Démarche de qualification d'un colis pour le transport de médicaments anti-cancéreux dans le cadre d'un essai clinique

The aim of this study is to secure clinical trial drugs shipping from a coordinator pharmacy to hospital pharmacies of investigator centers in France. The monitoring of each parcel temperature during shipping using an autonomous temperature logger has been decided. In order to validate this concept, a prior qualification of parts composing the parcel has been realised. Moreover, tests have been realised to design the parcel and the necessary cold environment for good shipping conditions. The result is a parcel able to maintain the temperature between + 3°C and + 24°C during 24 hours at an external temperature of + 50°C. The different parts of the parcel have been qualified and documented with procedures and quality documents. Then, the parcel configuration has been adjusted with the result of temperature loggers because of seasonal temperature variations.