How to Make the Business Case for Quality by Design - No time for QbD? How to convince management to make it a priority. - BioPharm International


How to Make the Business Case for Quality by Design
No time for QbD? How to convince management to make it a priority.

BioPharm International
Volume 21, Issue 12


When outlining business benefits, identifying and explaining the technology requirements needed for understanding the sources of process variability is critical to persuading corporate decision makers to give higher priority to a QbD initiative. There is an expectation that companies who adopt QbD, together with a quality system as described in the ICH Q10 guideline, Pharmaceutical Quality System will achieve a "desired state" of pharmaceutical manufacturing.5 These companies can expect a significant payback in reduced risks to customers and therefore to the business itself, as well as in significantly reduced risks of costly deviation investigations or rejects and consequent enforcement actions as a result of the FDA's commitment to science-based regulation and risk-based enforcement.

The technology platform needed for QbD and its associated process improvement initiatives must allow immediate user access to all the process development and manufacturing data sources and data types, so that their value can be leveraged together with data from newer (PAT) instruments. The data must be available on-demand in the same working environment with the analytics, visualization, and reporting capabilities that allow exploration of cause-and-effect relationships by collaborative multidisciplinary teams of process development, manufacturing, and quality users that work across geographic locations.

Different types of data must be easily accessible in a way that automatically accounts for their different formats, naming conventions, and their intra- and inter-batch genealogies. The data access method must let users move directly into identifying and understanding cause-and-effect relationships between critical process parameters and critical quality attributes without spending excessive amounts of time on manual programming tasks and manually collecting and reconciling data. This is the modern replacement for what is so often the spreadsheet madness that occurs today when things go wrong and the process needs to get back on track under crisis conditions.


Quality by Design can rise on the priority list only when organizations understand the business benefits it enables and have a full picture of what is required in terms of time, monetary, and resource investments. Detailed research and presentation of the regulatory and cost benefits enabled by process understanding that leads to reductions in process risks and variability will help more companies get on board to prioritize QbD ahead of other initiatives and demonstrate ROI.

Justin Neway, PhD, is the executive vice president and chief science officer at Aegis Analytical Corporation, Lafayette, CO, 303.625.2101,


1. Juran JM. Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. New York: Free Press. 1992. p. 1–2.

2. US Food and Drug Administration. Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. Pharmaceutical cGMPs. Rockville, MD; 2004 Sept. p. 1–21.

3. Aegis Analytical and AMR Research. Survey on Quality by Design. Boston: AMR Research; 2007 Sept–Oct.

4. Neway J. How new technologies can improve compliance in pharmaceutical and biotech manufacturing. World Batch Forum; 2003. Woodcliff Lake, NJ.

5. International Conference on Harmonization. Q10, Pharmaceutical Quality System. Geneva, Switzerland, 2007.

6. Burrill S. Biotech 2003: Revaluation and Restructuring. San Francisco: Burrill & Company. 2003. p. 1-357.

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