20 Questions
Pharmaceutical Quality by Design emphasizes the importance of product and process understanding, control, and risk management.
True
The concept of Quality by Design was first developed by Dr. Joseph M. Juran.
True
The US Food and Drug Administration (FDA) discourages the use of risk-based approaches in drug product development.
False
ICH Q8 (R2), ICH Q9, and ICH Q10 are documents issued to provide high-level directions for pharmaceutical Quality by Design.
True
Despite recent publications, there is no confusion among industry scientists, academicians, and regulators about the implementation details of pharmaceutical Quality by Design.
False
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
True or false: QbD elements do not include the identification of critical material attributes (CMAs) as part of product design and understanding.
False
True or false: Understanding Pharmaceutical Quality by Design (QbD) does not involve process capability and continual improvement as one of its elements.
False
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).
False
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).
False
What are some major issues contributing to the poor quality of drug products?
Variable starting materials, lack of manufacturing process automation and control, and improper understanding of product and process parameters.
When was the concept of Quality by Design (QbD) first adopted by the pharmaceutical industry?
2004
Who formulated the concept of Quality by Design (QbD) in the early 1970s?
J.M. Juran
What newer quality trend was established by the USFDA in 2005?
Quality Systems Approach to Pharmaceutical CGMP Regulations.
What are the sources of variability in drug product quality as shown in Fig. 1?
Highly variable end product, packaging variability, process variability, excipient variability, and API variability.
What are the challenges faced by the pharmaceutical industry in delivering quality drug products?
The pharmaceutical industry has been continuously facing challenges in delivering quality drug products.
Which sectors are considered highly regulated, according to the text?
The pharmaceutical market
According to the text, what does the pharmaceutical industry provide for human use?
Quality drug products for human use to provide desired pharmacotherapeutic effects for the treatment of diverse ailments.
When was it reported that the manufacturing standards of the pharmaceutical industry lagged far behind other sectors?
September 2002
What was the little secret of the pharmaceutical industry, as reported in The Wall Street Journal?
Although pharmaceutical industry has a little secret as it invents futuristic new drugs, yet its manufacturing standards are lag far behind the potato chips and laundry soap makers.
Explore the fundamental concepts of pharmaceutical quality by design (QbD) through this review article. Understand the objectives and elements of QbD in the pharmaceutical industry.
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