Introduction to pharmaceutical product development MCQs With Answer

Introduction to pharmaceutical product development MCQs With Answer

This concise, student-focused resource covers core concepts in pharmaceutical product development for B. Pharm students, including preformulation studies, formulation development, stability testing, regulatory affairs, GMP, quality control, bioavailability, scale-up and technology transfer. Emphasis is on practical topics such as excipient selection, analytical method validation, dissolution testing, ICH guidelines (Q1–Q11), QbD, PAT and bioequivalence principles. These MCQs will reinforce formulation strategies, stability protocols, process validation and regulatory documentation used in modern drug development and manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which primary objective of preformulation studies is most critical for designing an oral solid dosage form?

• Measuring tablet hardness after compression
• Evaluating physicochemical properties like solubility, pKa and stability
• Selecting packaging materials
• Estimating market demand

Correct Answer: Evaluating physicochemical properties like solubility, pKa and stability

Q2. What is the earliest stage in pharmaceutical product development?

• Clinical trials
• Formulation optimization
• Preformulation studies
• Regulatory submission

Correct Answer: Preformulation studies

Q3. BCS classification is based on which two drug properties?

• Melting point and hygroscopicity
• Solubility and intestinal permeability
• Particle size and polymorphism
• pKa and log P

Correct Answer: Solubility and intestinal permeability

Q4. Which ICH guideline specifically provides recommendations on stability testing of new drug substances and products?

• ICH Q8
• ICH Q1A
• ICH Q9
• ICH Q3A

Correct Answer: ICH Q1A

Q5. Which dissolution apparatus is most commonly used for immediate-release tablets in routine quality control?

• USP Apparatus 4 (flow-through cell)
• USP Apparatus 2 (paddle)
• USP Apparatus 1 (basket)
• USP Apparatus 7 (reciprocating cylinder)

Correct Answer: USP Apparatus 2 (paddle)

Q6. In analytical method validation, which term describes the closeness of repeated measurements to each other?

• Accuracy
• Specificity
• Precision
• Linearity

Correct Answer: Precision

Q7. Which type of process validation is typically performed before commercial production begins?

• Prospective validation
• Concurrent validation
• Retrospective validation
• Predictive validation

Correct Answer: Prospective validation

Q8. What is the primary function of a binder in a tablet formulation?

• Enhance disintegration
• Improve flow
• Promote granule cohesion to form tablets
• Act as a lubricant at die walls

Correct Answer: Promote granule cohesion to form tablets

Q9. What characteristic defines a stability-indicating analytical method?

• High throughput capability
• Ability to separate drug from its degradation products
• Use of mass spectrometry only
• Requires no sample preparation

Correct Answer: Ability to separate drug from its degradation products

Q10. Which Quality by Design (QbD) tool is commonly used to identify critical formulation and process variables?

• One-factor-at-a-time testing
• Design of Experiments (DoE)
• End-of-line inspection
• Randomized clinical trial

Correct Answer: Design of Experiments (DoE)

Q11. Which technique is most effective at increasing dissolution rate by reducing drug particle size?

• Spray drying without size control
• Micronization
• Using a higher melting point excipient
• Coating with enteric polymer

Correct Answer: Micronization

Q12. What are the standard ICH accelerated stability conditions for long-term solid oral dosage forms?

• 25°C/40% RH
• 30°C/65% RH
• 40°C/75% RH
• 10°C/0% RH

Correct Answer: 40°C/75% RH

Q13. What does CTD stand for in regulatory submissions?

• Clinical Trial Data
• Common Technical Document
• Certification of Therapeutic Drug
• Critical Testing Dossier

Correct Answer: Common Technical Document

Q14. For bioequivalence studies, the accepted 90% confidence interval for AUC and Cmax ratio is typically:

• 50–150%
• 75–125%
• 80–125%
• 90–110%

Correct Answer: 80–125%

Q15. Lyophilization (freeze-drying) is most appropriate for which type of pharmaceuticals?

