This collection of Industrial Pharmacy II MCQs with answers is tailored for B.Pharm students to strengthen knowledge of pharmaceutical manufacturing, unit operations, aseptic processing, sterilization, validation and packaging. Covering granulation, drying, compression, coating, sterile production, cleanroom classifications, GMP, quality control, stability testing and scale-up, these questions balance theory with practical production scenarios. Emphasis is on process optimization, validation strategies, environmental monitoring and regulatory expectations, plus modern tools like PAT and pilot-plant workflow. Use these MCQs to revise critical concepts, improve problem-solving and prepare for exams and practical roles in industry. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which granulation technique is most suitable for heat-sensitive active pharmaceutical ingredients?
- High-shear wet granulation with heated air
- Dry (roller compaction) granulation
- Fluid bed drying with high inlet temperature
- Direct compression after wet milling
Correct Answer: Dry (roller compaction) granulation
Q2. What is the primary purpose of applying a film coating to tablets?
- To increase tablet disintegration time only
- To mask taste, improve stability and control release
- To reduce tablet weight
- To increase friability for easier breakage
Correct Answer: To mask taste, improve stability and control release
Q3. Which sterilization method is most appropriate for thermolabile parenteral solutions?
- Moist heat sterilization (autoclave)
- Dry heat sterilization
- Membrane filtration (sterile filtration)
- Radiation sterilization using high temperature
Correct Answer: Membrane filtration (sterile filtration)
Q4. In validation terminology, what does IQ stand for?
- Initial Qualification
- Installation Qualification
- Instrument Quality
- Integration Qualification
Correct Answer: Installation Qualification
Q5. Which parameter is most critical to control in aseptic processing to prevent contamination?
- Tablet hardness
- Air cleanliness and personnel practices
- Coating color consistency
- Packaging font size
Correct Answer: Air cleanliness and personnel practices
Q6. Which cleanroom classification (ISO) would typically be required for aseptic filling of sterile injectables?
- ISO Class 8
- ISO Class 7 for background and ISO Class 5 at the filling zone
- ISO Class 6 throughout
- ISO Class 9
Correct Answer: ISO Class 7 for background and ISO Class 5 at the filling zone
Q7. Which indicator is used as a biological indicator for steam sterilization effectiveness?
- Geobacillus stearothermophilus spores
- Bacillus subtilis var. niger spores
- Escherichia coli cultures
- Pseudomonas aeruginosa strains
Correct Answer: Geobacillus stearothermophilus spores
Q8. Which technique is commonly used for lyophilization to stabilize heat-sensitive biologics?
- Spray drying at high temperature
- Freeze-drying under reduced pressure
- Microwave-assisted drying
- Convective oven drying
Correct Answer: Freeze-drying under reduced pressure
Q9. What is the main aim of Process Analytical Technology (PAT) in pharmaceutical manufacturing?
- To replace quality control laboratories entirely
- To enable real-time monitoring and control of critical process parameters
- To reduce documentation requirements
- To standardize packaging artwork
Correct Answer: To enable real-time monitoring and control of critical process parameters
Q10. Which stability study condition corresponds to ICH long-term testing for Zone II (temperate) climates?
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
- 5°C ± 3°C refrigerated
Correct Answer: 25°C ± 2°C / 60% RH ± 5% RH
Q11. Which in-process control is essential during tablet compression to ensure uniformity?
- Particle size analysis of packaging film
- Weight variation and tablet hardness
- Visual color matching only
- Endotoxin testing
Correct Answer: Weight variation and tablet hardness
Q12. What is the main advantage of blister packaging for solid oral dosage forms?
- Increased bulk density
- Improved primary protection, dose-level identification and tamper evidence
- Lower manufacturing cost than bottles always
- Facilitates sterile parenteral filling
Correct Answer: Improved primary protection, dose-level identification and tamper evidence
Q13. Which material provides the best moisture barrier for sensitive solids?
- Polyethylene (PE)
- Aluminum foil laminate
- Paperboard
- Non-laminated PVC
Correct Answer: Aluminum foil laminate
Q14. During scale-up from laboratory to production, which principle is most critical to maintain product quality?
- Geometric similarity and maintenance of critical process parameters
- Increasing batch size without parameter checks
- Eliminating in-process controls to save time
- Changing excipients arbitrarily for cost
Correct Answer: Geometric similarity and maintenance of critical process parameters
Q15. Which test is employed to detect bacterial endotoxins in parenteral products?
