6.1.2. Vision and mission

The vision of top management to improve quality beyond GMP quality for medicines that matter was translated into a mission to agree on a set of simple principles and processes for how to develop, review and challenge research programs in order to secure smart design and critical path thinking while research quality as well as GMP quality is naturally built in to the plan and its execution.

This mission was detailed in programmes to establish technical risk assessments and mitigation plans for all CMC teams and to ensure the same quality in all projects. These were finally all combined into a single program, when rolling out a QbD based development throughout all CMC development activities starting at the nomination of a compound as a candidate for clinical development.