for a GDP certificate. Other partners in the supply chain may claim the GDP certificates - particularly when other EU countries are involved. After all, the GDP Guideline requires that one should inform herself/ himself about the suppliers and customers and their permission to handle medicinal products. The easiest way to do this is by using a GDP certificate.

Nevertheless, GMP/GDP monitoring authorities in Germany and maybe in other EU Members States as well seem to have difficulties in issuing a GDP certficate for such warehouses. Indeed, the current legal situation (as mentioned above for Germany) doesn't provide a basis for GDP inspections. However, in other EU countries external "warehouses" are subject to GDP inspections because of the national legislation and thus receive a GDP certificate which is published in the EudraGMDP database.

Another hot topic is the question when a hub becomes a warehouse and is thus subject to GDP? The sheer volume of hubs in the global supply chain makes full GMP supervision impossible. But fact is that medicinal products are stored in such hubs more than just a few hours. What if medicinal products are stored over a weekend?  Beside variations in temperature and humidity as well as further parameters, the access to these premises is often not sufficiently secured. Many persons have access. A controlled access - as required in the GDP Guideline - isn't often guaranteed.

In Germany as maybe in other countries as well, there are no official limits defined which state the maximum time for storage in a hub. It is generally acknowledged - even though not defined in writing anywhere - that an up to 24 hour storage in a hub is possible without any authorisation for the hub. So far, only the British Health Agency (MHRA) has put it in paper (here 36 hours are defined as a maximum). Please read more in our GMP News about MHRA position on freight consolidation depots.  However, this guideline doesn't apply in any other European countries.

It would be desirable when - in terms of medicinal products safety - a more precise wording of the requirements and an (EU-wide) harmonised GDP supervision would be in place with regard to hubs and warehouses. One could also consider that insufficiently secured stocks of medicinal products may fall into the hands of criminals. One of the key objectives of the GDP Guideline was to finally exclude such cases as far as possible (to fight against counterfeit medicines). But these gaps in implementation might cause a risk to patient safety.

If you know about similar issues in other EU countries please contact us at info@gmp-compliance.org