Quality by design(QbD) approach

Quality by Design (QbD) is a systematic approach to pharmaceutical development that focuses on predefined quality objectives. It emphasizes understanding product and process variability and designing robust manufacturing processes. QbD involves identifying critical quality attributes (CQAs), defining critical process parameters (CPPs), and conducting risk assessments to ensure consistent product quality. The goal is to build quality into the product from the outset, reducing variability and ensuring regulatory compliance.

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