5.1. Establishing QbD as a Design for Six Sigma approach

While the integration of QbD into the organisational architecture and culture are essential for the success of QbD, the first attempts to adopt the new paradigms were mostly done using QbD as an isolated tool to improve the quality of drug products. This was often facilitated by aligning it with Six Sigma principles coming either from the production area or other industries. And as already discussed in Chapter 2.3 both approaches actually do have many things in common and employ the same tools, too.

In such an approach Pharma Example started to integrate the steps and tools of Design for Six Sigma into the process flow for the pharmaceutical development of new drug products setting up a team with a Six Sigma black belt champion and a pharmaceutical scientist to outline the process.

Table 3: Correlation between DFSS and QbD

The intent pursued by the established process flow was to depict the individual steps of drug product development from a DFSS perspective and to define the pre-requisites, objectives and the minimum tools to be used at each state of development in a decision tree. Furthermore the intention was also to streamline the process and avoid deviations from the fastest route to success, which was believed to be achievable via the outlined process flow and the applied tools.