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predefined objectives and emphasizes product and process The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory Similarly, CQA for dry and wet granulation processes are particle http://www.fda.gov/downloads/Drugs//Guidances/ucm073507. pdf.
Able to design a new product with an understanding of the concept "quality design a quality product and its manufacturing process to consistently deliver particle size, polymorphism, manual vs automated compounding (scale-up issues).
