Implementing the New EU GDP: Challenges faced by Pharmaceutical Wholesalers
The revision of the European Good Distribution Practice guidelines is having a significant impact on the medicine supply chain in Europe. Some of the key aspects of the new GDP are its extended scope of application (involvement of more supply chain operators) and its level of descriptive detail for many of the new requirements. As with any regulatory revision, operators must adapt their systems and processes for the purposes of compliance. This is often easier said than done. GIRP, the European Healthcare Distribution Association, is the representative voice for pharmaceutical full-line wholesalers focusing on the last mile distribution. By definition their delivery units carry a wide range of different products that often require varying temperature ranges for storage.
As shown in the graph, there can be as many as 60 different temperature indications for medicine storage in a single European country. As a delivery from pharmaceutical wholesalers to a pharmacy comprises on average products from 19 pharmaceutical manufacturers, this is a challenge that is not easy to meet.
GDP Chapter 9 specifies that “storage conditions for medical products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging”. The GDP guidelines do not distinguish between transports from the North to the South of Europe and the transport from the warehouse to the customer. This lack of distinction and the absence of timeframes for the duration of the transport has an immediate and deep implication for last mile distribution where product bundling takes place.
Pharmaceutical full-line wholesalers do not have access to the stability data of pharmaceutical manufacturers and even if this was the case, the in depth analysis of several thousand products’ stability data for deliveries from the warehouse to the pharmacy would be out of proportion. In this respect it is worthwhile to note that the average delivery time in the 5 largest EU countries is extremely short, averaging 2.4 hours ,and most CRT (15-25°C) products would not suffer from a short deviation in the range of 2-30°C. Of course, cold chain products are always distributed strictly according to their precise temperature requirements (2-8 °C).
Pharmaceutical full-line wholesalers therefore ask the pharmaceutical industry for precise instructions concerning the sensitivity of their products with respect to short term temperature deviations, as otherwise the information provided on the outer packaging serves as the only indication. This requires substantial investments and may be disproportionate to the aim when minor deviations to a minimum lower or maximum upper temperature beyond the stated ranges over a specified (short) time period will not have any impact on the quality and safety of the actual contents.
GIRP is therefore calling for a collaborative approach in the area of transportation, where there is a clear need to work together. Healthcare distributors, manufacturers and inspectorates have to find pragmatic, workable solutions that ensure the quality and safety of products while facilitating the efficiency and cost effectiveness of last mile distribution.
Therefore, all members of the pharmaceutical supply chain should partner together to meet the new challenge created by the implementation of the EU GDP
In order to help facilitate supply chain collaboration and to initiate dialogue on the feasibility and workability of enhanced labelling instructions for products, GIRP will launch its first ever GIRP Educational Academy (GEA) conference on 16th-17th March 2016. The conference entitled “Joining Forces for Transportation Optimisation in the Pharmaceutical Supply Chain” seeks to initiate an exchange of views with the pharmaceutical industry and regulators in an attempt to find a mechanism that enables all supply chain partners to ascertain product safety and quality during the last mile. Further information can be found here: GIRP EU Supply Chain Conference.
Author: Monika Derecque-Pois, Director General, GIRP European Healthcare Distribution Association