6.1.6. Costs of implementation: It’s not for free but it’s worth it

There is a clear understanding, that the roll out of QbD is associated with direct costs, which will have to be covered by the line functions and thus will be budgeted by line management. These initial direct costs for the roll out are expected to be:

• Consultancy fees for coaching of champions and training of CMC teams (≈ 200 hours)
• Software licences for both sites for DOE, QRM, multivariate data analysis + training costs
• 50% of champions’ capacity (= 1 FTE)
• Additionally, indirect costs in every project are expected for QbD compared to the costs for the traditional approach and these need commitment from the project teams and top management.
• Some slow down at the start of using QbD for a running project or when starting a new project
• More scientific understanding of compound and processes will be needed early on, thus adding resources for early phases of a project (front loading)
• Use of PAT tools (if these are needed for a specific project) will result in additional capital investments, personnel resources and operational costs for this project new project due to systematic process requests and essential contributions from other functions
• Early buy in of production unit is absolutely necessary to make it a CMC approach
• Increased QA resources will be needed for projects at early phases already to establish QA oversight and design validation