QbD concepts and terminology MCQs With Answer

QbD concepts and terminology MCQs With Answer

This quiz collection is designed for M.Pharm students focusing on Quality by Design (QbD) principles in pharmaceutical manufacturing. The questions emphasize core terminology, risk assessment tools, and regulatory concepts that underpin a systematic, science- and risk-based approach to product and process development. Each item targets practical understanding — linking QTPP, CQAs, CPPs, CMAs, design space, control strategies, PAT, DOE and lifecycle management — to real-world decision making and regulatory expectations. Use these MCQs to test knowledge, prepare for exams, or reinforce classroom learning; each question includes the correct answer so you can quickly identify gaps and focus further study on critical QbD elements.

Q1. What is the most accurate single-sentence definition of Quality by Design (QbD)?

• An approach that emphasizes 100% end-product testing to ensure quality
• A systematic development process that begins with predefined objectives and emphasizes product and process understanding and process control
• A regulatory framework that mandates specific equipment and facilities for manufacturing
• A labeling standard that specifies packaging and storage conditions

Correct Answer: A systematic development process that begins with predefined objectives and emphasizes product and process understanding and process control

Q2. What does QTPP stand for in QbD terminology?

• Quality Target Product Profile
• Qualified Technical Production Plan
• Quantitative Test Procedure Parameters
• Quality and Technical Performance Protocol

Correct Answer: Quality Target Product Profile

Q3. Which of the following best defines a Critical Quality Attribute (CQA)?

• A manufacturing parameter that must be measured daily
• A physical, chemical, biological or microbiological property that should be within an appropriate limit to ensure product quality
• A regulatory filing that lists allowed impurities
• A document describing packaging specifications

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

Q4. Critical Process Parameters (CPPs) are best described as:

• Process variables whose variability has an impact on a CQA and therefore should be monitored or controlled
• Only those parameters that are controlled by computer systems
• Parameters that are irrelevant to product quality but important for cost reduction
• Parameters that are defined exclusively during routine commercial production

Correct Answer: Process variables whose variability has an impact on a CQA and therefore should be monitored or controlled

Q5. In QbD, what does CMA refer to?

• Critical Manufacturing Assessment
• Critical Material Attributes
• Controlled Method Analysis
• Corrective Maintenance Actions

Correct Answer: Critical Material Attributes

Q6. How is “design space” defined under QbD principles?

• A single-valued set point for each process parameter
• A multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality
• The physical area in the plant where experimental work is performed
• A regulatory blacklist of unacceptable process conditions

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

Q7. Which element is typically NOT part of a control strategy?

• Specification limits for CQAs
• Monitoring and measurement systems including PAT
• Procedures for corrective actions
• Marketing plan for product launch

Correct Answer: Marketing plan for product launch

Q8. Process Analytical Technology (PAT) is primarily used to:

• Replace GMP requirements with automated manufacturing
• Provide timely measurements of critical quality and performance attributes for process understanding and control
• Eliminate the need for stability studies
• Conduct only preclinical analytics

Correct Answer: Provide timely measurements of critical quality and performance attributes for process understanding and control

Q9. Which sequence best represents the QbD lifecycle approach?

• Regulatory filing → Batch production → Development → Continuous improvement
• Development → Establishment of control strategy → Commercial manufacturing → Continual improvement and knowledge management
• Commercial manufacturing → Clinical trials → Stability testing → Development
• Design space definition → Immediate regulatory approval → No further changes allowed

Correct Answer: Development → Establishment of control strategy → Commercial manufacturing → Continual improvement and knowledge management

Q10. Which risk assessment tool is commonly used in QbD to identify and rank potential failure modes?

• FMEA (Failure Mode and Effects Analysis)
• ANOVA (Analysis of Variance)
• Pareto Chart exclusively
• Product labeling checklist

Correct Answer: FMEA (Failure Mode and Effects Analysis)

Q11. The primary quantitative output from a traditional FMEA is:

• Design space coordinates
• Risk Priority Number (RPN)
• Batch release certificate
• Process capability index (Cpk)

Correct Answer: Risk Priority Number (RPN)

Q12. Regulatory implication of operating within an approved design space is that:

• Any change within the design space requires a prior supplement filing
• Movement within the design space is not considered a change and normally does not require regulatory post-approval submission
• Operations are limited to a single fixed set point only
• Product must be re-tested after every batch

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

Q13. In the context of QbD, Design of Experiments (DoE) is primarily used to:

• Randomly change process parameters during routine manufacture
• Systematically study the relationship between multiple factors and CQAs to identify critical parameters and interactions
• Replace all analytical testing
• Document cleaning validation only

Correct Answer: Systematically study the relationship between multiple factors and CQAs to identify critical parameters and interactions

Q14. An Ishikawa (fishbone) diagram is most useful for:

• Graphically representing root causes contributing to a quality problem
• Measuring tablet dissolution rates
• Calculating the RPN in FMEA
• Specifying packaging sizes

Correct Answer: Graphically representing root causes contributing to a quality problem

Q15. Identification of CPPs is best achieved by integrating:

• Only historical batch release data without experiments
• Risk assessment, prior knowledge, and DoE results
• Marketing requirements and sales forecasts
• Only supplier quality agreements

Correct Answer: Risk assessment, prior knowledge, and DoE results

Q16. Which item would typically NOT be considered part of a pharmaceutical control strategy?

• In-process controls and monitoring
• Specifications for raw materials and intermediates
• Procedures for corrective and preventive actions (CAPA)
• Advertising copy for patient leaflets

Correct Answer: Advertising copy for patient leaflets

Q17. In QbD terminology, “robustness” of a process refers to:

• The ability of the process to produce quality product consistently despite small deliberate variations in parameters
• The capacity of the plant to run 24/7
• The process having no variability under any condition
• The ability to market product in multiple countries

Correct Answer: The ability of the process to produce quality product consistently despite small deliberate variations in parameters

Q18. What does the acronym MODR stand for in the context of QbD?

• Maximum Operational Deviation Range
• Manufacturing Operational Design Region
• Manufacturing Official Documentation Record
• Minimum Operational Development Requirement

Correct Answer: Manufacturing Operational Design Region

Q19. Which of the following is least likely to be classified as a Critical Quality Attribute (CQA) for a solid oral dosage form?

• Assay (potency) of active pharmaceutical ingredient
• Dissolution profile
• Tablet mass uniformity
• Marketing slogan printed on the outer carton

Correct Answer: Marketing slogan printed on the outer carton

Q20. The primary ICH guidelines that collectively support QbD implementation are:

• ICH Q1, Q2 and Q3
• ICH Q8, Q9 and Q10
• ICH M4Q, M4S and M4E
• ICH E6, E7 and E8

Correct Answer: ICH Q8, Q9 and Q10

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