Quality by Design (QbD) – definition, overview and elements MCQs With Answer

Quality by Design (QbD) is a systematic, science‑based approach to pharmaceutical development that emphasizes understanding processes and controlling variability to ensure product quality. Key concepts include critical quality attributes (CQAs), critical process parameters (CPPs), design space, control strategy, PAT and quality risk management. QbD integrates experimental design, risk assessment and lifecycle management to develop robust formulations and scalable manufacturing. For B. Pharm students, mastering QbD builds skills in DoE, multivariate analysis, regulatory expectations (ICH Q8/Q9/Q10), and continual improvement of drug products. This foundation supports efficient development, regulatory flexibility and consistent patient safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary goal of Quality by Design (QbD) in pharmaceutical development?

• To minimize documentation required for regulatory submission
• To ensure consistent product quality through understanding and control of processes
• To replace all conventional validation activities with simulations
• To increase production speed regardless of variability

Correct Answer: To ensure consistent product quality through understanding and control of processes

Q2. Which of the following best defines a Critical Quality Attribute (CQA)?

• A process parameter monitored only during scale-up
• A physical, chemical, biological or microbiological property that should be within limits to ensure product quality
• An equipment maintenance schedule
• A regulatory filing requirement unrelated to product safety

Correct Answer: A physical, chemical, biological or microbiological property that should be within limits to ensure product quality

Q3. Critical Process Parameters (CPPs) are important because they:

• Determine the cost of raw materials
• Directly affect CQAs and must be controlled to maintain product quality
• Are only relevant during clinical trials
• Are synonyms for CQAs

Correct Answer: Directly affect CQAs and must be controlled to maintain product quality

Q4. The term “design space” in QbD means:

• The physical layout of the manufacturing plant
• The range of input variables and process parameters that produce acceptable quality
• A fixed set of process conditions mandated by regulators
• The color and shape design of product packaging

Correct Answer: The range of input variables and process parameters that produce acceptable quality

Q5. Which ICH guidance primarily addresses pharmaceutical development and supports QbD principles?

• ICH Q2
• ICH Q8
• ICH M4
• ICH S7

Correct Answer: ICH Q8

Q6. Design of Experiments (DoE) in QbD is used to:

• Randomly choose formulation ingredients
• Systematically study the effect of multiple factors on responses to identify robust settings
• Document batch records
• Replace all analytical methods

Correct Answer: Systematically study the effect of multiple factors on responses to identify robust settings

Q7. Process Analytical Technology (PAT) contributes to QbD by:

• Eliminating the need for process control
• Providing real-time measurement and control of critical quality and process parameters
• Serving only as a post-production quality check
• Replacing stability studies

Correct Answer: Providing real-time measurement and control of critical quality and process parameters

Q8. Quality Risk Management (QRM) in QbD primarily involves:

• Financial risk assessment for market launch
• Systematic assessment, control and review of risks to product quality
• Marketing risk analysis
• Employee performance evaluations

Correct Answer: Systematic assessment, control and review of risks to product quality

Q9. Which tool is commonly used for risk assessment in QbD to prioritize factors affecting quality?

• FMEA (Failure Mode and Effects Analysis)
• Pareto chart for financials
• Thermal gravimetric analysis
• Colorimetry

Correct Answer: FMEA (Failure Mode and Effects Analysis)

Q10. In a QbD approach, the control strategy is best described as:

• A schedule for marketing visits
• A planned set of controls, derived from product and process understanding, to ensure quality
• A list of possible suppliers without qualification
• A batch release checklist only

Correct Answer: A planned set of controls, derived from product and process understanding, to ensure quality

Q11. Which analytical approach helps interpret multivariate data generated during DoE and PAT studies?

• Univariate t-test only
• Principal component analysis (PCA) and multivariate data analysis
• Simple linear regression for a single factor
• Visual inspection without statistics

Correct Answer: Principal component analysis (PCA) and multivariate data analysis

Q12. Establishing a design space can provide regulatory flexibility because:

• It allows changes within the space without prior regulatory approval
• It permits any change regardless of impact
• It removes the need for GMP compliance
• It guarantees faster approval for all products

Correct Answer: It allows changes within the space without prior regulatory approval

Q13. Which element is NOT typically part of QbD implementation?

