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Quality by Design: Next Steps to Realize Opportunities? - page 31 / 37

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QbD Questions (Contd.)

What are/should be the regulatory benefits of QbD?

Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance

Risk-based regulatory approaches recognize

the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance and  

the capability of process control strategies to prevent or mitigate the risk of producing a poor quality product

Example: Customized SUPAC [SUPAC –C]

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