Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical development that emphasizes designing quality into products from the start. QbD integrates concepts such as critical quality attributes (CQAs), critical process parameters (CPPs), design space, control strategy, Design of Experiments (DoE), Process Analytical Technology (PAT), and risk assessment to ensure robust manufacturing and regulatory compliance. Understanding implementation steps, regulatory guidance (ICH Q8/Q9/Q10), and lifecycle management helps B. Pharm students apply QbD to formulation, scale-up, and validation. This keyword-rich overview prepares you for practical problem solving and regulatory expectations. 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 reduce documentation during manufacturing
- To design product and process knowledge to ensure predefined product quality
- To lower the cost of raw materials
- To increase production speed regardless of quality
Correct Answer: To design product and process knowledge to ensure predefined product quality
Q2. Which ICH guideline primarily describes pharmaceutical development and supports QbD principles?
- ICH Q1
- ICH Q8
- ICH Q11
- ICH M7
Correct Answer: ICH Q8
Q3. Critical Quality Attributes (CQAs) are best defined as:
- Attributes of raw materials only
- Physical, chemical, biological or microbiological properties that should be within an appropriate limit to ensure product quality
- Equipment specifications that affect yield
- Marketing specifications for packaging design
Correct Answer: Physical, chemical, biological or microbiological properties that should be within an appropriate limit to ensure product quality
Q4. Which tool is commonly used in QbD for systematic experimentation to understand the effect of factors on responses?
- Pareto chart
- Design of Experiments (DoE)
- Standard Operating Procedure (SOP)
- Batch record
Correct Answer: Design of Experiments (DoE)
Q5. A design space is defined as:
- The single set point for each process parameter
- The multidimensional combination and interaction of input variables and process parameters that assure quality
- The floor area of a production facility
- The list of suppliers for a product
Correct Answer: The multidimensional combination and interaction of input variables and process parameters that assure quality
Q6. Which is a primary purpose of risk assessment in QbD?
- To eliminate the need for validation
- To prioritize process parameters and material attributes that impact CQAs
- To replace stability studies
- To increase regulatory submissions
Correct Answer: To prioritize process parameters and material attributes that impact CQAs
Q7. Which of the following is an example of a Process Analytical Technology (PAT) tool?
- Near-Infrared Spectroscopy (NIR)
- Blender vendor catalog
- Marketing questionnaire
- Invoice tracking software
Correct Answer: Near-Infrared Spectroscopy (NIR)
Q8. Critical Process Parameters (CPPs) are:
- Process parameters that have negligible effect on product quality
- Process parameters whose variability has an impact on a CQA and therefore should be monitored or controlled
- Only related to packaging operations
- Only measured during clinical trials
Correct Answer: Process parameters whose variability has an impact on a CQA and therefore should be monitored or controlled
Q9. Which statistical concept is important when analyzing DoE results in QbD?
- p-values and interaction effects
- Company profit margins
- Advertising response rates
- Supply chain lead time
Correct Answer: p-values and interaction effects
Q10. In QbD, knowledge management refers to:
- Documenting and leveraging prior product and process knowledge to support development and lifecycle activities
- Only storing batch records in long-term archives
- Marketing data collection
- Vendor performance scoring
Correct Answer: Documenting and leveraging prior product and process knowledge to support development and lifecycle activities
Q11. What does the lifecycle approach in QbD emphasize?
- One-time development and no further changes
- Continual improvement and ongoing process understanding across development, commercialization and post-approval changes
- Only preclinical testing
- Reducing documentation after approval
Correct Answer: Continual improvement and ongoing process understanding across development, commercialization and post-approval changes
Q12. Which ICH guideline focuses on quality risk management relevant to QbD?
- ICH Q3
- ICH Q9
- ICH S7
- ICH E6
Correct Answer: ICH Q9
Q13. Which action is part of establishing a control strategy under QbD?
- Identifying monitoring approaches and acceptance criteria for CPPs and CQAs
- Selecting suppliers without qualification
- Eliminating in-process testing entirely
- Choosing the cheapest excipients only
Correct Answer: Identifying monitoring approaches and acceptance criteria for CPPs and CQAs
Q14. In DoE, a factorial design is useful because it:
- Tests each factor one at a time without interactions
- Allows simultaneous evaluation of multiple factors and their interactions
- Is only applicable to clinical trials
- Does not require statistical analysis
Correct Answer: Allows simultaneous evaluation of multiple factors and their interactions
Q15. Which is an example of an input material attribute considered in QbD?
