Application of QbD in product development MCQs With Answer

Application of QbD in product development MCQs With Answer—Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical product development that emphasizes understanding formulation, process, and control strategy to ensure consistent pharmaceutical quality. For B.Pharm students, mastering QbD concepts such as Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), Design of Experiments (DoE), design space, risk assessment, PAT and regulatory guidelines (ICH Q8/Q9/Q10) is essential for modern product development and lifecycle management. These MCQs focus on practical applications, analytical considerations, and regulatory expectations to deepen your conceptual and applied knowledge. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which of the following best defines Quality by Design (QbD) in pharmaceutical product development?

• A regulatory shortcut to avoid clinical trials
• An empirical approach relying solely on end-product testing
• A systematic, science- and risk-based approach to design product and process to ensure predefined quality
• A marketing strategy to improve product sales

Correct Answer: A systematic, science- and risk-based approach to design product and process to ensure predefined quality

Q2. What is a Critical Quality Attribute (CQA)?

• A manufacturing equipment specification
• A property of a drug product that must be within limits to ensure desired product quality
• An administrative record of production
• A marketing parameter related to patient preference

Correct Answer: A property of a drug product that must be within limits to ensure desired product quality

Q3. Which element identifies material attributes that impact CQAs?

• Control Strategy
• Design Space
• Critical Material Attributes (CMAs)
• Process Validation Plan

Correct Answer: Critical Material Attributes (CMAs)

Q4. In QbD, what does CPP stand for and why is it important?

• Critical Process Parameter; it affects CQAs and must be controlled
• Clinical Pharmacology Plan; it defines clinical endpoints
• Controlled Packaging Protocol; it ensures package aesthetics
• Cost-per-Product; it guides pricing decisions

Correct Answer: Critical Process Parameter; it affects CQAs and must be controlled

Q5. Which tool is commonly used in QbD for multivariate experimental planning?

• Design of Experiments (DoE)
• Single-variable trial-and-error
• Visual inspection checklist
• Random sampling without plan

Correct Answer: Design of Experiments (DoE)

Q6. What is the ‘design space’ in QbD terminology?

• The physical facility where product is designed
• Combination of input variables and process parameters proven to provide quality
• A marketing region for product launch
• A manufacturing schedule

Correct Answer: Combination of input variables and process parameters proven to provide quality

Q7. Which ICH guideline primarily covers pharmaceutical development and QbD concepts?

• ICH Q1A
• ICH Q8
• ICH E6
• ICH M7

Correct Answer: ICH Q8

Q8. Failure Mode and Effects Analysis (FMEA) in QbD is used for which purpose?

• Estimating product market share
• Systematic risk assessment to prioritize potential failures and controls
• Designing packaging artwork
• Determining clinical dosing

Correct Answer: Systematic risk assessment to prioritize potential failures and controls

Q9. What role does Process Analytical Technology (PAT) play in QbD?

• Only used for final product labeling
• Real-time monitoring and control to ensure quality during manufacturing
• Replaces the need for quality assurance personnel
• Ensures marketing compliance

Correct Answer: Real-time monitoring and control to ensure quality during manufacturing

Q10. Which of the following best describes robustness testing in QbD?

• Testing only the active pharmaceutical ingredient
• Evaluating the effect of small deliberate variations in process parameters on CQAs
• Testing consumer preference
• Measuring packaging durability in shipping

Correct Answer: Evaluating the effect of small deliberate variations in process parameters on CQAs

Q11. Which statistical design is typically used for screening critical factors in early QbD studies?

• Full factorial or fractional factorial design
• ANOVA without design
• Descriptive statistics only
• Simple random sampling

Correct Answer: Full factorial or fractional factorial design

Q12. What is the purpose of establishing a control strategy in QbD?

• To reduce documentation
• To ensure that the product remains within the design space and meets CQAs
• To define marketing channels
• To schedule employee shifts

Correct Answer: To ensure that the product remains within the design space and meets CQAs

Q13. Which risk assessment tool is useful for identifying root causes in QbD investigations?

• Ishikawa (fishbone) diagram
• Brand positioning map
• Clinical outcome chart
• Supply chain ledger

Correct Answer: Ishikawa (fishbone) diagram

Q14. How does QbD impact regulatory submissions?

• QbD data can enable greater regulatory flexibility and potential post-approval changes within design space
• Regulators ignore QbD information
• QbD increases the number of required clinical trials
• QbD eliminates the need for stability studies

Correct Answer: QbD data can enable greater regulatory flexibility and potential post-approval changes within design space

Q15. In DoE optimization, what is a response surface?

