Introduction: Basic regulatory terminology and definitions MCQs With Answer is an essential study resource for B.Pharm students preparing for regulatory affairs, quality assurance, and pharmaceutical development roles. This concise guide covers key terms—GMP, GLP, GCP, IND, NDA, ANDA, CTD/eCTD, pharmacovigilance, ADR/SAE/SUSAR, stability, SOPs, validation, CAPA, QA vs QC, and regulatory authorities like FDA, EMA and ICH. Clear definitions and practical examples deepen understanding of compliance, dossier preparation, safety reporting, and product lifecycle management. Strengthen your professional vocabulary and exam readiness with targeted questions that reflect real-world regulatory practice. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary role of regulatory affairs in the pharmaceutical industry?
- Overseeing marketing campaigns for medicines
- Ensuring products comply with laws and regulations
- Designing chemical synthesis routes
- Managing hospital pharmacy inventories
Correct Answer: Ensuring products comply with laws and regulations
Q2. What does GMP stand for and what is its main purpose?
- Good Marketing Practice; to promote drugs
- Good Manufacturing Practice; to ensure consistent product quality
- General Medical Procedures; to standardize treatments
- Good Management Process; to improve company profits
Correct Answer: Good Manufacturing Practice; to ensure consistent product quality
Q3. Which guideline primarily governs non-clinical laboratory studies and their quality?
- GCP (Good Clinical Practice)
- GMP (Good Manufacturing Practice)
- GLP (Good Laboratory Practice)
- GDP (Good Documentation Practice)
Correct Answer: GLP (Good Laboratory Practice)
Q4. GCP is most relevant to which activity?
- Clinical trial design, conduct and reporting
- Cleaning validation in manufacturing
- Packaging and labeling approval
- Analytical method transfer
Correct Answer: Clinical trial design, conduct and reporting
Q5. What does IND refer to in regulatory submissions?
- International New Declaration
- Investigational New Drug application
- Initial Marketing Dossier
- Information for New Dosage forms
Correct Answer: Investigational New Drug application
Q6. What is an NDA?
- New Drug Application for marketing approval of a new drug
- National Drug Authorization for import permits
- Nonclinical Data Archive
- Notification of Drug Availability
Correct Answer: New Drug Application for marketing approval of a new drug
Q7. ANDA is used to apply for approval of which product type?
- Biologic license products
- Generic versions of approved small-molecule drugs
- Over-the-counter herbal supplements
- New molecular entities with novel mechanisms
Correct Answer: Generic versions of approved small-molecule drugs
Q8. How many modules are there in the Common Technical Document (CTD)?
- 3
- 5
- 7
- 10
Correct Answer: 5
Q9. What does eCTD mean?
- electronic Common Technical Document for regulatory submission
- enhanced Clinical Trial Data
- electronic Clinical Trial Database
- estimated Common Technical Duration
Correct Answer: electronic Common Technical Document for regulatory submission
Q10. What is a Marketing Authorization (MA)?
- A contract to sell medicines on private platforms
- Official approval to market a medicinal product in a region
- A laboratory certificate for starting clinical trials
- A patent granted to a drug inventor
Correct Answer: Official approval to market a medicinal product in a region
Q11. Pharmacovigilance primarily focuses on:
- Drug manufacturing yield improvement
- Monitoring and preventing adverse effects of medicines
- Marketing drugs to healthcare professionals
- Assessing drug stability under accelerated conditions
Correct Answer: Monitoring and preventing adverse effects of medicines
Q12. What is the definition of an ADR?
- Antibiotic Drug Reaction
- Adverse Drug Reaction — a harmful or unpleasant response related to use of a drug
- Authorized Drug Release
- Approximate Dose Range
Correct Answer: Adverse Drug Reaction — a harmful or unpleasant response related to use of a drug
Q13. Which outcome qualifies an adverse event as a Serious Adverse Event (SAE)?
- Minor skin irritation that resolves quickly
- Temporary headache not requiring medical care
- Hospitalization, death, or life‑threatening event
- Expected mild gastrointestinal upset
Correct Answer: Hospitalization, death, or life‑threatening event
Q14. SUSAR stands for:
- Suspected Unrelated Serious Adverse Reaction
- Suspected Unexpected Serious Adverse Reaction
- Standardized Unexpected Safety Assessment Report
- Safety Update Summary and Adverse Report
Correct Answer: Suspected Unexpected Serious Adverse Reaction
Q15. What is the purpose of a Periodic Safety Update Report (PSUR)?