- Tablet blister color
- API particle size distribution
- Employee shift pattern
- Company logo design
Correct Answer: API particle size distribution
Q16. Which statement about design space justification is true?
- Design space is defined solely by marketing needs
- Demonstration of design space requires scientific data and risk-based assessment
- Design space can be arbitrarily enlarged without evidence
- Design space replaces the need for specifications
Correct Answer: Demonstration of design space requires scientific data and risk-based assessment
Q17. How does QbD help during scale-up from lab to manufacturing?
- By defining critical parameters and understanding their scaling relationships to maintain CQAs
- By removing all quality testing at scale
- By ensuring every parameter remains identical numerically
- By only changing the equipment brand
Correct Answer: By defining critical parameters and understanding their scaling relationships to maintain CQAs
Q18. Which of the following is a typical output of a risk assessment in QbD?
- A list of prioritized CPPs and CQAs requiring control
- An unstructured narrative without actions
- A marketing plan for product launch
- A purchase order
Correct Answer: A list of prioritized CPPs and CQAs requiring control
Q19. Which experimental design is efficient when screening a large number of factors to identify the most important ones?
- Full factorial design for 20+ factors
- Fractional factorial design
- Single point study
- Case study
Correct Answer: Fractional factorial design
Q20. Which regulatory benefit is often mentioned for applying QbD?
- Automatic approval without submission
- Potential for more flexible post-approval change management within a justified design space
- Exemption from GMP inspections
- Reduced requirements for stability testing
Correct Answer: Potential for more flexible post-approval change management within a justified design space
Q21. What role does a control chart play in a QbD control strategy?
- It is used to visualize and detect process variation and trends over time
- It predicts marketing demand
- It sets cleaning schedules
- It lists supplier contacts
Correct Answer: It is used to visualize and detect process variation and trends over time
Q22. Robustness testing in QbD is intended to:
- Determine sensitivity of CQAs to small deliberate variations in process parameters
- Increase variability to test failure modes only
- Replace clinical outcomes
- Ensure only the lowest cost process is selected
Correct Answer: Determine sensitivity of CQAs to small deliberate variations in process parameters
Q23. Which of the following is a common CQA for a solid oral dosage form?
- Tablet hardness and dissolution profile
- Employee satisfaction index
- Warehouse lighting level
- Promotional brochure design
Correct Answer: Tablet hardness and dissolution profile
Q24. During DoE analysis, an interaction effect indicates:
- The combined effect of two factors is different from the sum of their single effects
- Factors have no impact on the response
- All factors are independent always
- That the experiment failed
Correct Answer: The combined effect of two factors is different from the sum of their single effects
Q25. Why is PAT integration valuable in QbD implementation?
- It enables real-time monitoring and control, reducing end-product testing and improving process understanding
- It replaces the need for trained operators
- It eliminates the need for raw material testing
- It increases manual sampling frequency only
Correct Answer: It enables real-time monitoring and control, reducing end-product testing and improving process understanding
Q26. What is the relationship between variability and product quality in a QbD framework?
- Understanding and controlling variability is central to ensuring consistent product quality
- Variability is not relevant if the average is within limits
- More variability always reduces costs
- Variability should be maximized to test robustness
Correct Answer: Understanding and controlling variability is central to ensuring consistent product quality
Q27. Which documentation is important to justify a proposed design space to regulators?
- Scientific rationale, DoE results, risk assessment, and control strategy
- Only the manufacturing cost sheet
- Only a one-line statement without data
- Marketing materials
Correct Answer: Scientific rationale, DoE results, risk assessment, and control strategy
Q28. In QbD, what is meant by “control strategy”?
- A set of controls, derived from product and process understanding, that ensures a process produces the intended product quality
- A staffing schedule for production shifts
- A list of potential vendors
- The packaging artwork approval workflow
Correct Answer: A set of controls, derived from product and process understanding, that ensures a process produces the intended product quality
Q29. Which of these is a common consequence of failing to identify a critical process parameter during development?
- Improved process robustness
- Unexpected product failures or out-of-specification batches during manufacturing
- Reduction in regulatory scrutiny
- Automatic product approval
Correct Answer: Unexpected product failures or out-of-specification batches during manufacturing
Q30. Which activity helps to translate QbD knowledge into routine production control?
- Ignoring DoE findings after development
- Implementing a documented control strategy with monitoring, PAT, and corrective actions based on risk assessment
- Replacing quality personnel yearly
- Only relying on end-product testing without process control
Correct Answer: Implementing a documented control strategy with monitoring, PAT, and corrective actions based on risk assessment
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com