7.3.1. Experiences gathered to date with QbD?

Out of all companies that have rolled out QbD, only 9 (< 30%) have so far submitted a QbD dossier at a regulatory authority requesting either a marketing authorisation or a variation to an existing authorisation. This rather low ratio might reflect that the perceived benefits from regulatory flexibility are often lower than initially expected and that therefore the efforts needed to demonstrate QbD during submission outweigh these potential benefits. Thus some companies may have decided not to focus on QbD in their submissions despite pursuing it during development. Another explanation might be that many companies have simply not progressed far enough in their developments yet, to file a dossier since having adopted the QbD approach. Especially when bearing in mind that the majority of those companies has just started to apply QbD principles between 2008 and 2011.

Table 11: Responses to question 11 of questionnaire: “Please, describe your experience with the QbD driven development approach in relation to your initial expectations (Please, detail your response in the field below)”

When asked whether their expectations from the roll out of QbD have been fulfilled so far, the huge majority stated that they still expect this to happen within the next 1-2 years, though obviously the type of expectations will differ depending on the motivations for the initial roll out.

• So far only for 4 out of 31 adopters actually do consider the QbD approach to be a full success fulfilling their expectations. Another 2 companies stated to be fully satisfied as to the achieved improvements in the quality of their drug products, but to be still waiting to see the cost reductions and regulatory benefits to materialise.
• A company developing products for clients considers QbD, which was rolled out as a QA initiative, to be a full success for their intentions to improve success rates especially for pre-approval FDA inspections and thus uses it for all variations to existing marketing authorisations.
• A drug / device combination product company hoping to improve the quality of their products is also satisfied and “quite happy with the process”, having filed applications already, even though it does apply it only on a case by case basis as it considers QbD to be quite resource intensive.
• A biopharmaceutical company that has rolled out QbD for all development projects and variations is also fully satisfied as otherwise a “key product launch would not have been feasible”. QbD submissions have been filed already hoping for regulatory benefits and reduced costs, but QbD is only applied after phase II when the decision has been taken to actually file an application. PQS and QRM have been implemented at this company.
• A company applying the QbD approach to generic product development activities also stated to be fully satisfied in achieving their intention to improve product quality, even though no QbD submission has been filed so far.

The fact, that all of these fully satisfied responses are coming from companies, that would not naturally be considered to belong to the early adopter group for this new approach, is quite interesting to note. Generic drug products, device combination product development, contract development and biopharmaceutical product development often appear to be the most hesitant to adopt the QbD philosophy because of the increased costs and resources required. These are considered to be a real obstacle for implementation especially for those companies having to deal with extremely high cost pressure (CROs/CMOs and generic products) and limited resources for development activities (biopharmaceuticals, drug device combination products).

Interestingly enough however, all of these fully satisfied companies had implemented PQS, QRM, Control Strategy, the new validation approach and in one case even a formal Knowledge Management system. This represents the interpretation of QbD as an integrated system within the whole corporation, and not just reducing it to statistical or analytical tools. Obviously this integration enables these companies to fully benefit from the new approach, seeing their expectations fully fulfilled.