GDP goes Europe

The revised EU Good Distribution Guideline went live almost two years ago. In the meantime many national health authorities and associated bodies have worked on guidance documents and codes of conduct to provide support and assistance in implementing it. We all know that the EU GDP Guideline leaves room for interpretation. The publication of frequently asked questions (FAQ) is one prominent way to share the national view.

In an additional layer, national attitudes can be taken from various codes of conduct. In this short paper we will concentrate on Germany, Austria, France, the United Kingdom and finally Ireland and their national views on its implementation.

Germany

Up to now Germany has not published any code of conduct or FAQ, but a couple of publications by organizations reflect current opinions. In Germany the risk-based approach is favored when addressing key issues of the EU GDP Guideline.

Let us take transportation as an example: Long-distance and last-mile transportation routes (from wholesale distributors to local pharmacies) are considered to be subject to different levels of risk. Especially for short last-mile routes, it is assumed that for 15-°C to 25-°C products no additional technical equipment for cooling is required to maintain ambient conditions. In case of temperature excursions, most ambient products are considered to be robust enough to tolerate such excursions and that negative impacts on the pharmaceutical quality will be the exception rather than the rule.

Of course, some parties favor a different understanding; some have learned their lessons from inspections and audits. These parties strictly respect the labeled storage conditions during transit. The fundamental question is: Why should last-mile transports be treated in a different way?

Austria

In 2014 the Phago (Association of Austrian Wholesale Distributors) and the Pharmig (Association of the Austrian Pharmaceutical Industry) published an updated codex, defining nonbinding requirements for the national transport of pharmaceutical preparations, for transports within Austria.

Looking for statements on the transport temperature we find the following: Short-term deviations of the temperature range 2 °C to 30 °C (up to 12 h) are accepted for ambient 15-°C to 25-°C products. The authors, however, admit that even this broad temperature corridor cannot be maintained without any technical support and adaptation of the processes concerned, in particular when standard courier service providers are engaged. The credo of voices critical of this time span is that 12 h by no means are short.

United Kingdom

The MHRA (Medicines and Healthcare Products Regulatory Agency) treads a different path; it has published FAQ on its website. Let's first focus on storage during transit. In the eyes of the MHRA, 36 h are the deadline, for longer storage a relevant wholesale distribution authorization is required. In Ireland the deadline is 48 h; in Germany 24 h, although in Germany interpretation is not stated explicitly in any document. The discussion includes annotations on mean kinetic temperature (MKT) and its role on handling deviations. MKT should not serve as an excuse for poor logistics. Deviations from storage or transport temperature can be evaluated only on the basis of valid data (temperature records and stability data).

France

In France the path to the revised EU GDP Guideline was already prepared by the publication of the "Bonne Pratique de Distribution en Gros" in 2000. In Chapter 1.2 g) we read the following: "Les conditions de conservation sont respectées à tout moment, y compris au cours du transport."

This statement clearly indicates the assumption that storage and transport temperature should be treated identically, thus when the storage temperature is fixed at 15 °C to 25 °C, the same range should be respected during transportation, as stated in Chapter 5.13, Deliveries.

Ireland

The HPRA Ireland (Health Products Regulatory Authority) published its GDP guidance document "Guide to Good Distribution Practice of Medicinal Products for Human Use" in April 2014. It goes through the guideline chapter by chapter. It also includes sales representatives' and doctors' samples.

Lessons to be Learned

After the EU GDP Guideline came into force in November 2013, 2014 was the year of interpretations and codes of conduct or FAQ. We presume that in 2015 we will learn a lot from the GDP audits and findings of noncompliance - and the effect this will have on pharma logistics.

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