Unit 12: Quality by Design (QbD)
Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that integrates risk management and process understanding. It involves defining QTPP, identifying CQAs, applying DoE, and implementing a robust control strategy.
Definition
Quality by Design (QbD) is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management.
QbD ensures that quality is built into the product from the design stage rather than tested at the end. It involves defining a Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), and establishing a robust control strategy.
Key Points
ICH Q8(R2) provides QbD guidelines
Focuses on risk-based development
Uses Design of Experiments (DoE) for optimization
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