According to RDC 430/2020 and 653/2022, all those involved in the production and logistics chain must communicate and exchange information in order to maintain product quality throughout the entire process, from manufacturing, storage, transportation, and distribution of medicines. Based on these RDCs, everyone becomes responsible for maintaining parameters that ensure cargo stability.
The objective of route qualification is to evaluate temperature maintenance throughout the transport of the product/medicine and to identify the main risks and critical points during the operation.
The first step for efficient route qualification is to develop a risk analysis to analyze:
The main routes used in routine operations;
Among other points that may be critical to the process.
After determining the routes for study, it is necessary to select the type of transport to be used, which can be active or passive.
Active transport refers to vehicles/containers that have refrigeration systems and a power source (electricity or other energy source) capable of maintaining the temperature of the medication during transit, which is possible through the use of thermostats.
Passive transport, in turn, refers to packaging containing thermal insulation/containment material, developed to meet the specifications of each product, with its configuration (amount of refrigerant material, minimum/maximum quantity of products, etc.) standardized according to the transport time between storage and delivery to the end customer.
It is important to note that for active transport, thermal qualification of the container must have been carried out, and for passive transport, thermal qualification of the packaging must have been carried out.
It is recommended to perform the qualification in at least two periods, summer and winter.
MGC can assist in all stages of route qualification, from route analysis, risk analysis, thermal qualification of vehicles and packaging, among others, to route qualification itself.
