Quality by Design (QbD) is a systematic, science- and risk-based approach to pharmaceutical development that ensures consistent product quality. For B. Pharm students, understanding QbD tools — such as design of experiments (DoE), process analytical technology (PAT), risk assessment, control strategy, and multivariate analysis — is essential for modern drug development and regulatory compliance. Key concepts include identifying critical quality attributes (CQAs), critical process parameters (CPPs), and establishing robust control strategies to optimize formulation and manufacturing. This introduction links theory with practical applications, demonstrating how QbD improves product understanding, reduces variability, and facilitates lifecycle management. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary goal of Quality by Design (QbD) in pharmaceuticals?
- To reduce research costs by limiting experiments
- To ensure consistent product quality through a scientific, risk-based approach
- To increase production speed regardless of quality
- To replace regulatory oversight with internal audits
Correct Answer: To ensure consistent product quality through a scientific, risk-based approach
Q2. Which document provides global guidance specific to QbD concepts for pharmaceutical development?
- ICH Q8, Q9, and Q10 series
- USP General Chapters
- FDA 21 CFR Part 11
- EMA GMP Annex 1 only
Correct Answer: ICH Q8, Q9, and Q10 series
Q3. What does QTPP stand for in QbD terminology?
- Quality Time Production Plan
- Qualified Test Performance Parameters
- Quality Target Product Profile
- Quantitative Technical Process Points
Correct Answer: Quality Target Product Profile
Q4. Which of the following is considered a Critical Quality Attribute (CQA)?
- Tablet dissolution profile
- Company logo color
- Employee shift schedule
- Packaging supplier name
Correct Answer: Tablet dissolution profile
Q5. What is the role of risk assessment in QbD?
- To document marketing strategies
- To prioritize potential failure modes affecting CQAs and focus resources
- To replace DoE experiments completely
- To set prices for the final product
Correct Answer: To prioritize potential failure modes affecting CQAs and focus resources
Q6. Which tool is commonly used for initial risk identification in QbD?
- ANOVA
- Ishikawa (fishbone) diagram
- High performance liquid chromatography (HPLC)
- Stability chamber mapping
Correct Answer: Ishikawa (fishbone) diagram
Q7. Design of Experiments (DoE) primarily helps QbD by:
- Reducing the number of regulatory inspections
- Systematically studying the effect of multiple factors on responses
- Automatically setting CPP limits without experiments
- Replacing analytical method validation
Correct Answer: Systematically studying the effect of multiple factors on responses
Q8. Which DoE design is most appropriate for screening a large number of factors to identify the most significant?
- Central composite design
- Full factorial 3^k design
- Plackett-Burman design
- Response surface methodology (RSM)
Correct Answer: Plackett-Burman design
Q9. What is a design space in QbD?
- The geographic location of the manufacturing plant
- The multidimensional combination of input variables and process parameters that provide assurance of quality
- A fixed set of release specifications that cannot be changed
- A marketing segmentation plan
Correct Answer: The multidimensional combination of input variables and process parameters that provide assurance of quality
Q10. Which analytical approach is part of PAT (Process Analytical Technology)?
- Near-infrared spectroscopy (NIR)
- Survey questionnaires
- Financial audits
- Batch record printing
Correct Answer: Near-infrared spectroscopy (NIR)
Q11. What does CPP stand for and why is it important?
- Critical Production Plan; used for marketing
- Critical Process Parameter; influences CQAs and must be controlled
- Common Product Procedure; used only in R&D
- Controlled Packaging Process; only for labeling
Correct Answer: Critical Process Parameter; influences CQAs and must be controlled
Q12. Which statistical method is commonly used to analyze DoE results?
- ANOVA (Analysis of Variance)
- Kaplan-Meier analysis
- Fourier transform
- Linear regression without variance analysis
Correct Answer: ANOVA (Analysis of Variance)
Q13. In QbD, what is the significance of robustness testing?
- To test marketing robustness
- To evaluate the effect of small, deliberate variations on product quality
- To examine the durability of packaging only
- To validate software code
Correct Answer: To evaluate the effect of small, deliberate variations on product quality
Q14. Which multivariate technique is often used for process understanding and monitoring?
- PCA (Principal Component Analysis)
- Kaplan-Meier estimator
- One-way ANOVA only
- FMEA without statistics
Correct Answer: PCA (Principal Component Analysis)
Q15. What does FMEA stand for and how does it relate to QbD?
