Medicines are susceptible to variations in ambient temperature during their production and distribution processes. This can greatly affect the quality of the pharmaceuticals. Therefore, the logistics and distribution of medicines is subject to strict regulations (GDP 2013/C).
On of the biggest challenges is the revised GDP guidelines is that the product must remain within the provided specifications throughout the entire supply chain. This pretains to both chilled products and products which should be stores at room temperature. Any deviations to this should also be treated appropriately. Agidens can support you in both the qualification and validation of this.
Agidens offers manufacturers of pharmaceuticals and medical devices and specialised transport companies an integrated solution for transport validation:cold chain validation:
The validation is, of course, performed and documented according to GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices). Depending on the customers' expectations, we take a good look at the whole distribution process or focus on a particular aspect.
and get an answer within
three working days