Can you provide an example of using the QbD approach in product formulation or process development?

Question

Accepted Answer

Qbd approach involves designing and developing a formulation and process based on quality attributes and risk assessment.

Qbd stands for Quality by Design
It involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs)
Risk assessment is done to identify potential sources of variability and their impact on CQAs
Formulation and process are then designed and developed to ensure consistent quality
Example: Qbd approach for tablet formulation may involve identifying CQAs such as dissolution rate and content uniformity, and CPPs such as compression force and blending time
The formulation and process are then optimized to ensure consistent CQAs and minimize variability

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