7.3. The intentions behind the roll out?

Question 7 focuses on the reasons for implementation, i.e. which benefits the company hoped to obtain in doing so. The question requests selecting only the most important reason and then to specify this in more detail in order to reflect on the most imminent need each company is pursuing.

The technical limitations of having to limit the survey to 12 questions made it impossible to separate those two aspects into two different questions. Therefore, the number of allowed ticks for this question is limited to two instead of one, which resulted, however, in the majority of participants to tick more than one option instead of using the second tick box to explain their selection. As a result of this the number of responses for each of the options now exceeds 31. No weighing of the selected two options could be recognised when evaluating the responses and therefore all selections of each option are counted together in the table below.

Table 10: Responses to question 7 of questionnaire: “Why did your company implement a QbD driven development approach?”

As Table 10 demonstrates most companies rolled out QbD to either improve the quality of their drug products (> 50%), and/or to receive regulatory benefits in return for providing additional information derived from the QbD approach in the dossier (> 25%), and/or to increase the success rate of projects either during development or during filing. Despite the request to explain their chosen selection most responses did not provide further details for their selection.

In summary, however, most companies indeed seemed to focus solely on the improved quality and reproducibility of this quality. In combination with this improved quality they hoped to obtain increased regulatory flexibility for the marketing applications of their drug products.

A limited number of responses also specified their intentions into the direction of increasing efficiency and/or reducing costs and mentioned “reduced cycle time”, “better process controls and capability”, “reducing waste of time by development loops”, risk of failure elimination”, “fewer failed batches, reduced COGS”, “increased speed to market” and “to make FDA post approval inspections more successful” as motivators beside the pure quality aspects. As such, the huge potential of QbD to actually reduce development timelines, improve success rates and reduce costs in development and production were – even though by no means the main drivers - at least important for the decision to employ a QbD driven development strategy in about 58%.