• Comprehensive product and process understanding
• Continuous improvement and lifecycle management
• Random selection of process parameters without study
• Risk assessment and control strategies

Correct Answer: Random selection of process parameters without study

Q14. During formulation development, identifying the CQA for dissolution is important because:

• Dissolution never affects bioavailability
• Dissolution can directly impact drug release and therapeutic performance
• Dissolution is only relevant for parenteral products
• It is required solely for labeling purposes

Correct Answer: Dissolution can directly impact drug release and therapeutic performance

Q15. In QbD, robustness refers to:

• The ability of a process to remain unaffected by small, deliberate changes
• The strength of packaging materials
• The potency of active pharmaceutical ingredient only
• The duration of marketing exclusivity

Correct Answer: The ability of a process to remain unaffected by small, deliberate changes

Q16. Which stage of product lifecycle is emphasized in QbD for continual assurance of quality?

• Only early development stages
• Entire lifecycle from development through commercial production and post-approval changes
• Only commercial production after approval
• Only clinical trial manufacturing

Correct Answer: Entire lifecycle from development through commercial production and post-approval changes

Q17. Which regulatory guidance focuses on pharmaceutical quality systems and complements QbD?

• ICH Q10
• ICH Q3
• ICH E6
• ICH S9

Correct Answer: ICH Q10

Q18. A successful DoE requires defining responses. Which of the following is an appropriate response in formulation DoE?

• Tablet hardness, dissolution rate and assay content
• Company logo design
• Administrative staff roster
• Number of suppliers contacted

Correct Answer: Tablet hardness, dissolution rate and assay content

Q19. When performing QbD studies, raw material quality attributes are assessed because:

• They never impact final product performance
• Variability in raw materials can lead to variability in CQAs
• Regulators do not consider raw materials
• Only packaging materials matter

Correct Answer: Variability in raw materials can lead to variability in CQAs

Q20. Multivariate control strategies are advantageous in QbD because they:

• Ignore correlations between variables
• Allow simultaneous monitoring and control of correlated CPPs to maintain CQAs
• Require no statistical expertise
• Are only theoretical and not practical

Correct Answer: Allow simultaneous monitoring and control of correlated CPPs to maintain CQAs

Q21. Which of the following is an example of a CPP in tablet manufacturing?

• Granulation binder concentration, compression force, and drying temperature
• Company mission statement
• Marketing claims on the package
• Number of employees on the production line

Correct Answer: Granulation binder concentration, compression force, and drying temperature

Q22. ICH Q9 provides guidance primarily on:

• Stability testing conditions
• Quality risk management principles and tools
• Bioequivalence study design
• Labeling requirements

Correct Answer: Quality risk management principles and tools

Q23. Which statement about a control strategy is true?

• It is only created after product launch
• It is a dynamic plan that may include in‑process controls, specifications, and PAT
• It must list every possible failure without prioritization
• It eliminates the need for batch release testing

Correct Answer: It is a dynamic plan that may include in‑process controls, specifications, and PAT

Q24. Which type of study helps determine the relationship between CPPs and CQAs?

• Literature review only
• Design of Experiments (DoE) studies
• Sales forecasting
• Visual inspection of one batch

Correct Answer: Design of Experiments (DoE) studies

Q25. A well‑defined design space helps in scale-up because it:

• Specifies equipment painting requirements
• Identifies acceptable ranges for variables that maintain product quality during scale changes
• Removes the need for operator training
• Guarantees zero batch failures

Correct Answer: Identifies acceptable ranges for variables that maintain product quality during scale changes

Q26. In QbD, what is the role of stability studies?

• They are unrelated to QbD
• They define shelf-life and help set specifications as part of lifecycle management
• They only check packaging aesthetics
• They replace DoE experiments

Correct Answer: They define shelf-life and help set specifications as part of lifecycle management

Q27. Which practice improves robustness of an analytical method within QbD?

• Ignoring method parameters during validation
• Performing method robustness studies and setting appropriate system suitability criteria
• Using a method developed for another molecule without evaluation
• Only validating for a single instrument

Correct Answer: Performing method robustness studies and setting appropriate system suitability criteria

Q28. Continuous manufacturing aligns with QbD because it:

• Increases variability compared to batch processes
• Enables better process control and real‑time quality assurance
• Is exclusively used for biologics
• Eliminates need for PAT

Correct Answer: Enables better process control and real‑time quality assurance

Q29. What is the purpose of establishing acceptance criteria in QbD studies?

• To set arbitrary limits to speed up testing
• To define scientifically justified limits for responses and CQAs based on risk and clinical relevance
• To limit the number of experiments performed
• To satisfy marketing requirements only

Correct Answer: To define scientifically justified limits for responses and CQAs based on risk and clinical relevance

Q30. Which outcome indicates successful implementation of QbD for a pharmaceutical product?

• Frequent unexplained batch failures
• Improved process understanding, fewer deviations, and consistent product quality
• Elimination of all quality control testing
• Increased regulatory queries and recalls

Correct Answer: Improved process understanding, fewer deviations, and consistent product quality

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