Third development phase: identifying critical material attributes
Quality risk management applied to pharmaceutical product development

At this stage, various prototype formulations are proposed on the basis of the previously established elements (characteristics of excipients and active substance). The different phases of the process are identified and mainly comprise a granulation phase, a mixing phase and a compression phase.

The development strategy must enable the manufacturer to achieve the targets defined in the QTPP.

The choice of primary packaging is proposed and will be confirmed by container/content interaction studies. It goes without saying that the choice of primary packaging, together with the storage conditions, must guarantee the drug's stability (against light, humidity, etc.) until it expires.