Risk assessment on transportation routes, is the determination of quantitative or qualitative estimate of risk related on the transportation process. It provides the companies with the required knowledge to implement the corrective actions to minimize the risk and guarantee the quality of the product while been distribute.
The Royal Ordinance 782/2013 of medicinal product for human use includes the implementation of a Risk Assessment System, adapted to the company and its activities, as a
mandatory aspect for every distributor company in the sector.
Risk assessment on transportation routes is a must on the medicine´s transportation chain. Qualipharma offers a comprehensive support for implementing the risk assessment based on ICH Q9 methodology.
It includes the characterization of the processes carried out by the client, the identification of the risk associated, its evaluation and the required consulting service to determinate the actions to be carried out (transport validation, warehouses qualification, etc).
Qualipharma with its multidisciplinary team of experts, is at the service of the clients to implement the Risk Assessment on transportation routes and offers a global support service to determinate and implement the actions and measures to be taken.