7.2.2. Which functions are the initiators and stakeholders of the QbD roll out?

When asked how the QbD initiative had been started within the corporation a clear trend demonstrates that pharmaceutical development or other departments within the technical or CMC development area were the key enablers and promoters of this in the majority of all cases. As more than one function could be cited for this question (paying respect to the fact that it is often a joint initiative from more than one function) the answers in Table 9 clearly confirm this multidisciplinary approach in most companies.

Table 9: Responses to question 4 of questionnaire: “Which function(s) in your company did initiate or facilitate the roll out of QbD? (Please, tick up to 3 options and specify the reason for using a consultant, if you did use external consultants)”

While Pharmaceutical Development or CMC were, except for 4 responses, always the initiator and major promoter of the roll out, other functions’ participation varied from company to company quite significantly. In most of the cases (58%) Pharmaceutical Development actually drove the roll out all by itself, and this was supported by other functions only in about a third of all cases. In 8 cases senior management had initiated or promoted the initiative and in 3 cases it was actually the main driver in doing so. In 5 cases QA was participating in the roll out, but was the main driver only once. Production was the driver in 2 cases and participated in the roll out in 1 other case. Project management, however, has in no case participated or driven the roll out as a main stake holder at all.

Out of all 31 roll outs, consultants were involved only in 2 cases, but the benefit of involving a consultant was stated explicitly by one of these responses, as to “ensure that our understanding of QbD would be in agreement with the ICH way i.e. to avoid reinventing the wheel”.

Altogether, the approach to roll out QbD in most companies still appears to be a functional CMC initiative and not an integrated, cross functional system approach, often also lacking the active participation from top management for this shift of paradigm. Mostly the roll out was driven by the scientific desire of the concerned functions, lacking management commitment and the integration into the quality systems and other corporate programmes. This also explains why especially those QbD elements referring to the philosophy of integrated systems, like QRM and PQS with its Knowledge Management and Continual Improvement are still missing in many of the roll outs.