- Failure Mode and Effects Analysis; a risk tool to identify and prioritize failure modes
- Frequency Mapping and Evaluation Algorithm; used for spectrometry
- Final Material Evaluation Assessment; used for raw material release
- Formulation Matrix and Emulsion Analysis; used in creams only
Correct Answer: Failure Mode and Effects Analysis; a risk tool to identify and prioritize failure modes
Q16. Which of the following is NOT typically an application of QbD?
- Formulation optimization
- Process scale-up and transfer
- Robustness and stability studies
- Setting retail pricing strategies
Correct Answer: Setting retail pricing strategies
Q17. What is the relationship between QTPP and CQAs?
- CQAs are derived from the QTPP to ensure product meets intended quality and performance
- QTPP is developed after CQAs are finalized and unrelated to them
- CQAs replace the need for a QTPP
- QTPP is only used for marketing claims, not CQAs
Correct Answer: CQAs are derived from the QTPP to ensure product meets intended quality and performance
Q18. Which control strategy element is important for maintaining product quality during routine manufacturing?
- Uncontrolled batch variability
- Continuous monitoring via PAT and defined operating ranges for CPPs
- Random operator discretion
- Elimination of in-process controls
Correct Answer: Continuous monitoring via PAT and defined operating ranges for CPPs
Q19. What is the main advantage of using response surface methodology (RSM) in DoE?
- It screens a large number of factors quickly
- It helps model curvature and locate optimal factor settings
- It reduces the number of quality attributes
- It automates regulatory submissions
Correct Answer: It helps model curvature and locate optimal factor settings
Q20. Which statement best describes a control strategy?
- A plan that defines how to produce, control, and ensure product quality throughout the lifecycle
- A checklist for marketing approvals
- A method for legal compliance without scientific basis
- A procurement schedule for raw materials only
Correct Answer: A plan that defines how to produce, control, and ensure product quality throughout the lifecycle
Q21. Which of the following is an example of a process analytical technology (PAT) application?
- Offline HPLC analysis only after batch completion
- Real-time NIR monitoring of moisture during drying
- Monthly inventory audits
- Employee satisfaction surveys
Correct Answer: Real-time NIR monitoring of moisture during drying
Q22. In QbD, what is meant by ‘lifecycle management’?
- Managing product quality from development through discontinuation with continuous improvement
- Only the initial product registration phase
- Marketing the product over its commercial life
- Human resource management for the product team
Correct Answer: Managing product quality from development through discontinuation with continuous improvement
Q23. Which experimental design is best for exploring curvature with few factors?
- Plackett-Burman design
- Central Composite Design (CCD)
- One-factor-at-a-time
- Completely randomized block design
Correct Answer: Central Composite Design (CCD)
Q24. What role does multivariate data analysis (MVDA) play in QbD?
- It simplifies complex, correlated process data to reveal relationships and trends
- It is used only for financial forecasting
- It replaces basic quality control charts entirely
- It only applies to tablet coatings
Correct Answer: It simplifies complex, correlated process data to reveal relationships and trends
Q25. Which of the following is a common performance indicator for a QbD program?
- Number of marketing brochures produced
- Reduction in batch-to-batch variability and deviations
- Average employee commute time
- Amount spent on office supplies
Correct Answer: Reduction in batch-to-batch variability and deviations
Q26. How does QbD facilitate regulatory flexibility?
- By allowing companies to ignore specifications
- By providing science-based justification (e.g., design space) for operating ranges and changes
- By eliminating the need for approvals
- By delaying product submissions
Correct Answer: By providing science-based justification (e.g., design space) for operating ranges and changes
Q27. Which is an example of a critical material attribute (CMA)?
- Tablet color preference
- API particle size distribution affecting dissolution
- Office lighting
- Supplier office location
Correct Answer: API particle size distribution affecting dissolution
Q28. What is the purpose of performing robustness studies during product development?
- To define the impact of small deliberate variations on CQAs and establish acceptable ranges
- To limit the number of stability samples
- To maximize production cost savings without testing
- To certify packaging aesthetics only
Correct Answer: To define the impact of small deliberate variations on CQAs and establish acceptable ranges
Q29. Which of the following best describes ‘control limits’ within a QbD control strategy?
- Regulatory fines for non-compliance
- Defined acceptable ranges for CPPs and in-process measurements that maintain CQAs
- Financial limits for quality expenditure
- Employee performance thresholds
Correct Answer: Defined acceptable ranges for CPPs and in-process measurements that maintain CQAs
Q30. During scale-up, which QbD practice helps predict and mitigate scale-dependent risks?
- Ignoring scale differences and using identical settings
- Using DoE, process modeling, and risk assessment to understand scale effects
- Only increasing batch size without modeling
- Changing raw materials without testing
Correct Answer: Using DoE, process modeling, and risk assessment to understand scale effects
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