Editor's Note: Part I of this two-part series ran in the March 2011 issue of BioPharm International. That article put forth
the following premises:
Organizations that recognize quality by design (QbD) as a necessary component of an integrated enterprise-wide strategy will
have a distinct competitive advantage over those who do not. Competitive advantage potential is not confined to manufacturing,
but rather, it permeates all critical aspects of enterprise performance from research and development (R&D) through commercialization.
The broad cross-functional implications of effective integration and the downside potential of ineffective integration and
functional coordination make leadership by executive management essential. Functional managers who understand the science
and technical implications must be able to translate that knowledge into the language of financial, operational, marketing
and strategic advantages that is the lingua franca of CFOs and other top leaders. In short, managers must be able to develop a business case. This article discusses that general
business case in more detail.
James P. Catania
A business case for implementing a QbD approach essentially involves development of a cost-benefit analysis encompassing the
- Organizational readiness to capitalize on the emerging compliance paradigm
- Clearly defining how QbD reduces risk and cost for the enterprise (i.e., product pipeline versus the organization's historical
cost and speed profile).
Beyond the general business case lie the challenges of engaging the larger organization in undertaking and developing the
specific business case for the company's particular situation and embarking on a QbD initiative. Those challenges include:
- Enrolling management in a more rigorous assessment of costs and benefits
- Developing a phased, integrated path to organizational competence
- Recognizing and achieving new paradigms in cross-functional coordination.
By making the general business case for QbD and mobilizing executive management to undertake its careful consideration, you
can not only help demonstrate to management the way to untapped business value but also greatly increase the scientific rigor
and competence of the organization's technical functions.
ELEMENTS OF A QBD COST-BENEFIT ASSESSMENT
For the purposes of this article, we are defining QbD as the submission to FDA of a design-space based validation as opposed
to a traditional three-batch validation. The assessment that follows, therefore, involves gauging the current state of the
organization in terms of potential financial benefits of implementing QbD and the potential costs to realize those benefits.
The objective is to achieve a strategic competitive advantage in the marketplace. Defining and implementing such a strategy
will require leadership from the highest levels of the organization. Any assessment must, therefore, rigorously address the
fundamental concerns of top management across all functional silos.
There are many who would argue that the strategic benefits of QbD are self-evident and, given the trend in industry and FDA's
endorsement to support the approach, organizations ought to make the transition as quickly as possible. Be that as it may,
it is still incumbent upon management to determine the cost and benefit of such a transition if for no other reason than financial
The following section outlines some major factors to consider when estimating potential costs, benefits, and return on investment
(ROI) with a QbD approach. Given the potential change-management issues that may arise during assessment, it is recommended
that a cross-functional governance structure involving upper levels of management be put in place to direct the effort.