Quality by Design (QbD) for generic drugs


It is a systemic approach for ensuring quality of pharmaceuticals with predefined objectives. The focus of this concept is that quality should be built into product with understanding of the product and the process by which its manufactured along with knowledge of risk involved in manufacturing it and how severe those risks can be, while quality by design (Qbd) have been used to advance product and process quality in industry, this has been adapted by the Us Food and Drug Administration.


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