Second development phase: pre-formulation study
Quality risk management applied to pharmaceutical product development

The aim of this stage is to define the development strategy, with the ultimate goal of achieving the targets listed in the QTPP. It is at this stage that pre-formulation trials begin, as do the associated manufacturing processes. CMAs and CPPs are identified, enabling a risk assessment matrix to be drawn up.

As a basis for pharmaceutical development, knowledge of the constituents of the finished product is essential. Thus, the characterization of the active substance, including all properties likely to influence the QAQC of the finished product, must be assessed. Similarly, the composition of the excipients, their physical and chemical compatibility with the active substance, plays an important role in the quality of the finished...