Quality by Design: The Case for Change (Part II)

A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
May 01, 2011
Volume 24, Issue 5

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:

James P. Catania
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.

A business case for implementing a QbD approach essentially involves development of a cost-benefit analysis encompassing the following:

  • 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.


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 planning.

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.

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