- Sterility test using culture media
- Limulus Amebocyte Lysate (LAL) assay
- Total aerobic microbial count only
- pH determination
Correct Answer: Limulus Amebocyte Lysate (LAL) assay
Q16. What is the principal mechanism of dry heat sterilization?
- Protein coagulation by moist heat
- Oxidative damage and protein denaturation at high temperatures for prolonged time
- Membrane filtration of microorganisms
- Radiation penetration without heat
Correct Answer: Oxidative damage and protein denaturation at high temperatures for prolonged time
Q17. Which in-process control is typically measured during granulation to ensure proper binder distribution?
- Granule moisture content and size distribution
- Endotoxin level
- Film coating thickness only
- Packaging label alignment
Correct Answer: Granule moisture content and size distribution
Q18. What is a primary purpose of cleaning validation in pharmaceutical facilities?
- To reduce water consumption
- To demonstrate effective removal of product residues, cleaning agents and microbial contaminants
- To validate labels on packaging
- To test tablet disintegration times
Correct Answer: To demonstrate effective removal of product residues, cleaning agents and microbial contaminants
Q19. Which method is commonly used for sterility testing of large-volume parenterals?
- Membrane filtration followed by incubation in culture media
- Visual inspection only
- pH testing
- Endotoxin assay only
Correct Answer: Membrane filtration followed by incubation in culture media
Q20. Which coating type is used to achieve enteric release for tablet cores?
- Sugar coating
- Enteric polymer coating (e.g., Eudragit L)
- Immediate-release film coating without pH sensitivity
- Application of talc dust only
Correct Answer: Enteric polymer coating (e.g., Eudragit L)
Q21. What is the main role of a pilot plant in pharmaceutical development?
- To manufacture commercial batches only
- To evaluate scale-up, optimize processes and generate data for validation
- To replace R&D laboratories entirely
- To package finished products for market
Correct Answer: To evaluate scale-up, optimize processes and generate data for validation
Q22. Which environmental monitoring parameter is most relevant in sterile manufacturing suites?
- Ambient office noise level
- Airborne particle counts and viable microbial counts
- Tablet color uniformity
- Ink drying time on labels
Correct Answer: Airborne particle counts and viable microbial counts
Q23. Which document is central to GMP-compliant manufacturing, detailing every step and record for a specific batch?
- Marketing authorization dossier
- Master formula and Batch Manufacturing Record
- Employee handbook
- Maintenance log only
Correct Answer: Master formula and Batch Manufacturing Record
Q24. Which excipient property is most important to ensure adequate powder flow into tablet dies?
- High hygroscopicity
- Poor compressibility
- Good flowability and appropriate particle size
- Maximum moisture retention
Correct Answer: Good flowability and appropriate particle size
Q25. Which parameter indicates potential capping or lamination during tablet compression?
- Decrease in punch travel without changes in weight
- Excessive tablet hardness with no other issues
- Delamination, visible splitting, or popping during ejection
- Stable dissolution profile
Correct Answer: Delamination, visible splitting, or popping during ejection
Q26. Which packaging test assesses oxygen ingress for sensitive products?
- Water vapour transmission rate (WVTR) only
- Microbial limit test
- Oxygen transmission rate (OTR) measurement
- Color fastness testing
Correct Answer: Oxygen transmission rate (OTR) measurement
Q27. Which approach reduces microbial contamination risk from personnel in cleanrooms?
- Allow street clothes inside but require handwashing
- Strict gowning procedures, training and restricted movement
- Only wearing gloves without full gown
- No environmental monitoring
Correct Answer: Strict gowning procedures, training and restricted movement
Q28. What is the relationship between compression force and tablet hardness generally observed?
- Higher compression force typically decreases hardness
- Compression force does not affect hardness
- Higher compression force typically increases tablet hardness up to a point
- Tablet hardness is only determined by coating
Correct Answer: Higher compression force typically increases tablet hardness up to a point
Q29. Which test differentiates between disintegration and dissolution performance?
- Disintegration test measures breakup; dissolution measures drug release over time
- Dissolution measures tablet color change; disintegration measures weight loss
- Both tests are identical in principle
- Disintegration measures endotoxin levels
Correct Answer: Disintegration test measures breakup; dissolution measures drug release over time
Q30. Which regulatory expectation applies to in-process controls during commercial production?
- In-process controls may be omitted if final testing is performed
- They must be predefined, documented, and based on critical quality attributes
- They should be decided ad hoc by operators
- Only visual inspection is required
Correct Answer: They must be predefined, documented, and based on critical quality attributes
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