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.

Validation of the entire transport chain

Agidens offers manufacturers of pharmaceuticals and medical devices and specialised transport companies an integrated solution for transport validation:cold chain validation:

• Thermal mapping of warehouses, cold storage, cross docking, etc.
  • Mapping cold spots and hot spots
  • Impact of worst case scenarios on the basis of alarm simulations
  • Impact analysis of temperature increase on cargo
  • Influence of outside temperature
• Validation of the monitoring system
  • Validation software
  • Correlation between monitoring system and mapping
• Validation/mapping of the entire fleet
  • mapping the fleet
  • Validation of temperature tracking system
  • Correlation between lorry temperature and monitor temperature
  • Load and design advice
• Validation and mapping of other appliances such as refrigerators, ovens, incubators, freezers, -80°C - freezers, temperature control fridges, etc.

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.

Why Agidens for transport validation/cold chain validation?

• Agidens is a specialist in logistics processes and the management of supply chains.
• Within our Life Sciences department we have specific knowledge about (thermail) validation and compliance. We have received some great references for this.
• Our Energy & Sustainability consultants can advise you immediately in setting up an energy efficient transport chain.