7.3.3. Experiences gathered to date with QbD?

In that context the major concerns still refer to the increased development costs and additional time needed for the increased scientific investigations and use of analytical tools. And of course many companies “are still on a learning curve” needing experience with “additional products reaching filing/launch stage” and some just have started implementing QbD recently and are thus in “the initial stage of implementation and learning” or “just in the process of starting QbD”. However, there is also a growing awareness that “more education is necessary” and “implementing a QbD mindset” is needed, especially in order to get it implemented “company wide”. This will be also essential to overcome the “poor acceptance of QbD methodologies because of lack of respective knowledge”. On the other hand the same lack of experience and clear understanding is also blamed to the regulators in the authorities, which makes it challenging “getting submissions to the right detail”. There is “still limited acceptance of Design Space by regulatory authorities” and “additional (traditional) work was required for other markets”, increasing the resources needed for a worldwide marketing submission even further. When “submission is lacking” the full benefit for the industry from the new approach is obviously yet to be seen.

From the 4 replies that did not see their expectations fulfilled and are not expecting this to happen any time in the near future any more, the most obvious reason was the associated costs. Not having been able to achieve the goal of reducing costs by the implementation of QbD often outweighs potential benefits in the product quality especially in the high cost pressure area of generic products.

Also, for a CMO developing biopharmaceuticals hoping to increase time to market this promise of QbD appears to be unachievable, applying it only on a case to case basis or for trouble shooting as they are dependent on customers’ support for a QbD driven development. However, not having defined their expectations clearly themselves yet also makes measuring of any benefits unrealistic.

Even companies that have implemented QbD as a systematic approach and actually filed QbD applications see their expectations not being fulfilled within the near future as QbD is seen to be “very resource intensive and as a result going forward will only be used for limited products”.

Summarising this outcome it appears that substantial benefits are experienced by very few of the adopters so far, while the majority of companies is still waiting to see how QbD can improve profitability and profit growth beyond its clear advantage of improved product quality. However, even this improved quality is still not seen to provide any substantial competitive advantage as the additional costs and the lack of regulatory harmonisation and communication outweigh these by far.

So obviously there is still substantial work needed to resolve these obstacles and more successful models of QbD adaptation are needed to drive the further spread of this imitative throughout the industry. None of the responses has tried to combine the QbD approach with the paradigm of Minimalism, trying to focus on the most critical and thus most important activities at a time. The potential of reducing costs already during development by such an approach is still missing and no calculation of improved success rates, though this is clearly a goal desired by many, has been approached so far.