3.3. Strategies for the roll out of QbD and their advantages and disadvantages

In principle there are four different strategies that may be applied to implement a QbD driven development in a company.

1. Complete roll out of an integrated QbD approach will definitely achieve the biggest effect and enable a company to make full use of the associated benefits. However, it will also be the most complicated, costly and capacity intensive approach that so far has been pursued mostly by big companies only.
2. Step wise but completely integrated roll out of QbD starts setting up the various elements of QbD one after the other over a longer time period. Starting with the most straight forward elements such as QTPP and risk assessment this allows a company to limit costs and resources at the beginning and to utilise learning effects for the implementation of the next steps. However, it will also take longer to see the full benefits and it may be difficult to maintain contribution of all stakeholders especially when benefits are not visible quickly.
3. Implementation of individual QbD elements, such as risk analysis or DOE as sole elements without the intention to pursue full roll out of QbD, is a straight forward way to achieve benefits from these elements that can be perceived quickly at relatively low costs. However, isolated tools can not achieve the desired improvement in the long run especially when they are not integrated into the architecture of the organisation.
4. Starting with a pilot project to assess the potential benefits and challenges of QbD can be established as a model without disrupting the normal processes, thereby establishing a safe learning space. However, costs and resources needed to do so are considerable, while potential benefits remain isolated to one project, which also provide a limited overall benefit.

The presented case studies are going to describe two different approaches, based on scenario II and III.