Development of pharmaceutical industry and organizations MCQs With Answer

Development of pharmaceutical industry and organizations MCQs With Answer

The development of the pharmaceutical industry covers drug discovery, formulation, clinical trials, regulatory affairs, manufacturing, quality control, and pharmacovigilance. For B. Pharm students, understanding organizational structures—regulatory bodies (FDA, EMA, CDSCO), CROs, CMOs, and QA/QC departments—is essential. Key concepts include GMP, GLP, GCP, CTD/DMF dossiers, API and excipient sourcing, stability studies, technology transfer, and quality-by-design (QbD). Grasping these topics prepares students for roles in production, regulatory submissions, quality assurance, and drug safety. This MCQ set emphasizes practical knowledge and exam-relevant facts on the growth and governance of pharmaceutical organizations. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which regulatory document outlines international guidelines for quality, safety, and efficacy harmonization in pharmaceuticals?

• Good Manufacturing Practices (GMP)
• International Council for Harmonisation (ICH) guidelines
• World Health Organization Essential Medicines List
• Pharmacopoeial Monographs

Correct Answer: International Council for Harmonisation (ICH) guidelines

Q2. What is the primary purpose of Good Manufacturing Practices (GMP) in pharmaceutical production?

• To speed up clinical trials
• To ensure consistent product quality and patient safety
• To reduce raw material costs
• To promote marketing strategies

Correct Answer: To ensure consistent product quality and patient safety

Q3. Which organization typically conducts pre-approval inspections for manufacturing facilities in the United States?

• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization)
• FDA (Food and Drug Administration)
• WHO (World Health Organization)

Correct Answer: FDA (Food and Drug Administration)

Q4. What does ANDA stand for and which product type does it apply to?

• Abbreviated New Drug Application; generic drugs
• Application for New Drug Approval; biologics
• Authorized New Drug Application; orphan drugs
• Abbreviated New Device Application; medical devices

Correct Answer: Abbreviated New Drug Application; generic drugs

Q5. Which phase of clinical trials primarily assesses efficacy and side effects in a larger patient group?

• Phase I
• Phase II
• Phase III
• Phase IV

Correct Answer: Phase III

Q6. In a pharmaceutical company, which department is chiefly responsible for product release and batch record review?

• Research and Development (R&D)
• Quality Assurance (QA)
• Regulatory Affairs
• Sales and Marketing

Correct Answer: Quality Assurance (QA)

Q7. What is an API in pharmaceutical manufacturing?

• Applied Production Instrument
• Active Pharmaceutical Ingredient
• Analytical Process Indicator
• Approved Packaging Index

Correct Answer: Active Pharmaceutical Ingredient

Q8. Which guideline focuses specifically on pharmaceutical quality systems for manufacturing APIs?

• ICH Q8 (Pharmaceutical Development)
• ICH Q9 (Quality Risk Management)
• ICH Q7 (Good Manufacturing Practice for APIs)
• ICH E6 (Good Clinical Practice)

Correct Answer: ICH Q7 (Good Manufacturing Practice for APIs)

Q9. What is the main role of a Contract Research Organization (CRO) in drug development?

• Manufacture finished drug products
• Provide outsourced research services, especially clinical trials
• Regulate marketing authorizations
• Distribute medicines globally

Correct Answer: Provide outsourced research services, especially clinical trials

Q10. Which dossier format is commonly used for regulatory submissions worldwide?

• Common Technical Document (CTD)
• Drug Master File (DMF)
• Biologic License Application (BLA)
• New Drug Evaluation File (NDEF)

Correct Answer: Common Technical Document (CTD)

Q11. What is the purpose of stability studies in pharmaceuticals?

• To evaluate marketing potential
• To determine shelf life and storage conditions
• To test patient compliance
• To measure production speed

Correct Answer: To determine shelf life and storage conditions

Q12. Which term describes the progressive global adoption of science-based drug regulation and standards?

• Pharmacoeconomics
• Regulatory convergence
• Market liberalization
• Clinical decentralization

Correct Answer: Regulatory convergence

Q13. What is pharmacovigilance primarily concerned with?

• Drug price control
• Monitoring and prevention of adverse drug reactions
• Designing drug molecules
• Scaling up manufacturing processes

Correct Answer: Monitoring and prevention of adverse drug reactions

Q14. Which GMP concept emphasizes designing quality into products and processes?

