Concept of Quality by Design (QbD) MCQs With Answer

Introduction: The Concept of Quality by Design (QbD) is a scientific, risk-based approach to pharmaceutical development that emphasizes designing quality into products from the start. QbD integrates principles such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), risk assessment, Design of Experiments (DoE), design space and control strategy to ensure robust manufacturing and regulatory compliance. B. Pharm students should understand process understanding, multivariate data analysis, Process Analytical Technology (PAT), lifecycle management and regulatory guidances (ICH Q8/Q9/Q10). This foundation improves product quality, reduces failures, and supports continuous improvement. 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 eliminate all variability regardless of its source
• To design a robust process that ensures predefined product quality
• To replace regulatory requirements with internal standards
• To shorten patent life

Correct Answer: To design a robust process that ensures predefined product quality

Q2. Which document provides the formal regulatory framework for QbD concepts related to pharmaceutical development?

• ICH Q3
• ICH Q8
• ICH Q11
• ICH M7

Correct Answer: ICH Q8

Q3. What does QTPP stand for and why is it important?

• Quality Target Product Profile; it defines desired product characteristics and guides development
• Quality Total Process Plan; it lists all manufacturing steps
• Quantitative Test Performance Parameter; it measures equipment capability
• Quality Transfer Procedure Plan; it manages technology transfer

Correct Answer: Quality Target Product Profile; it defines desired product characteristics and guides development

Q4. Which of the following best describes a Critical Quality Attribute (CQA)?

• A process parameter that must be tightly controlled
• An attribute that impacts product safety or efficacy and must be within limits
• A production target for yield optimization
• A marketing specification for packaging design

Correct Answer: An attribute that impacts product safety or efficacy and must be within limits

Q5. Critical Process Parameters (CPPs) are identified because they:

• Directly affect production cost
• Have no impact on CQAs
• Have a direct effect on CQAs and need control
• Are required for regulatory filings only

Correct Answer: Have a direct effect on CQAs and need control

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

• Determine the cheapest raw material source
• Systematically study factor effects and interactions on CQAs
• Replace process validation entirely
• Document routine GMP tasks

Correct Answer: Systematically study factor effects and interactions on CQAs

Q7. Which tool is commonly used for risk assessment in QbD to prioritize process parameters?

• Pareto chart
• Failure Mode and Effects Analysis (FMEA)
• Gantt chart
• Six Sigma DMAIC only

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q8. The term “design space” means:

• The physical layout of a manufacturing plant
• The multidimensional combination of input variables and process parameters that ensure quality
• The marketing plan for product launch
• The list of suppliers approved for production

Correct Answer: The multidimensional combination of input variables and process parameters that ensure quality

Q9. Which statement about the design space is correct?

• Changes within the approved design space are considered a regulatory post-approval change requiring major submission
• Operating within the design space is discouraged because it increases variability
• Movement within the approved design space is generally not considered a regulatory change
• Design space is identical to specification limits

Correct Answer: Movement within the approved design space is generally not considered a regulatory change

Q10. Process Analytical Technology (PAT) supports QbD by:

• Providing real-time or near real-time measurements to monitor and control processes
• Eliminating the need for any laboratory testing
• Replacing DoE studies
• Serving only for documentation purposes

Correct Answer: Providing real-time or near real-time measurements to monitor and control processes

Q11. Which of the following is NOT a benefit of implementing QbD?

• Improved product robustness and consistency
• Fewer regulatory surprises and smoother inspections
• Guaranteed elimination of adverse events in patients
• Reduced batch failures and lifecycle costs

Correct Answer: Guaranteed elimination of adverse events in patients

Q12. Multivariate data analysis in QbD is useful because it:

• Analyzes one variable at a time
• Accounts for interactions among multiple factors simultaneously
• Is applicable only to clinical data
• Is used exclusively for packaging studies

Correct Answer: Accounts for interactions among multiple factors simultaneously

Q13. Which experimental design is most appropriate when screening a large number of factors to identify the most influential ones?

• Full factorial design with many replicates
• Plackett-Burman or fractional factorial design
• Randomized complete block design only
• Simple one-factor-at-a-time approach

Correct Answer: Plackett-Burman or fractional factorial design

Q14. Robustness testing in QbD aims to:

• Determine the most expensive raw material
• Evaluate the effect of small, deliberate variations to ensure consistent quality
• Eliminate the need for specifications
• Maximize process variability

Correct Answer: Evaluate the effect of small, deliberate variations to ensure consistent quality

Q15. Control strategy in QbD includes which of the following elements?

• Specifications, in-process controls, monitoring methods, and corrective actions
• Only final product testing
• Marketing and distribution plans
• Patent filing dates

Correct Answer: Specifications, in-process controls, monitoring methods, and corrective actions

Q16. Which ICH guidance focuses on quality risk management principles that support QbD?

