ASSESSING POTENTIAL COSTS ASSOCIATED WITH IMPLEMENTATION
Running parallel with the benefits assessment is the assessment of potential cost in the cost-benefits analysis. The same
issues apply relative to building a credible estimate to enlist top management, particularly finance, in the opportunity QbD
The assessment of cost is more challenging to nail down than the estimate of benefits, however. When assessing benefits,
a company has the advantage of historical perspective of costs incurred due to delays and product losses in areas with well
In assessing implementation costs, one needs to estimate the cost of transitioning the organization from its current level
of technical and organizational readiness to that which will be necessary to effectively execute a QbD strategy.
The FMEA developed in the benefits assessment can be useful in assessing potential costs as well. Identifying mitigation
strategies to address potential failure modes and risks identified in the FMEA will, in turn, highlight gaps in organizational
readiness and design for which corrective action costs can be estimated.
Figure 1 illustrates the major considerations in functional coordination associated with mitigating risk and executing a transition
to a QbD strategy. Each organization will be at different places on the continuum of readiness to implement these elements
and each has its own associated costs.
Figure 1: Cross-functional coordination involves support across all divisions.
Considerations include not just the gap in technical know-how, but also issues related to change-management and the speed
with which the organization can make the transition. Organizational transformation to adopt QbD will probably involve changes
in organizational design and in cross-functional interactions. Such changes can encounter strong resistance by those attached
to the status quo.
Temporary outside assistance to smooth these issues and facilitate change may help accelerate transformation and reduce cost.
Particularly complex products or processes may require extensive experimentation and more time in development to adequately
characterize the process and present acceptable data. Inexperience both internally and within FDA may cause delays in first-time
QbD-based submissions, a potential cost that should not be overlooked.
Finally, upgrades of software and data-management systems may be required to allow integration of historical data and to facilitate
cross-functional coordination. These potential costs need to be considered as well.
In the weighing of costs and benefits, it has been our experience in working with many life sciences companies that the organization-specific
benefits of QbD almost always far outweigh the costs, yielding an ROI that continues to grow year after year.
However, the great magnitude of the potential benefits does not mean that the organization should immediately undergo massive
transformation, a giant step that many leaders and decision-makers may be unwilling to take up front. Instead, one can adopt
a phased approach that allows the company to move confidently toward a fully integrated QbD strategy.
Organizations can begin by building technical competence in basic process characterization, designed experiments, and hypothesis
testing ahead of full scale QbD-submission preparation. Once those methods and techniques have been mastered, the organization
can undertake QbD process development but also can continue to file with FDA in the traditional way. In the final phase of
development, a company can embark on QbD-based filing.
It is important to understand, however, that there is a balance which needs to be achieved. Yes, there are costs and risks
associated with organizational transformation but the full benefits of QbD will not be realized until the final phase, in
which filings are fully QbD-based. Organizations that evolve slowly will reap some benefits along the way but will remain
at a competitive disadvantage to those with a more aggressive transition strategy.
James P. Catania is a managing consultant at Tunnell Consulting, firstname.lastname@example.org