Temperature-Sensitive Pharmaceuticals – Transport and Vehicle Qualification - Online Training Recording

It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into Play.

The distribution of temperature-sensitive pharmaceuticals is extremely challenging. The EU GDP-Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use) require that if temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out, taking into account seasonal variations. For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature controlled vehicles) should be used to ensure correct transport conditions.

The approvals of various COVID-19 vaccines in many countries at the beginning of 2021 illustrated the importance of distribution of temperature-sensitive medicinal products – and the challenges involved. For example, how must these vaccines – but also any other temperature-sensitive product in general – be transported to get safely from the production sites to the storage and distribution centres and then on to the local vaccination centres?

The specific packaging, transport, handling and storage requirements as well as the transport routes may differ depending on the type of pharmaceutical product. In any case, transport companies must take special safety precautions for the transport of temperature-sensitive pharmaceuticals. The products are often not only very valuable, but also particularly sensitive. Damages can quickly lead to a total loss, as in case of doubt, the entire load must be destroyed. In addition, there are risks such as interruption of the cold chain. Therefore, the products may only be distributed with controlled packaging solutions and in special vehicles that are appropriately qualified and whose temperature is monitored permanently.