Conditions of license for manufacture of drugs MCQs With Answer offers B. Pharm students a concise, practical guide to regulatory compliance and inspection readiness. This introduction covers essential keywords such as licensing authority, Good Manufacturing Practices (GMP), Schedule M, quality control laboratory, validation, batch records, stability studies, personnel qualifications and recall procedures. The focus is on application of license conditions to premises, equipment, documentation, sterility, water quality and change control within the Drugs and Cosmetics regulatory framework, helping you master both theory and practical compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of imposing conditions on a manufacturing license for drugs?
- To ensure product safety and consistent quality
- To limit the number of manufacturers
- To control drug pricing
- To promote export only
Correct Answer: To ensure product safety and consistent quality
Q2. Which regulatory concept is central to most license conditions for drug manufacture?
- Good Clinical Practice (GCP)
- Good Agricultural Practice (GAP)
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
Correct Answer: Good Manufacturing Practice (GMP)
Q3. In the Indian regulatory context, which schedule primarily defines GMP standards for pharmaceutical manufacturing?
- Schedule X
- Schedule D
- Schedule M
- Schedule Y
Correct Answer: Schedule M
Q4. Which of the following is typically mandated as part of license conditions regarding personnel?
- Appointment of qualified technical staff responsible for production and quality
- Only sales staff qualifications
- No requirement for trained staff
- Only contractual labor is permitted
Correct Answer: Appointment of qualified technical staff responsible for production and quality
Q5. Which requirement is commonly expected for licensed manufacturing premises?
- Adequate premises, properly designed to prevent contamination
- Any available building without controls
- Open storage near waste drains
- Shared premises with food processing units
Correct Answer: Adequate premises, properly designed to prevent contamination
Q6. What documentation must be maintained for each manufactured batch as per standard license conditions?
- Batch manufacturing records and batch processing documentation
- Only sales invoices
- Only personnel attendance sheets
- Only supplier catalogues
Correct Answer: Batch manufacturing records and batch processing documentation
Q7. Why are stability studies required under licensing conditions?
- To establish shelf life and expiry dating
- To increase marketing claims
- To reduce production costs
- To determine color preferences
Correct Answer: To establish shelf life and expiry dating
Q8. Which environmental control is essential for aseptic or sterile production areas?
- Controlled air quality, pressure differentials and clean zones
- Open ventilation to outside air
- No specific control other than cleaning
- Storage of raw materials inside production zone
Correct Answer: Controlled air quality, pressure differentials and clean zones
Q9. For parenteral product manufacture, which water quality is typically required?
- Tap water
- Distilled water
- Water for Injection (WFI)
- Boiled potable water
Correct Answer: Water for Injection (WFI)
Q10. What action can the licensing authority take when a manufacturer fails to comply with license conditions?
- Suspend or cancel the manufacturing license
- Double the production quota
- Automatically renew the license
- Transfer the license to another manufacturer
Correct Answer: Suspend or cancel the manufacturing license
Q11. Renewal of a manufacturing license generally requires submission of which of the following?
- Application form and required fees
- Only verbal request
- Advertising copies
- No documentation
Correct Answer: Application form and required fees
Q12. Standard Operating Procedures (SOPs) are required to cover which aspects in a licensed facility?
- Cleaning, operation, testing and deviations
- Only payroll processing
- Only sales procedures
- Only parking rules
Correct Answer: Cleaning, operation, testing and deviations
Q13. Which labeling elements are commonly required by license conditions?
- Batch number, manufacturing date and expiry date
- Only brand logo
- Only price details
- Only manufacturer’s slogan
Correct Answer: Batch number, manufacturing date and expiry date
Q14. A licensed manufacturer must maintain a quality control laboratory capable of which functions?
- Raw material, in-process and finished product testing
- Only packaging design
- Only sales forecasting
- Only customer service
Correct Answer: Raw material, in-process and finished product testing
Q15. What is a core requirement of an effective product recall procedure under license conditions?
