White Paper: Quality By Design: The Automated Pharmaceutical Assay

By Dale VonBehren, SOTAX Corporation

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.

Validation remains very much the cornerstone in method development. We focus on traditional method attributes while not using our knowledge of the dosage form to develop efficient approaches to drug extraction. In the Stability and Quality Assurance laboratories, notebook review still serves as a defense against mix ups, transcription and calculation errors. This is the world we work in today compared to the aspiration presented by the FDA with respect to the pharmaceutical assay.