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Quality by Design -- Experimental strategies for implementing Quality by Design

April 28, 2017 By Ronald D. Snee, PhD
Tag: FDA , QBD

Much has been learned about the use of Quality by Design (QbD) since it was proposed by the FDA and ICH (2005) . While the benefits of the approach are generally acknowledged, its implementation has been slower than expected.



Resistance is to be expected when any new approach is brought forward. Common concerns are: "This is new and different - will it work?" "I don’t understand the pieces and how they fit together." "I’m afraid that it will take too long and be too costly." "We don’t have the time to do it."

Previous articles have discussed the reasons for resistance (Snee, et al 2008) and the critical elements of QbD and how they fit together (Snee 2009 a,b). Central to QbD is experimentation and how to be effective in doing experimental work. Strategy for experimentation is addressed here, including a roadmap for the sequence and linkage of the tools. Experience has shown that this approach speeds up the data collection process and helps assure that no critical variables are overlooked.

A Disciplined, Systema tic Approach is Needed

The first issue in developing any experimental strategy is to ensure that the critical elements are in place at the strategic, managerial, and operational levels of work. At the strategic level, our experimental approach needs to:
• Develop process understanding.
• Focus on sources of variation - the sources of risk (Hubert,
et al 2008).
• Identify the critical Xs - the major sources of variation
(Pareto principle).
• Ensure that the strategy matches the experimental environment.



At the managerial level, we need methods to guide the work and the tools used. This is accomplished by developing roadmaps for how the various pieces of experimental work fit together, including the sequencing and linkage of the tools.



Operational work involves data collection methods including the experimental designs (DOE) used, process modeling approaches and tools, graphics, and software. Since all of these activities may be new to many, opportunities should be available to develop the needed skills. The critical elements
of the approach are shown in Figure 1 and discussed in the following section.

Next Update: May.29th

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