• A plot of marketing responses to sales
• A mathematical model or plot describing how responses (CQAs) change with input factors
• A list of raw material suppliers
• A physical map of the manufacturing plant

Correct Answer: A mathematical model or plot describing how responses (CQAs) change with input factors

Q16. Which of the following is an example of a CQA for a tablet dosage form?

• Tablet color in marketing photos only
• Assay/potency of the active pharmaceutical ingredient
• Supplier’s location
• Employee training records

Correct Answer: Assay/potency of the active pharmaceutical ingredient

Q17. What is the relationship between CQAs and patient safety/effectiveness?

• CQAs are unrelated to clinical performance
• CQAs are directly linked to safety and efficacy; failing CQAs may compromise patient outcomes
• CQAs only affect packaging aesthetics
• CQAs only concern cost reduction

Correct Answer: CQAs are directly linked to safety and efficacy; failing CQAs may compromise patient outcomes

Q18. Which activity is part of the QbD lifecycle approach?

• Continuous improvement and monitoring throughout product life
• One-time approval and no further evaluation
• Only marketing feedback analysis
• Discarding process understanding after approval

Correct Answer: Continuous improvement and monitoring throughout product life

Q19. During formulation development, which QbD concept helps link material attributes to product performance?

• Critical Material Attributes (CMAs) and risk assessment mapping to CQAs
• Only final product testing without mapping
• Advertising testing
• Sales data mining

Correct Answer: Critical Material Attributes (CMAs) and risk assessment mapping to CQAs

Q20. What advantage does defining a design space offer to manufacturers?

• Allows operations flexibility within proven ranges without prior regulatory approval for certain changes
• Makes product development more secretive
• Eliminates the need for any monitoring
• Guarantees zero product failures

Correct Answer: Allows operations flexibility within proven ranges without prior regulatory approval for certain changes

Q21. In analytical method development under QbD, what is Analytical Quality by Design (AQbD)?

• A marketing term for analytical instruments
• A systematic approach to develop robust analytical methods using risk assessment and DoE
• A method to avoid validation
• An inventory system for reagents

Correct Answer: A systematic approach to develop robust analytical methods using risk assessment and DoE

Q22. Which parameter is typically NOT considered a CQA for injectable solutions?

• Particulate matter above limits
• pH outside specified range
• Color of the plastic shipping crate
• Assay/potency deviations

Correct Answer: Color of the plastic shipping crate

Q23. What is the main purpose of performing a risk assessment at the start of product development?

• To decide the sales price
• To identify and prioritize potential factors that may impact CQAs and guide experiments
• To create marketing campaigns
• To allocate office space

Correct Answer: To identify and prioritize potential factors that may impact CQAs and guide experiments

Q24. Which design is best for optimizing two or three critical factors when curvature is expected?

• Full factorial without center points
• Response Surface Methodology (e.g., Central Composite Design)
• Simple linear regression
• Descriptive case study

Correct Answer: Response Surface Methodology (e.g., Central Composite Design)

Q25. How does QbD influence scale-up from lab to commercial production?

• By providing science-based scale-up criteria and understanding of CPPs and CMAs to maintain CQAs
• By requiring identical equipment at all scales
• By eliminating the need for pilot batches
• By focusing only on packaging changes

Correct Answer: By providing science-based scale-up criteria and understanding of CPPs and CMAs to maintain CQAs

Q26. Which metric is commonly used in FMEA to prioritize risks?

• Return on investment (ROI)
• Risk Priority Number (RPN) combining severity, occurrence, and detectability
• Employee satisfaction score
• Market share percentage

Correct Answer: Risk Priority Number (RPN) combining severity, occurrence, and detectability

Q27. When developing a control strategy, which of the following is essential?

• Identification of monitoring and control elements tied to CQAs and CPPs
• Only external audits without internal monitoring
• Ignoring analytical method variability
• Relying exclusively on final product inspection

Correct Answer: Identification of monitoring and control elements tied to CQAs and CPPs

Q28. Which of the following best describes a robustness study for an analytical method under AQbD?

• Studying the influence of deliberate small variations in method parameters on method performance
• Validating only once without any variation
• Only testing different brands of reagents for cost
• Testing method only at extreme conditions outside intended use

Correct Answer: Studying the influence of deliberate small variations in method parameters on method performance

Q29. Which ICH guideline focuses on quality risk management applicable to QbD?

• ICH Q8
• ICH Q9
• ICH Q10
• ICH Q1

Correct Answer: ICH Q9

Q30. Which statement about continuous manufacturing in the context of QbD is true?

• Continuous manufacturing cannot be supported by QbD principles
• QbD principles such as PAT and real-time control facilitate reliable continuous manufacturing
• Continuous manufacturing always eliminates the need for process monitoring
• QbD only applies to batch processes, not continuous

Correct Answer: QbD principles such as PAT and real-time control facilitate reliable continuous manufacturing

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