Quality by Design concepts MCQs With Answer

Introduction: Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical development that emphasizes understanding the product and manufacturing process to ensure consistent quality. For M.Pharm students, mastering QbD concepts is essential because regulators expect demonstration of product knowledge, justified control strategies, and lifecycle management. This blog presents focused multiple-choice questions with answers to reinforce core QbD topics: Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), Design of Experiments (DoE), risk assessment tools, design space, and Process Analytical Technology (PAT). Use these MCQs to deepen conceptual clarity and exam readiness.

Q1. What is the best concise definition of Quality by Design (QbD)?

• A one-time validation approach focused on finished-product testing
• An ad hoc strategy to reduce manufacturing costs
• A systematic approach to development beginning with predefined objectives and emphasizing product and process understanding and control
• A marketing-driven framework to accelerate product launch

Correct Answer: A systematic approach to development beginning with predefined objectives and emphasizing product and process understanding and control

Q2. Which ICH guidance documents form the core regulatory framework for QbD implementation?

• ICH Q1, Q2 and Q3
• ICH Q8, Q9 and Q10
• ICH M4, M7 and S7
• ICH E6, E8 and E9

Correct Answer: ICH Q8, Q9 and Q10

Q3. What does QTPP stand for in QbD terminology?

• Quality Target Product Profile (QTPP)
• Quantitative Testing Product Plan
• Quality Tested Production Procedure
• Qualified Technical Process Parameter

Correct Answer: Quality Target Product Profile (QTPP)

Q4. Which term describes a physical, chemical, biological or microbiological property that should be within an appropriate limit to ensure product quality?

• Critical Process Parameter (CPP)
• Quality Target Product Profile (QTPP)
• Critical Quality Attribute (CQA)
• Design Space

Correct Answer: Critical Quality Attribute (CQA)

Q5. Which of the following best defines a Critical Material Attribute (CMA)?

• An attribute of the final packaged product that influences market acceptance
• A material property or characteristic that impacts drug product quality and should be controlled
• A statistical parameter used in DoE screening
• A regulatory classification for excipient suppliers

Correct Answer: A material property or characteristic that impacts drug product quality and should be controlled

Q6. What is a Critical Process Parameter (CPP)?

• A process parameter whose variability has no impact on product quality
• A process parameter that must be tightly controlled because it has direct impact on CQA
• An optional manufacturing setting used for energy savings
• A parameter recorded only for batch record completeness

Correct Answer: A process parameter that must be tightly controlled because it has direct impact on CQA

Q7. What is the primary purpose of Design of Experiments (DoE) within QbD?

• To increase batch size without testing
• To generate unstructured data for later analysis
• To identify and quantify relationships between inputs (factors) and outputs (responses) and optimize settings
• To replace risk assessment completely

Correct Answer: To identify and quantify relationships between inputs (factors) and outputs (responses) and optimize settings

Q8. How does ICH Q8 define a “design space”?

• A single maximum allowable value for each process parameter
• A non-regulatory guideline for marketing strategy
• A multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality
• A fixed production schedule for regulatory filing

Correct Answer: A multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality

Q9. Which elements are typically included in a control strategy under QbD?

• Only finished-product release testing
• Raw material selection without process controls
• A combination of controls, monitoring, feedback/feedforward actions, PAT and acceptance criteria to ensure product quality
• Only personnel training records

Correct Answer: A combination of controls, monitoring, feedback/feedforward actions, PAT and acceptance criteria to ensure product quality

Q10. Which risk assessment tool explicitly prioritizes failure modes using severity, occurrence and detectability scores?

• Ishikawa (fishbone) diagram
• Pareto analysis
• Failure Modes and Effects Analysis (FMEA)
• Process mapping

Correct Answer: Failure Modes and Effects Analysis (FMEA)

Q11. What regulatory flexibility is associated with operating within a validated design space?

• Any change within design space always requires immediate regulatory submission
• Movement within the approved design space is not considered a change and generally does not require regulatory post-approval submission
• Design space only applies to analytical methods, not manufacturing
• Operating outside the design space is encouraged for optimization

Correct Answer: Movement within the approved design space is not considered a change and generally does not require regulatory post-approval submission

Q12. What is the principal goal of Process Analytical Technology (PAT) in a QbD framework?

• To delay process monitoring until batch end
• To enable real-time or near-real-time monitoring and control of critical quality attributes and process parameters
• To eliminate the need for any controls
• To provide marketing data on product appearance

Correct Answer: To enable real-time or near-real-time monitoring and control of critical quality attributes and process parameters

Q13. Why is multivariate data analysis important in QbD?

• It only reduces computational workload
• It analyzes relationships among multiple variables simultaneously, revealing true factor interactions and correlations
• It replaces all laboratory testing
• It only visualizes single-variable trends

Correct Answer: It analyzes relationships among multiple variables simultaneously, revealing true factor interactions and correlations

Q14. What does a robustness study evaluate in pharmaceutical development?

• The long-term market acceptance of the product
• The effect of small, deliberate variations in method or process parameters on product quality
• Only degradation rates under extreme conditions
• The batch-to-batch color variation for branding

Correct Answer: The effect of small, deliberate variations in method or process parameters on product quality

Q15. Which items collectively form the “knowledge space” in a QbD program?

• Marketing plans and pricing strategies only
• DoE results, risk assessments, material and process attribute data, and QTPP definitions
• Only regulatory submission documents without experimental data
• Warehouse locations and shipping schedules

Correct Answer: DoE results, risk assessments, material and process attribute data, and QTPP definitions

Q16. Which experimental design is best suited for initial screening when there are many factors?

• Full factorial design with all interactions at many levels
• Fractional factorial design
• One-factor-at-a-time (OFAT) with no replication
• Central composite design (CCD) exclusively

Correct Answer: Fractional factorial design

Q17. Central Composite Design (CCD) is most commonly used for which purpose?

• Screening dozens of factors with single runs
• Response surface methodology to model curvature and optimize factor settings
• Only for categorical factor analysis
• Exclusively for stability testing

Correct Answer: Response surface methodology to model curvature and optimize factor settings

Q18. How is criticality of a process parameter typically determined in QbD?

• By management opinion without data
• Through combined use of risk assessment and experimental evidence showing impact on CQAs
• By selecting parameters with the widest tolerances
• Only by supplier specifications

Correct Answer: Through combined use of risk assessment and experimental evidence showing impact on CQAs

Q19. What is the main aim of a lifecycle approach to pharmaceutical quality under QbD?

• To lock processes permanently after initial approval
• To continuously improve and maintain product quality through knowledge management, continual monitoring and change control over the product lifecycle
• To avoid any process improvements after approval
• To replace quality systems with ad hoc fixes

Correct Answer: To continuously improve and maintain product quality through knowledge management, continual monitoring and change control over the product lifecycle

Q20. Which of the following best describes the role of control strategy documentation in regulatory submissions?

• It is optional and not reviewed by regulators
• It documents how product quality is achieved and maintained, providing the scientific and risk-based justification for controls
• It focuses only on marketing claims
• It lists only supplier contact information

Correct Answer: It documents how product quality is achieved and maintained, providing the scientific and risk-based justification for controls

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