6. Fifth development phase: industrial implementation and primary stability study

At this stage of development, the data previously obtained on a pilot scale means that the manufacturing process can be transposed to an industrial scale in line with Good Manufacturing Practices (GMP) recommendations.

Industrial-scale implementation is carried out in line with the established transposition strategy. At this stage, the criticality levels of the parameters (MAs and CPs) are confirmed and refined where necessary.

Batch productions of industrial size and representative of commercial production are placed in stability and studied according to the recommendations of specific ICH stability study guides under long-term (25°C/60% RH) and accelerated (40°C/75% RH)...