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Questions and Answers
Pharmaceutical Quality by Design emphasizes the importance of product and process understanding, control, and risk management.
Pharmaceutical Quality by Design emphasizes the importance of product and process understanding, control, and risk management.
True (A)
The concept of Quality by Design was first developed by Dr. Joseph M. Juran.
The concept of Quality by Design was first developed by Dr. Joseph M. Juran.
True (A)
The US Food and Drug Administration (FDA) discourages the use of risk-based approaches in drug product development.
The US Food and Drug Administration (FDA) discourages the use of risk-based approaches in drug product development.
False (B)
ICH Q8 (R2), ICH Q9, and ICH Q10 are documents issued to provide high-level directions for pharmaceutical Quality by Design.
ICH Q8 (R2), ICH Q9, and ICH Q10 are documents issued to provide high-level directions for pharmaceutical Quality by Design.
Despite recent publications, there is no confusion among industry scientists, academicians, and regulators about the implementation details of pharmaceutical Quality by Design.
Despite recent publications, there is no confusion among industry scientists, academicians, and regulators about the implementation details of pharmaceutical Quality by Design.
True or false: Pharmaceutical Quality by Design (QbD) includes a control strategy that specifies specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process.
True or false: Pharmaceutical Quality by Design (QbD) includes a control strategy that specifies specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process.
True or false: QbD elements do not include the identification of critical material attributes (CMAs) as part of product design and understanding.
True or false: QbD elements do not include the identification of critical material attributes (CMAs) as part of product design and understanding.
True or false: Understanding Pharmaceutical Quality by Design (QbD) does not involve process capability and continual improvement as one of its elements.
True or false: Understanding Pharmaceutical Quality by Design (QbD) does not involve process capability and continual improvement as one of its elements.
True or false: QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, but not process analytical technology (PAT).
True or false: QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, but not process analytical technology (PAT).
True or false: The AAPS Journal article mentioned that QbD elements do not encompass the identification of critical process parameters (CPPs) and their linkage to critical quality attributes (CQAs).
True or false: The AAPS Journal article mentioned that QbD elements do not encompass the identification of critical process parameters (CPPs) and their linkage to critical quality attributes (CQAs).
What are some major issues contributing to the poor quality of drug products?
What are some major issues contributing to the poor quality of drug products?
When was the concept of Quality by Design (QbD) first adopted by the pharmaceutical industry?
When was the concept of Quality by Design (QbD) first adopted by the pharmaceutical industry?
Who formulated the concept of Quality by Design (QbD) in the early 1970s?
Who formulated the concept of Quality by Design (QbD) in the early 1970s?
What newer quality trend was established by the USFDA in 2005?
What newer quality trend was established by the USFDA in 2005?
What are the sources of variability in drug product quality as shown in Fig. 1?
What are the sources of variability in drug product quality as shown in Fig. 1?
What are the challenges faced by the pharmaceutical industry in delivering quality drug products?
What are the challenges faced by the pharmaceutical industry in delivering quality drug products?
Which sectors are considered highly regulated, according to the text?
Which sectors are considered highly regulated, according to the text?
According to the text, what does the pharmaceutical industry provide for human use?
According to the text, what does the pharmaceutical industry provide for human use?
When was it reported that the manufacturing standards of the pharmaceutical industry lagged far behind other sectors?
When was it reported that the manufacturing standards of the pharmaceutical industry lagged far behind other sectors?
What was the little secret of the pharmaceutical industry, as reported in The Wall Street Journal?
What was the little secret of the pharmaceutical industry, as reported in The Wall Street Journal?
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