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Questions and Answers
What is the main emphasis of pharmaceutical Quality by Design?
According to Dr. Juran, where should quality be designed?
What does Woodcock define as a high-quality drug product?
What does the US FDA emphasize in drug product development?
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What are the key components of pharmaceutical QbD?
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What is the primary objective of pharmaceutical quality by design (QbD)?
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Which element of QbD involves identifying critical material attributes (CMAs)?
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What are critical process parameters (CPPs) linked to in the context of QbD?
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Which tool or study is part of QbD and involves the use of risk assessment and mechanistic models?
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What does the control strategy in QbD include?
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Study Notes
Pharmaceutical Quality by Design (QbD)
- The main emphasis of pharmaceutical QbD is on building quality into the product and process during the development phase.
Quality Design Emphasis
- According to Dr. Juran, quality should be designed into the product and process.
High-Quality Drug Product Definition
- Woodcock defines a high-quality drug product as one that is safe, effective, and possesses the desired quality attributes.
US FDA Emphasis
- The US FDA emphasizes a science- and risk-based approach in drug product development.
Pharmaceutical QbD Components
- The key components of pharmaceutical QbD include:
- Target product profile (TPP)
- Critical quality attributes (CQAs)
- Critical material attributes (CMAs)
- Critical process parameters (CPPs)
Primary Objective of Pharmaceutical QbD
- The primary objective of pharmaceutical QbD is to ensure the quality of the product by designing and controlling the product and process parameters.
Critical Material Attributes (CMAs)
- The element of QbD that involves identifying critical material attributes (CMAs) is the risk assessment and material control strategy.
Critical Process Parameters (CPPs)
- Critical process parameters (CPPs) are linked to critical quality attributes (CQAs).
Risk Assessment and Mechanistic Models
- A tool or study part of QbD involves the use of risk assessment and mechanistic models, which is also known as a design space.
Control Strategy in QbD
- The control strategy in QbD includes a set of controls and supervision that ensure the product meets the desired quality attributes.
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Description
Test your knowledge about pharmaceutical quality by design (QbD) and its objectives. Learn about the key elements of QbD and its importance in pharmaceutical development.
