Pharmaceutical transport in times of climate change
Due to the prevailing climate change - even a climate crisis - more and more extreme weather conditions are being experienced and measured not only in Germany but worldwide. After GMP production, which is controlled down to the smallest detail, the final step is delivery - to wholesalers, to pharmacies, to patients. And if this delivery does not take place in a controlled manner, all the effort and the detailed set-up in advance was for nothing: patients ordering medicines for a disease are supplied with medicines of reduced quality - or do not receive them at all.
The GDP guideline in 2013 made transport more controlled and increasingly stringent due to a plethora of requirements for the qualification of transport packaging and vehicles, as well as the validation and verification of transport processes. Many medicines, such as the vaccines that have recently been delivered in large numbers, are particularly sensitive and can become not only unusable but also harmful due to temperature deviations or excessive handling. And due to the increasing temperature extremes in winter and summer, the validity of established transport processes is being called into question.
Is your transport still appropriate and valid or have you perhaps not yet thought about this?
TentaConsult is happy to support you in setting up a new valid transport process or in reviewing existing distribution channels, individually tailored to your distribution - locally and worldwide. Here we include according to your needs:
- Quality risk management,
- qualification of packaging, vehicles, service providers and customers, and
- validation and verification of processes
to your planning, implementation, and final evaluation. If necessary, we discuss the results together and support you with corrective measures.