6.1.4. Organisational structure: champion approach and team matrix

To drive the roll out of QbD the selected approach initially nominates two champions from pharmaceutical development with different areas of expertise in QRM and QbD tools. In a later phase of the stepwise roll out additional champions may join from other functions to support them, adding other areas of expertise. In addition the roll out will be defined and supported by an external consultant, helping in the definition of tasks, the education of the organisation and the design of the best process for the stepwise implementation of QbD in the organisation. Continuing sponsorship of the roll out is granted from the senior line management of technical development and pharmaceutical development, acting as enablers at the management level.

However, the approach requires full support from all development teams in the matrix organisation with each team being requested and empowered to implement QbD in its project. Each of the teams thus needs to drive the implementation itself, while the champions can be approached by the teams for consultation and technical support in the use of QbD tools.

Thereby, a multiplication of the limited resources of the champions can be achieved and a simultaneous roll out can be done for all projects. The shared ownership requires however full commitment for QbD not only from senior line management but also from the head of project management and all project team members, both in the core project teams and the CMC sub teams. If upper management endorses the implementation, a strong support for this mandate can be expected from all stakeholders, i.e. project management, quality assurance and all CMC development functions.