What is quality by design and explain with one case study.

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Quality by design is a systematic approach to product development that focuses on understanding and controlling the variables that affect product quality.

Quality by design involves identifying critical quality attributes and designing the product and manufacturing process to meet those attributes.
It emphasizes the use of scientific principles, risk assessment, and statistical tools to ensure quality throughout the product lifecycle.
One case study is the development of a new drug formulation, where quality by design was used to optimize the formulation and manufacturing process to ensure consistent drug release and efficacy.
Another example is the design of a medical device, where quality by design was employed to identify and control critical parameters to ensure the device's safety and performance.

What is quality by design and explain with one case study.

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