Critical Quality Attributes (CQA) MCQs With Answer

Introduction: Critical Quality Attributes (CQA) MCQs With Answer provides M.Pharm students with a focused, advanced practice set on CQAs — the measurable physical, chemical, biological or microbiological characteristics that must be controlled to ensure product safety and efficacy. This collection emphasizes real-world pharmaceutical manufacturing scenarios, regulatory context (ICH Q8/Q9/Q10), analytical methods, risk assessment and control strategies central to Quality by Design (QbD). Questions probe identification, classification, analytical characterization and lifecycle management of CQAs across dosage forms including small molecules, biologics and sterile products, preparing students for examinations and practical decision-making in development, validation and regulatory submissions.

Q1. Which of the following best defines a Critical Quality Attribute (CQA)?

• A specification imposed by marketing to improve product aesthetics
• Any measurable attribute of a process irrespective of impact on product
• A physical, chemical, biological or microbiological property that should be within an appropriate limit to ensure product safety and efficacy
• An environmental parameter in the manufacturing facility

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

Q2. Which ICH guidance explicitly provides the most recognized definition and context for CQAs?

• ICH Q3C (Residual Solvents)
• ICH Q8(R2) (Pharmaceutical Development)
• ICH Q2 (Analytical Validation)
• ICH Q7 (GMP for APIs)

Correct Answer: ICH Q8(R2) (Pharmaceutical Development)

Q3. Which statement best describes a Critical Process Parameter (CPP)?

• A parameter that is only monitored during final release testing
• A process variable with negligible impact on product quality
• A process parameter whose variability has an impact on a CQA and should be controlled
• An attribute of raw material suppliers

Correct Answer: A process parameter whose variability has an impact on a CQA and should be controlled

Q4. Which of the following is least likely to be considered a CQA for most drug products?

• Assay (potency)
• Degradation product levels
• Packaging label text
• Dissolution profile for oral dosage forms

Correct Answer: Packaging label text

Q5. Which risk assessment tool is commonly used to rank potential CQAs by severity, occurrence and detectability?

• Design of Experiments (DoE)
• Failure Mode and Effects Analysis (FMEA)
• High Performance Liquid Chromatography (HPLC)
• Accelerated Stability Study

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q6. For monoclonal antibodies, which attribute is typically a critical quality attribute due to its impact on efficacy and immunogenicity?

• Tablet hardness
• Glycosylation pattern
• Residual solvent class
• Capsule disintegration time

Correct Answer: Glycosylation pattern

Q7. Which analytical technique is most appropriate for detecting and characterizing solid-state polymorphism as a CQA?

• Size-exclusion chromatography (SEC)
• X-ray powder diffraction (XRPD)
• Limulus amebocyte lysate (LAL) assay
• Karl Fischer titration

Correct Answer: X-ray powder diffraction (XRPD)

Q8. Which CQA most directly influences the dissolution rate of an immediate-release oral solid formulation?

• Particle size distribution of the active pharmaceutical ingredient
• Container closure system color
• Supplier country of origin
• Label font size

Correct Answer: Particle size distribution of the active pharmaceutical ingredient

Q9. For sterile parenteral products, which attribute is a critical quality attribute specifically related to pyrogenic risk?

• Microbial enumeration on agar plates
• Residual solvent level
• Endotoxin level (LAL results)
• Tablet friability

Correct Answer: Endotoxin level (LAL results)

Q10. Which ICH guidance categorizes and sets limits for residual solvents that may be CQAs in drug substances/formulations?

• ICH Q3C (Impurities: Guideline for Residual Solvents)
• ICH Q1A (Stability)
• ICH Q5C (Biotechnological Products)
• ICH Q2 (Analytical Validation)

Correct Answer: ICH Q3C (Impurities: Guideline for Residual Solvents)

Q11. Which parameters are most important to monitor as CQAs during stability studies for a small molecule drug product?

• Assay (potency) and levels of degradation products
• Employee training records and shift timings
• Building HVAC filter change dates
• Packaging artwork approval dates

Correct Answer: Assay (potency) and levels of degradation products

Q12. Which statistical metric is commonly used to evaluate whether a manufacturing process can consistently meet CQA specifications?

• Process capability indices (Cp and Cpk)
• Student’s t-test for two means
• ANOVA for formulation comparisons only
• Kaplan–Meier survival analysis

Correct Answer: Process capability indices (Cp and Cpk)

Q13. In a Quality by Design (QbD) workflow, at what stage are CQAs typically identified?

• During commercial launch only
• During product and process development using the Target Product Profile and risk assessment
• Only during routine stability testing after approval
• After market complaints arise

Correct Answer: During product and process development using the Target Product Profile and risk assessment

Q14. Which of the following is generally not considered a CQA for an immediate-release oral tablet?

• Dissolution
• Content uniformity
• Tablet color shade (minor color variation within specification)
• Assay (potency)

Correct Answer: Tablet color shade (minor color variation within specification)

Q15. Which analytical method is most appropriate for quantifying soluble aggregates of a therapeutic protein as a CQA?

• Size-exclusion chromatography (SEC)
• Gas chromatography (GC)
• XRPD
• UV–visible spot test

Correct Answer: Size-exclusion chromatography (SEC)

Q16. For inhalation drug products, which CQA most influences deposition in the lower respiratory tract?

• Aerodynamic particle size distribution (mass median aerodynamic diameter)
• Tablet disintegration time
• Residual ethyl acetate level
• Container label color

Correct Answer: Aerodynamic particle size distribution (mass median aerodynamic diameter)

Q17. Which of the following is an example of a physical CQA?

• Moisture content of a lyophilized cake
• Regulatory submission date
• Vendor contact details
• Marketing claims

Correct Answer: Moisture content of a lyophilized cake

Q18. Which element of a control strategy is designed to detect excursions in CQAs during manufacturing in real time?

• Routine annual training records
• Process Analytical Technology (PAT) and in-process controls
• Final print inspection of labels
• Post-market surveillance only

Correct Answer: Process Analytical Technology (PAT) and in-process controls

Q19. What primarily determines the acceptance criteria set for a given CQA?

• Clinical safety and efficacy considerations supported by risk assessment and regulatory requirements
• Color preference of the marketing team
• The calendar quarter in which the product is released
• Number of employees in the quality department

Correct Answer: Clinical safety and efficacy considerations supported by risk assessment and regulatory requirements

Q20. When should CQAs be re-evaluated during the product lifecycle?

• Only during initial development and never again
• Whenever there are changes to process, materials, analytical methods or new clinical/regulatory information
• Only after product recall
• Every day irrespective of changes

Correct Answer: Whenever there are changes to process, materials, analytical methods or new clinical/regulatory information

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