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