6.1. Generating a business case for QbD from candidate nomination onwards

The change from traditional development approaches in R&D to a QbD driven approach is driven by the desire to improve the quality of all development activities beyond GMP in order to improve the chances of success for projects. This mission then needs to be translated into a program to build strategies to achieve this objective.

A quality commitment from top management will be essential to be embraced by pharmaceutical development to roll out QbD throughout all technical development activities. The business plan for a roll out for all projects starting at the candidate selection stage includes a vision and mission statement, a SWOT analysis for the roll out strategy, the planned incorporation into the organisation, a milestone plan, and the associated costs and resources. Implementation starts after approval by and under the sponsorship of top management.