• Quality by Design (QbD)
• Total Quality Management (TQM)
• Good Laboratory Practice (GLP)
• Post-marketing surveillance

Correct Answer: Quality by Design (QbD)

Q15. What is the role of a Contract Manufacturing Organization (CMO)?

• Provide clinical monitoring services
• Outsource commercial drug production and packaging
• Grant marketing authorizations
• Develop new chemical entities

Correct Answer: Outsource commercial drug production and packaging

Q16. Which document contains detailed methods for analytical testing in a regulatory submission?

• Investigator’s Brochure
• Quality Target Product Profile (QTPP)
• Analytical Method Validation report within the CTD
• Clinical Study Protocol

Correct Answer: Analytical Method Validation report within the CTD

Q17. What is a bioequivalence study required for?

• Approval of new chemical entities
• Demonstrating equivalence between a generic and reference product
• Testing sterilization processes
• Conducting stability-indicating assays

Correct Answer: Demonstrating equivalence between a generic and reference product

Q18. Which ICH guideline focuses on stability testing of new drug substances and products?

• ICH Q1A(R2)
• ICH Q3A
• ICH M4
• ICH Q10

Correct Answer: ICH Q1A(R2)

Q19. In manufacturing, what is validation primarily intended to demonstrate?

• That the process consistently produces a product meeting predetermined specifications
• That raw materials are inexpensive
• That marketing claims are valid
• That regulatory filings were accepted

Correct Answer: That the process consistently produces a product meeting predetermined specifications

Q20. What is an orphan drug designation intended to encourage?

• Development of treatments for common diseases
• Development of treatments for rare diseases
• Faster approval of generics
• Removal of patent protections

Correct Answer: Development of treatments for rare diseases

Q21. Which practice governs the ethical conduct of clinical trials?

• Good Laboratory Practice (GLP)
• Good Clinical Practice (GCP)
• Good Distribution Practice (GDP)
• Pharmacoeconomics

Correct Answer: Good Clinical Practice (GCP)

Q22. Which is a primary responsibility of Regulatory Affairs in a pharmaceutical company?

• Conducting stability chambers
• Preparing and submitting marketing authorization dossiers
• Running routine QC assays
• Packaging finished goods

Correct Answer: Preparing and submitting marketing authorization dossiers

Q23. What defines a biosimilar product?

• An identical chemical copy of a small-molecule drug
• A highly similar biological product to an approved reference biologic with no clinically meaningful differences
• A generic herbal formulation
• A novel vaccine under development

Correct Answer: A highly similar biological product to an approved reference biologic with no clinically meaningful differences

Q24. What is a Drug Master File (DMF) used for?

• To list adverse drug reactions
• To provide confidential manufacturing, chemistry, and controls information about an API to regulators
• To obtain patents
• To register clinical trial sites

Correct Answer: To provide confidential manufacturing, chemistry, and controls information about an API to regulators

Q25. Which quality attribute is assessed by dissolution testing for oral solid dosage forms?

• Moisture content
• Rate and extent of drug release
• Particle size distribution
• Microbial load

Correct Answer: Rate and extent of drug release

Q26. What is the significance of a stability-indicating method?

• It measures marketing uptake
• It specifically detects the drug and its degradation products for stability assessment
• It improves tablet hardness
• It validates clinical endpoints

Correct Answer: It specifically detects the drug and its degradation products for stability assessment

Q27. What does QA investigation of an OOS (Out of Specification) result typically require?

• Immediate product launch
• Root cause analysis, retesting, and CAPA (Corrective and Preventive Action)
• Marketing the batch as-is
• Ignoring the result if within label claims

Correct Answer: Root cause analysis, retesting, and CAPA (Corrective and Preventive Action)

Q28. Which supply-chain practice helps prevent counterfeit medicines reaching patients?

• Serialization and track-and-trace systems
• Reducing shelf life
• Increasing batch sizes
• Using only local suppliers

Correct Answer: Serialization and track-and-trace systems

Q29. What is technology transfer in the pharmaceutical industry?

• Moving regulatory authority from one country to another
• Transferring knowledge, processes, and documentation from development to commercial manufacturing or between sites
• Exporting finished products
• Transferring patents to competitors

Correct Answer: Transferring knowledge, processes, and documentation from development to commercial manufacturing or between sites

Q30. Which element is essential in a pharmaceutical Quality Management System (QMS)?

• Uncontrolled change management
• Documented procedures, change control, CAPA, and management review
• Absence of training programs
• Ignoring supplier qualification

Correct Answer: Documented procedures, change control, CAPA, and management review

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