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Quality By Design: The Automated Pharmaceutical Assay

Published 03 May 2011 | By Sotax

Who can argue against the concept of Quality by Design (QbD) in the pharmaceutical industry? We should always strive to improve our systems and the way tasks are accomplished. The pharmaceutical industry should be no exception. One lofty definition of QbD according to the FDA is “A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight.” Coming back down to earth for a moment it is logical to assume that Chemistry, Manufacturing, and Controls (CMC) should be at the core of this initiative. In the pharmaceutical laboratory, QbD challenges our understanding of the product. It requires more robust and rugged methods that can provide more information and be efficiently executed.

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Quality By Design: The Automated Pharmaceutical Assay