- Traceability and a written recall plan with defined responsibilities
- No documentation is required
- Only public advertising of recall
- Recall only if court orders
Correct Answer: Traceability and a written recall plan with defined responsibilities
Q16. How should significant changes in manufacturing process, site or equipment be handled under license conditions?
- Through change control with intimation to or approval from the licensing authority and revalidation
- Implemented immediately without records
- Hidden from authorities
- Only communicated to sales team
Correct Answer: Through change control with intimation to or approval from the licensing authority and revalidation
Q17. Who is normally authorized to release a finished batch for sale in a licensed facility?
- The qualified person or responsible officer after quality review
- The junior office assistant
- The marketing executive
- The external transporter
Correct Answer: The qualified person or responsible officer after quality review
Q18. What is the purpose of keeping retention samples as required by license conditions?
- To enable investigation of complaints and quality issues
- For employee refreshments
- To display in marketing promotions
- To sell at discounts later
Correct Answer: To enable investigation of complaints and quality issues
Q19. Why is cleaning validation an important license requirement?
- To ensure residues do not contaminate subsequent batches and to demonstrate reproducible cleaning
- To delay production
- To reduce water usage only
- To improve color of equipment
Correct Answer: To ensure residues do not contaminate subsequent batches and to demonstrate reproducible cleaning
Q20. Good documentation practices required by licensing conditions include which elements?
- Accurate records, dated entries, signatures and controlled changes
- Only handwritten notes without dates
- Only electronic files without access control
- No record retention
Correct Answer: Accurate records, dated entries, signatures and controlled changes
Q21. Personnel-related license conditions commonly require which of the following?
- Medical examination and ongoing training of production staff
- Only recruitment without training
- No health checks at all
- Only seasonal hiring
Correct Answer: Medical examination and ongoing training of production staff
Q22. Under license conditions, manufacturers have a responsibility for which post-marketing activity?
- Pharmacovigilance and adverse event reporting
- Only increasing sales
- Only social media promotion
- No post-marketing responsibilities
Correct Answer: Pharmacovigilance and adverse event reporting
Q23. Proper disposal of manufacturing waste as part of license conditions aims to prevent what?
- Environmental contamination and cross-contamination of products
- Increase in production yield
- Faster packaging
- Promotion of waste resale
Correct Answer: Environmental contamination and cross-contamination of products
Q24. Can the licensing authority collect samples from a manufacturing site for independent testing?
- Yes, the authority can sample and send for independent analysis
- No, only the manufacturer can test
- Only sales samples can be tested
- Sampling is prohibited
Correct Answer: Yes, the authority can sample and send for independent analysis
Q25. What is required for analytical methods used in release testing under license conditions?
- Validated, stability-indicating analytical methods
- Only visual inspection
- Only vendor certificates without testing
- Random unvalidated methods
Correct Answer: Validated, stability-indicating analytical methods
Q26. Good documentation practice requires which action when correcting an entry in a batch record?
- Crossing out with a single line, initialing, dating and providing a reason
- Erasing without trace
- Using white-out to hide the mistake
- Rewriting the entire page without justification
Correct Answer: Crossing out with a single line, initialing, dating and providing a reason
Q27. Which of the following is NOT a legitimate condition of a manufacturing license?
- Guarantee of market monopoly
- Requirement for quality control facilities
- Compliance with GMP
- Maintenance of batch records
Correct Answer: Guarantee of market monopoly
Q28. A required element of a quality assurance system under license conditions is:
- Periodic internal audits and management review
- Only external advertising
- Only sales meetings
- No review processes
Correct Answer: Periodic internal audits and management review
Q29. Who typically conducts official inspections to verify compliance with license conditions?
- Inspectors from the licensing authority or drug control department
- Local marketing agents
- Company janitorial staff
- Random customers
Correct Answer: Inspectors from the licensing authority or drug control department
Q30. For sterile product license compliance, which of the following is essential?
- Aseptic processing areas, validated sterilization and trained personnel
- Only attractive packaging
- Only long working hours
- No documentation
Correct Answer: Aseptic processing areas, validated sterilization and trained personnel
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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