• ICH Q5
• ICH Q9
• ICH Q7
• ICH Q12

Correct Answer: ICH Q9

Q17. In QbD, lifecycle management refers to:

• Managing the product only during clinical trials
• Continuous monitoring and improvement from development through commercial production
• Only post-approval change control
• Designing packaging aesthetics

Correct Answer: Continuous monitoring and improvement from development through commercial production

Q18. Which of the following best describes a Control Strategy element that can prevent a CQA excursion?

• Robust raw material supplier audits only
• In-process monitoring with real-time release using PAT
• Marketing surveillance
• Reducing batch size to minimize risk

Correct Answer: In-process monitoring with real-time release using PAT

Q19. A high Risk Priority Number (RPN) in FMEA indicates:

• A low severity and low likelihood issue
• A process or parameter needing urgent mitigation due to severity, occurrence, or detectability concerns
• An automatically acceptable process
• A marketing opportunity

Correct Answer: A process or parameter needing urgent mitigation due to severity, occurrence, or detectability concerns

Q20. Which statistical tool helps visualize relationships and reduce dimensionality in QbD datasets?

• Principal Component Analysis (PCA)
• T-test only
• Kaplan-Meier plot
• ANOVA cannot be used for this purpose

Correct Answer: Principal Component Analysis (PCA)

Q21. During scale-up, QbD principles require you to:

• Ignore small deviations because large-scale equipment is different
• Use process understanding, modeling and scale-down models to maintain CQAs
• Change CQAs arbitrarily to fit production
• Avoid any experiments at pilot scale

Correct Answer: Use process understanding, modeling and scale-down models to maintain CQAs

Q22. Which of the following is an example of a CQA for an oral solid dosage form?

• Tablet color only
• Assay/potency, dissolution, content uniformity, and impurity levels
• Shipping route for distribution
• Company logo on packaging

Correct Answer: Assay/potency, dissolution, content uniformity, and impurity levels

Q23. Implementation of QbD may affect regulatory submissions by:

• Eliminating the need for any regulatory interaction
• Providing scientific justification for proposed design space and control strategies, potentially simplifying post-approval changes
• Mandating that all manufacturing details be kept confidential
• Requiring only final product testing data

Correct Answer: Providing scientific justification for proposed design space and control strategies, potentially simplifying post-approval changes

Q24. Which approach helps ensure raw material variability is addressed under QbD?

• Ignoring supplier variability unless failures occur
• Establishing critical material attributes (CMAs) and appropriate acceptance criteria and controls
• Changing suppliers frequently to reduce dependence
• Only conducting final product testing

Correct Answer: Establishing critical material attributes (CMAs) and appropriate acceptance criteria and controls

Q25. Which of the following best describes “operational space” in QbD context?

• A non-scientific term for marketing boundaries
• A subset within the design space where routine manufacturing is performed with optimized control strategy
• The legal area of a manufacturing facility
• Only the maximum allowable limits for specifications

Correct Answer: A subset within the design space where routine manufacturing is performed with optimized control strategy

Q26. What role does method validation play in a QbD paradigm?

• None; QbD removes the need for analytical methods
• Ensures analytical methods are suitable, robust and aligned with control strategy
• Is only required for clinical assays
• Is replaced by in-process visual checks

Correct Answer: Ensures analytical methods are suitable, robust and aligned with control strategy

Q27. Which of the following is an appropriate example of using DoE to establish design space?

• Running single unplanned batches and averaging results
• Systematic factorial experiments to map factor effects and interactions and define safe-operating limits
• Only performing confirmation runs without design experiments
• Choosing factor ranges arbitrarily without experiments

Correct Answer: Systematic factorial experiments to map factor effects and interactions and define safe-operating limits

Q28. In QbD, “continuous improvement” means:

• One-time optimization during development only
• Ongoing monitoring, learning from manufacturing data and refining control strategies over product lifecycle
• Changing product formulation frequently for commercial reasons
• Improving only packaging after launch

Correct Answer: Ongoing monitoring, learning from manufacturing data and refining control strategies over product lifecycle

Q29. A successful QbD implementation requires cross-functional collaboration including:

• Only R&D scientists
• R&D, manufacturing, quality assurance, regulatory affairs, and supply chain
• Only marketing and sales teams
• External auditors exclusively

Correct Answer: R&D, manufacturing, quality assurance, regulatory affairs, and supply chain

Q30. Which statement reflects a common challenge in adopting QbD in industry?

• Immediate elimination of all regulatory inspections
• Requirement for initial investment in expertise, tools (PAT, DoE software) and cultural change
• Inability to ever change process parameters after approval
• Guaranteed faster time-to-market without additional work

Correct Answer: Requirement for initial investment in expertise, tools (PAT, DoE software) and cultural change

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