Quality by Design (QbD) is a systematic approach to pharmaceutical development and manufacturing that emphasizes designing quality into a product from the beginning. It focuses on understanding and controlling manufacturing processes to ensure consistent product quality and compliance with regulatory requirements. QbD is guided by frameworks provided by the International Council for Harmonization (ICH) and regulatory bodies like the FDA and EMA.
Key Principles of QbD
- Define Quality Target Product Profile (QTPP)
- Identify Critical Quality Attributes (CQAs)
- Define Critical Process Parameters (CPPs)
- Perform Risk Assessment
- Conduct Experimental Design (DOE)
- Perform Modeling and Analysis
- Establish Design Space
- Control Strategy
Benefits of QbD
- Improved understanding of the product and processes.
- Greater assurance of product quality.
- Reduced regulatory burden through streamlined approvals.
- Enhanced manufacturing efficiency and reduced costs.
- Facilitates compliance with Good Manufacturing Practices (GMP).
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