The right temperature for sure
Active temperature control is particularly important for the GDP-compliant transport of pharmaceutical and medical products. If the temperature is not controlled and regulated without interruption, this can result in a loss of quality in the transported goods, which would be fatal, especially in the case of medicines. Within the scope of a network validation, GDP network solutions was able to prove that during the shipment of a dummy pallet - within three weeks across Germany with several envelopes - the temperature range between + 15 °C and + 25 °C can be consistently maintained.
"As a transport service provider for pharmaceutical goods - such as medicines or high-value products - we strictly adhere to the EU's GDP guidelines for the good distribution practice of medicines for human use," says Jürgen Oetzel, managing director of GDP network solutions. These require that equipment, procedures and processes be qualified or validated before use and after any significant change or maintenance. "Our core process is temperature-controlled transport. Thus, we have the obligation to prove that our temperature data is resilient."
Dummy pallet for pharmaceutical transport
In the course of validation, a 285 kg Euro pallet consisting of 56 packages on seven layers was fitted with 17 data loggers - 15 of them inside and two outside the boxes. It was transported over 8,454 km between the branch offices and the main transshipment point in Kassel. In the process, 46 legs and 36 transshipments were realised. Temperature data from 365 hours and 7,776 measuring points were collected and evaluated. The transport took place under real conditions with loaded pharmaceutical goods. GDP network solutions successfully mastered the technical hurdle of integrating the data from various telematics systems into a central system in real time, as well as the required documentation.
The result: The temperature is correct!
Within the controlled period, the temperatures on the pallet were between + 18.9 °C and + 21.4 °C. The duration of the delivery corresponded to 21.81 hours on average. The proof that the promised transport can take place reproducibly in the network at + 15 °C to + 25 °C and a targeted throughput time of maximum 48 hours was thus provided within the scope of the validation. "Since our customers also have to fulfil special requirements - e.g. according to GDP, GMP, AMWHV or AMG - a network validation is of great benefit to them in order to qualify their service providers," Oetzel concludes. The temperature data can also be used for a detailed risk analysis. "With the evidence from the validation, we can not only fulfil our performance promise, but also prove compliance with the regulations from the GDP directive."
GDP network solutions GmbH is a nationwide pharmaceutical logistics network for the German healthcare market. In March 2020, ten medium-sized transport companies founded a nationwide cooperation. The fast, safe and temperature-controlled transport of medicines and high-value products between + 15 C° and + 25 °C is the core business of the network partners. Whether pallet or parcel - GDP network solutions fulfils the requirements of the EU's GDP guidelines for medicinal products for human use throughout the entire supply chain - from the manufacturer to the wholesaler to the doctor's practice. In addition to the reliable and on-time transport of medicines and medical devices from the field of human medicine, GDP network solutions also offers the ideal logistics solution for recipients and senders from the veterinary medicines segment with high quality and GDP requirements.