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7.4.2. Why is QbD still not fulfilling ist full potential, producing significant return on investment
Among the explanations for what is needed to support the widespread adoption of QbD throughout the industry, the responses showed a similar focus as already indicated in question 11.
There are 4 major areas of deficiency addressed by these responses in Table 13:
- Increased development costs and potential savings not apparent yet
- Lack of regulatory harmonisation and consistency
- The required change in the mindset how to develop drug products in the future
- Missing methods for and examples of measuring ROI
| Deficiency category | Comments on the perceived hurdles to turn QbD into a success story for the pharmaceutical industry |
| costs | “Quality is amazing, but to justify $$ is difficult” → expectations are seen not to be fulfilled in the near future for a generic company that hoped to reduce costs by applying QbD |
| “To reduce costs more experience is needed, as we are still very much at the frontier” | |
| “In depth understanding of related principles is needed to improve development timelines and reduce wasting time by development loops” | |
| “QbD is an approach only big companies can afford and far beyond the possibilities of small or mid size companies and CROs or CMOs” → this is the opinion of a company that has not yet started the roll out and does not plan to do so | |
| “Best practices for utilization of prior knowledge are needed to achieve a reduction of costs during development” | |
| “Based on business case we prepared the return on investments necessary will only pay back in many years” → however expectations from QbD have not yet been defined and approach is used only in some cases | |
| regulatory | “People are afraid of change and regulators do not fully understand it. Especially with departure of key staff from FDA who were hoping for better quality in products and improved processes” |
| “I am sceptical if regulatory changes are really easier if that means that much more needs to be QbD” → hoping for increased success rates during approval but applying QbD only for some cases | |
| “Authority bodies talk a lot about the QbD benefits but don't act accordingly” . → hoping for improved success rates for submissions but have not filed an application yet | |
| mindset | “First and foremost thing is to de-learn the process development by OFAT, random way of development and reorient the scientists to apply and visualise the benefits of application of ICH Q8 (DOE) and ICH Q9 Quality risk management techniques in process/product development. Once these two are digested it can be formalised much more and others can be added slowly. It is a slow and cautious process of adoption of QbD.” |
| “This is a culture change. The tight project timeline sometimes makes this difficult to implement. A good QbD roadmap that is actionable is also in need. Having hoped to let science drive product development to gain improved understanding and robust product/process” | |
| “Lack of awareness about QbD advantages in the industry” → fully satisfied with returns hoping for improved quality despite clearly increased costs for development | |
| “It is a useful tool for certain aspects of technical product development but I do not see a need for a full QbD submission (from a technical perspective).” | |
| ROI | “More case studies to see ROI” → hoping for improved quality and success rates |
| “Improved success rates appear to be true but can not be measured” | |
| “The return on investments is very difficult to estimate and calculate. It has not been fully satisfying to use the ROI approach so far” → hoping for improved quality and regulatory benefits |
Table 13: Responses to second part of question 12 of questionnaire:“What is in your opinion still missing to achieve a widespread adoption of QbD throughout the pharmaceutical industry?”
Although expectations from QbD are varying throughout the responses the obstacles to the widespread adoption are quite similar, focusing on those 4 areas.
Not being able to actually measure the ROI is probably the most striking deficiency but also requires a clear definition on the expected gains. The rules of S.M.A.R.T.73 criteria for projects are widely accepted throughout the pharmaceutical industry, but obviously these have not been applied effectively when rolling out QbD in most companies, yet. This makes Migliaccio’s demand74 for a clear business case appear to be even more important in order to obtain widespread acceptance in the pharmaceutical industry - for a philosophy that has already proofed wildly successful in most other modern industries. Furthermore, definition of expected benefits from this approach have so far focused too much on the improved quality and hope to receive regulatory flexibility and risk based decision making from regulatory bodies, when they themselves have not yet fully adopted the new paradigm.
In my personal opinion the huge potential QbD can really provide lies in the savings during development activities. When applying it to do the right things at the right time and thereby getting things „right first time“, this needs to be enabled by a fully integrated quality approach and a risk based decision making combined with Minimalism thinking. But, such a philosophy still needs to be fully embraced and supported by measuring the actual savings and ROIs.
73 Doran; There's a S.M.A.R.T. way to write management's goals and objectives; pp. 35-36
74 Migliaccio; QbD is still in its Adolescence; 2011