- To request extension of a drug patent
- To periodically summarize a product’s safety data and evaluate risk–benefit
- To document manufacturing batch yields
- To report stability failures to regulators
Correct Answer: To periodically summarize a product’s safety data and evaluate risk–benefit
Q16. The Risk Management Plan (RMP) is designed to:
- Outline marketing strategies for a drug
- Describe identified and potential safety concerns and measures to minimize risk
- Detail the clinical manufacturing process steps
- Report daily quality control test results
Correct Answer: Describe identified and potential safety concerns and measures to minimize risk
Q17. Which best describes the difference between QA and QC?
- QA focuses on marketing; QC focuses on sales
- QA ensures processes and systems; QC performs product testing
- QA writes lab reports; QC conducts clinical trials
- QA purchases raw materials; QC ships finished goods
Correct Answer: QA ensures processes and systems; QC performs product testing
Q18. What is the primary purpose of an SOP in a pharmaceutical setting?
- To provide flexible guidelines that can be ignored when needed
- To standardize procedures and ensure reproducible compliance
- To replace regulatory requirements
- To advertise company policies externally
Correct Answer: To standardize procedures and ensure reproducible compliance
Q19. Change control in a regulated environment refers to:
- Uncontrolled ad‑hoc changes to speed up production
- A formal process to evaluate, approve, and document changes affecting product or system
- Changing marketing slogans annually
- Adjusting clinical protocols without documentation
Correct Answer: A formal process to evaluate, approve, and document changes affecting product or system
Q20. Stability studies are conducted primarily to determine:
- The most profitable sales period for a drug
- Shelf life, storage conditions and expiry of a pharmaceutical product
- The taste preference of patients
- Batch-to-batch color differences only
Correct Answer: Shelf life, storage conditions and expiry of a pharmaceutical product
Q21. What does ICH stand for and why is it important?
- Institute of Clinical Histories; stores patient records
- International Council for Harmonisation; it harmonizes technical guidelines across regions
- Internal Chemical Handling; for lab safety
- International Clinical Hub; a site for trials
Correct Answer: International Council for Harmonisation; it harmonizes technical guidelines across regions
Q22. Which validation type demonstrates that a manufacturing process consistently produces a product meeting predetermined specifications?
- Analytical validation
- Process validation
- Method transfer validation
- Computer system validation
Correct Answer: Process validation
Q23. A Critical Quality Attribute (CQA) is best described as:
- An attribute unrelated to patient safety
- A physical, chemical, biological or microbiological property that should be within limits to ensure product quality
- A marketing metric for prescribing trends
- The cost metric for raw materials
Correct Answer: A physical, chemical, biological or microbiological property that should be within limits to ensure product quality
Q24. CAPA stands for and serves to:
- Corrective and Preventive Action; address root causes and prevent recurrence
- Corrective Analysis of Product Attributes; increase potency
- Clinical Assessment of Patient Adverse events; for marketing use
- Computerized Analytical Process Automation; for manufacturing robotics
Correct Answer: Corrective and Preventive Action; address root causes and prevent recurrence
Q25. What does batch release mean in a regulated manufacturing context?
- Selling leftover raw materials
- Formal authorization to distribute a production batch after QA/QC review
- Discarding nonconforming batches without documentation
- Beginning production of a new batch
Correct Answer: Formal authorization to distribute a production batch after QA/QC review
Q26. Which information is typically required on a pharmaceutical product label by regulators?
- Company profit margins
- Active ingredient, strength, dosage instructions, storage conditions, expiry
- Internal batch records
- Manufacturing equipment serial numbers
Correct Answer: Active ingredient, strength, dosage instructions, storage conditions, expiry
Q27. Bioequivalence studies are conducted to demonstrate that a generic product:
- Has identical excipients to the innovator
- Provides similar rate and extent of absorption as the reference product
- Is cheaper than the reference product
- Has the same color and shape as the innovator tablet
Correct Answer: Provides similar rate and extent of absorption as the reference product
Q28. Therapeutic equivalence implies that two products:
- Are produced by the same manufacturer
- Can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified
- Have identical packaging
- Are both over‑the‑counter medications
Correct Answer: Can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified
Q29. An orphan drug designation is granted to medicines intended to treat:
- Common cold and flu
- Rare diseases or conditions affecting small patient populations
- Only pediatric conditions common worldwide
- Cosmetic concerns
Correct Answer: Rare diseases or conditions affecting small patient populations
Q30. What is the purpose of a Master Batch Record (MBR)?
- To summarize sales data for a product
- To provide detailed, authorized instructions for manufacture of a specific product batch
- To list employee attendance
- To store marketing authorizations
Correct Answer: To provide detailed, authorized instructions for manufacture of a specific product batch
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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