• Heat-stable tablets
• Thermolabile biologicals and parenterals
• Immediate-release capsules
• Non-aqueous ointments

Correct Answer: Thermolabile biologicals and parenterals

Q16. Which ICH guideline focuses on pharmaceutical development principles and content?

• ICH Q8
• ICH Q4
• ICH Q11
• ICH Q2

Correct Answer: ICH Q8

Q17. When comparing dissolution profiles, an f2 similarity factor value of ≥50 indicates what?

• Profiles are dissimilar
• Profiles are identical
• Profiles are similar
• Profiles are inverted

Correct Answer: Profiles are similar

Q18. What is the primary purpose of a pilot plant in product development?

• Final marketing of the product
• Large-scale distribution
• Optimize manufacturing processes and scale-up before commercial production
• Conduct clinical trials

Correct Answer: Optimize manufacturing processes and scale-up before commercial production

Q19. Which sterilization approach is preferred when the product is compatible with heat?

• Filtration sterilization only
• Radiation sterilization only
• Terminal sterilization
• No sterilization is needed

Correct Answer: Terminal sterilization

Q20. How is “shelf-life” of a pharmaceutical product defined?

• Time until expiration of patent
• Time period product remains within approved specifications under recommended storage
• Time required for manufacturing
• Time taken to reach peak plasma concentration

Correct Answer: Time period product remains within approved specifications under recommended storage

Q21. What is the primary objective of cleaning validation in manufacturing?

• Ensure cosmetic appearance of equipment
• Confirm removal of microbial contamination only
• Demonstrate removal of product residues and contaminants to acceptable limits
• Validate personnel training procedures

Correct Answer: Demonstrate removal of product residues and contaminants to acceptable limits

Q22. What is the function of a plasticizer in polymer film coating?

• Increase coating brittleness
• Improve film flexibility and reduce cracking
• Act as an abrasive agent
• Decrease tablet dissolution rate permanently

Correct Answer: Improve film flexibility and reduce cracking

Q23. Which ICH guideline addresses Quality Risk Management?

• ICH Q5
• ICH Q12
• ICH Q9
• ICH Q3

Correct Answer: ICH Q9

Q24. For poorly soluble (BCS Class II) oral drugs, which factor most often limits oral bioavailability?

• Hepatic metabolism
• Renal excretion
• Dissolution rate and solubility
• Plasma protein binding

Correct Answer: Dissolution rate and solubility

Q25. In reverse-phase HPLC, how can you increase retention time of a nonpolar analyte?

• Increase the percentage of organic solvent in the mobile phase
• Decrease the percentage of organic solvent in the mobile phase
• Use a shorter column with larger particle size
• Increase column temperature only

Correct Answer: Decrease the percentage of organic solvent in the mobile phase

Q26. Why are drug–excipient compatibility studies important during formulation development?

• They determine tablet color
• They predict potential interactions that may affect stability and efficacy
• They assess marketing preferences
• They replace the need for stability testing

Correct Answer: They predict potential interactions that may affect stability and efficacy

Q27. Which statement best describes a Level A IVIVC (in vitro–in vivo correlation)?

• Categorical correlation between dosage forms
• Point-to-point correlation between in vitro dissolution and in vivo input rate
• Qualitative relationship only
• Correlation using animal data only

Correct Answer: Point-to-point correlation between in vitro dissolution and in vivo input rate

Q28. Which regulatory submission is required in the USA for approval of a generic drug?

• NDA (New Drug Application)
• ANDA (Abbreviated New Drug Application)
• IND (Investigational New Drug)
• MAA (Marketing Authorization Application)

Correct Answer: ANDA (Abbreviated New Drug Application)

Q29. What does PAT stand for in modern pharmaceutical manufacturing?

• Product Approval Timeline
• Process Analytical Technology
• Pharmacovigilance and Testing
• Production Automation Tools

Correct Answer: Process Analytical Technology

Q30. Which hazard is considered a major risk for product quality during pharmaceutical manufacturing?

• Cross-contamination between products
• Excessive packaging aesthetics
• Having too much shelf space
• High sales volume

Correct Answer: Cross-contamination between products

G S Sachin

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