Quality by Design: The Case for Change (Part II) - A rigorous cost-benefit assessment can help to chart a cost-effective path forward. - BioPharm International


Quality by Design: The Case for Change (Part II)
A rigorous cost-benefit assessment can help to chart a cost-effective path forward.

BioPharm International
Volume 24, Issue 5, pp. 20-24


Too often QbD benefits are described in broad, idealized, hypothetical terms. This is exactly what we don't want to do if we are committed to rigorously addressing the fundamental concerns of top management and enrolling them in leading a transformation. Specifically, both the potential financial benefits and the potential costs to position the organization to effectively execute against a QbD strategy need to have sufficient rigor to obtain the buy-in of the finance team. Regardless of perceived benefit from the technical wing of your organization, if the CFO isn't on board, any effective integration of QbD into the organization's overall strategy and its associated organizational transformation impact is jeopardized before it begins.

A credible current-state analysis to identify and quantify potential financial benefits needs to involve an analysis of the organization's historical performance vis--vis the management of risk and life-cycle costing. A candid, forensic assessment tracing current products through research and development (R&D), scale-up, technology transfer, and commercial production will identify cases in which unexpected delays and costs were incurred which could have been avoided if the organization had been employing a QbD strategy.

Essentially, this is an estimate of the cost of poor quality (COPQ) associated with the organization's historical pattern of deviations and corrective actions but, unlike traditional COPQ assessments, the scope of the analysis is expanded beyond post-commercialization issues in production to include costs associated with regulatory filings, process development, and technology transfer early in the process of product development.

Products currently in development or undergoing technology transfer provide good examples for examination because these types of changes and actions are fresh in the minds of those involved.

The forensic assessment described herein need not capture every event in every product's life cycle to provide a credible estimate of opportunity. A few examples in which cost can be reasonably estimated can be more effective than many loosely quantified anecdotes.

Failure Modes and Effects Analysis (FMEA), in combination with COPQ, can be particularly helpful as well to extrapolate and estimate potential risks and associated recovery costs which could reasonably be avoided if the organization were to integrate QbD into its overarching competitiveness strategy.

FMEA is applied prospectively to an organization's product pipeline and late-stage development activities and considers the expected complexity of formulas/processes and projected regulatory filing requirements. Historical performance patterns established in the COPQ phase of the assessment inform the probability, detectability, and impact of failure in this FMEA exercise.

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