Slogging Toward Quality by Design
This article was originally published in The Gold Sheet
Executive Summary
Ten years into FDA’s quality initiative, CDER Director Janet Woodcock acknowledges continued resistance to investing in QbD as a way of preventing quality problems in commercial manufacturing. Yet others in FDA and industry see adoption of the science- and risk-based approach spreading, even though manufacturers are often reluctant to disclose how much money it’s saving them.
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