Manufacture of new drugs MCQs With Answer is a concise, keyword-rich review designed for B. Pharm students to master drug development and pharmaceutical manufacturing concepts. This collection covers API synthesis, preformulation, excipient selection, formulation design, scale-up, process validation, GMP, quality control, stability studies, analytical method validation, and regulatory (ICH) requirements. Questions delve into polymorphism, impurities, sterilization, aseptic processing, dissolution, bioavailability, and documentation to link theoretical principles with practical manufacturing scenarios. Ideal for exam preparation and applied learning, these MCQs reinforce critical thinking needed in industrial settings. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which study primarily evaluates the physicochemical properties of a drug candidate to guide formulation?
- Preformulation study
- Bioequivalence study
- Phase I clinical trial
- Post-marketing surveillance
Correct Answer: Preformulation study
Q2. What is the main purpose of process validation in drug manufacture?
- To demonstrate consistent production of quality batches
- To identify new drug targets
- To market the product globally
- To determine clinical dosing
Correct Answer: To demonstrate consistent production of quality batches
Q3. Which guideline outlines stability testing requirements for new drug substances and products?
- ICH Q1A
- ICH Q3A
- ICH Q7
- ICH Q9
Correct Answer: ICH Q1A
Q4. Which analytical technique is most commonly used for assay and impurity profiling in drug substances?
- High-performance liquid chromatography (HPLC)
- UV-Visible colorimetry
- Gravimetric analysis
- Titrimetry
Correct Answer: High-performance liquid chromatography (HPLC)
Q5. Which property of active pharmaceutical ingredient affects dissolution and bioavailability the most?
- Particle size and surface area
- Color and odor
- Packaging material
- Manufacturing site
Correct Answer: Particle size and surface area
Q6. Which process is used to remove solvents from a sterile solution under low temperature and vacuum?
- Lyophilization (freeze-drying)
- Spray drying
- Hot air oven drying
- Drum drying
Correct Answer: Lyophilization (freeze-drying)
Q7. What does GMP primarily ensure in pharmaceutical manufacture?
- Product quality, safety and compliance
- Maximum profit margins
- Faster clinical trials
- Patent protection
Correct Answer: Product quality, safety and compliance
Q8. Which ICH guideline deals with impurities in new drug products?
- ICH Q3A/Q3B
- ICH Q5C
- ICH Q11
- ICH Q2(R1)
Correct Answer: ICH Q3A/Q3B
Q9. Which excipient property is critical for tablet binding during granulation?
- Binder viscosity and plasticity
- Color intensity
- Flammability
- Thermal conductivity
Correct Answer: Binder viscosity and plasticity
Q10. Which stability test uses elevated temperature and humidity to predict long-term stability?
- Accelerated stability testing
- Real-time stability testing
- Photostability testing
- Microbial limit testing
Correct Answer: Accelerated stability testing
Q11. What is a stability-indicating method?
- An analytical method that accurately measures drug and degradation products
- A test for microbial contamination only
- A taste-masking evaluation
- A process control checklist
Correct Answer: An analytical method that accurately measures drug and degradation products
Q12. During scale-up, which parameter often requires re-optimization to maintain product quality?
- Mixing time and shear
- Marketing strategy
- Color of packaging
- Employee uniform size
Correct Answer: Mixing time and shear
Q13. Which test assesses uniform distribution of active ingredient in tablets?
- Content uniformity
- Dissolution profile
- pH measurement
- Viscosity test
Correct Answer: Content uniformity
Q14. What is the primary objective of forced degradation studies?
- To identify degradation pathways and develop stability-indicating assays
- To accelerate marketing approval
- To reduce manufacturing cost
- To measure tablet hardness
Correct Answer: To identify degradation pathways and develop stability-indicating assays
Q15. Which sterilization method is preferred for heat-sensitive parenterals?
- Gamma irradiation or filtration sterilization
- Moist heat autoclaving
- Dry heat sterilization
- Oven baking
Correct Answer: Gamma irradiation or filtration sterilization
Q16. Which regulatory document describes good manufacturing practice for APIs?
- ICH Q7
- ICH Q1A
- USP monograph
- ICH Q8
Correct Answer: ICH Q7
Q17. Which parameter is NOT typically part of analytical method validation?
- Flavor profile
- Accuracy
- Precision
- Specificity
Correct Answer: Flavor profile
Q18. What is polymorphism in pharmaceuticals?
- Existence of different crystalline forms of the same compound
- A type of microbial contamination
- Variation in capsule size only
- Difference in pharmacopoeial monographs
Correct Answer: Existence of different crystalline forms of the same compound
Q19. Which test is key for immediate-release tablets to predict in vivo performance?
- Dissolution testing
- Friability only
- Density measurement
- Moisture sorption isotherm
Correct Answer: Dissolution testing
Q20. Which parameter evaluates method precision over different days, analysts and equipment?
- Intermediate precision (ruggedness)
- Limit of detection
- System suitability only
- Linearity range
Correct Answer: Intermediate precision (ruggedness)
Q21. Which residual solvent class is considered highly toxic and should be limited?
- Class 1 solvents (e.g., benzene)
- Class 3 solvents (e.g., ethanol)
- Class 2 solvents (e.g., acetone)
- Water
Correct Answer: Class 1 solvents (e.g., benzene)
Q22. In aseptic processing, the most critical area for contamination control is:
- Critical area around product contact surfaces (aseptic zone)
- Administrative office
- Warehouse loading dock
- Cafeteria
Correct Answer: Critical area around product contact surfaces (aseptic zone)
Q23. Which in-process parameter is commonly monitored during tablet compression?
- Tablet weight and hardness
- Batch release date
- Employee attendance
- Marketing budget
Correct Answer: Tablet weight and hardness
Q24. Which microbial test is essential for sterile injectable products?
- Sterility test
- Total ash
- Disintegration test
- pH test
Correct Answer: Sterility test
Q25. What is a critical quality attribute (CQA)?
- A physical, chemical, biological or microbiological property that should be within limits to ensure quality
- An employee’s performance metric
- Only the tablet color
- A marketing claim
Correct Answer: A physical, chemical, biological or microbiological property that should be within limits to ensure quality
Q26. Which technique helps monitor critical process parameters in real time during manufacturing?
- Process Analytical Technology (PAT)
- Forced degradation
- Bulk density test
- Label design review
Correct Answer: Process Analytical Technology (PAT)
Q27. Which dissolution apparatus is commonly used for capsules and immediate-release tablets?
- USP Apparatus I (basket) and II (paddle)
- USP Apparatus IV only
- Karl Fischer apparatus
- Autoclave
Correct Answer: USP Apparatus I (basket) and II (paddle)
Q28. Which test measures particle size distribution critical for inhalation products?
- Aerodynamic particle size distribution (cascade impaction)
- pH measurement
- Viscosity at 25°C
- Loss on drying
Correct Answer: Aerodynamic particle size distribution (cascade impaction)
Q29. What is cleaning validation intended to demonstrate?
- Effective removal of residues and prevention of cross-contamination
- Employee cleaning schedules
- Stability of the product on the shelf
- Packaging integrity only
Correct Answer: Effective removal of residues and prevention of cross-contamination
Q30. Which documentation is essential to demonstrate traceability of each manufacturing step?
- Batch manufacturing record (BMR) and batch packaging record (BPR)
- Marketing brochures
- Employee payroll records
- Product brochure
Correct Answer: Batch manufacturing record (BMR) and batch packaging record (BPR)
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.
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