GDP-compliant pharmaceutical transport – what to look for

Medicines are among the most demanding loads in road transport. Apart from the temperature itself, procedures, documentation and driver training all matter. The framework for all of this is set by the Good Distribution Practice guidelines, or GDP for short.

What is GDP

GDP (Good Distribution Practice) refers to the European Commission guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01). Their aim is to ensure that a medicine reaches the patient with its quality unchanged. Chapter 9 of the guidelines covers transportation.

Temperature ranges

• +2…+8 °C for refrigerated medicines, including vaccines, insulins and many biological products.
• +15…+25 °C for medicines stored at controlled room temperature.

In both cases the temperature must be maintained throughout the journey, including in summer and winter, when the difference between the inside of the trailer and the outside is greatest. That is why medicines kept at room temperature are also transported in reefers that can both heat and cool.

Recording and calibration

The temperature in the trailer is logged by a recorder for the entire duration of the journey. The recorder should be calibrated regularly, and the record kept and shared with the shipper. Before loading, the trailer is brought to the required temperature.

Temperature excursions

If the temperature goes outside the permitted range, the carrier must report it to the shipper according to the agreed procedure. The shipper's quality department decides what happens to the goods, based on the recorder data. That is why it is so important for the record to be complete and legible.

Cosmetics and other sensitive goods

Cosmetics, supplements and household chemicals are not covered by GDP, but they often have similar temperature requirements. Creams, perfumes and chocolate do not tolerate heat or frost well, so in practice they are transported under the same conditions as medicines at +15…+25 °C.

How to choose a pharmaceutical carrier

• Does the carrier know the GDP guidelines and have procedures for handling excursions?
• Does the trailer have a unit that can both heat and cool, and a calibrated recorder?
• Are the drivers trained in transporting medicinal products?
• Is the temperature report sent to the shipper after every trip?