pharma4u

Quality by Design (QbD) is a modern, scientific approach that formalizes product design, automates manual testing, and streamlines troubleshooting with an aim of improving quality of process and product. While Quality by Design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U.S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs in year 2011. Quality by design incorporates modern tools to preemptively control variation. These tools and methods begin by measuring and understanding the variation that exists by using historical data, testing, and modeling to help forecast, analyze, and eliminate the deleterious effects of variation using standard statistical techniques. QbD reduces manufacturing cost, product rejection ratio and thereby increases efficiency and opportunities for industry & regulators. Process control consists of three basic activities: 1) evaluate the actual performance of the process, 2) Compare actual performance with goals and 3) Take action on the difference. Quality by design increases scientific understanding of critical process and product attributes and ensures that the process and product meets its intended performance requirements throughout the product and process lifecycle. 

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