Introduction: The “Conditions for grant of manufacturing license MCQs With Answer” is a focused study resource designed for B.Pharm students to master regulatory requirements for drug manufacturing. This concise guide emphasizes key keywords such as manufacturing license, conditions for grant, Good Manufacturing Practices (GMP), quality control laboratory, drug inspector, plant layout, technical staff, records and documentation, stability testing, and regulatory compliance. It explains the statutory and practical prerequisites—premises, equipment, qualified personnel, validated processes, SOPs and documentation—that regulators check before issuing a license. The material is ideal for exam revision and practical understanding of regulatory inspections and compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of the conditions for grant of a manufacturing license?
- To increase production output regardless of quality
- To ensure compliance with GMP and regulatory standards for safety and quality
- To control market prices of finished products
- To promote only multinational manufacturers
Correct Answer: To ensure compliance with GMP and regulatory standards for safety and quality
Q2. Who normally conducts inspection of premises before granting a manufacturing license?
- Sales Representative
- Drug Inspector or authorized regulatory official
- Hospital Administrator
- Local Chamber of Commerce
Correct Answer: Drug Inspector or authorized regulatory official
Q3. Which of the following is a mandatory requirement for a pharmaceutical manufacturing license?
- Quality control laboratory with adequate equipment
- On-site cafeteria for visitors
- Marketing office in multiple cities
- Exclusive retail outlet
Correct Answer: Quality control laboratory with adequate equipment
Q4. Schedule M in pharmaceutical regulation primarily deals with:
- Taxation rules for drug companies
- Good Manufacturing Practices and requirements for premises, equipment and personnel
- Advertising standards for medicines
- Export-import tariff classifications
Correct Answer: Good Manufacturing Practices and requirements for premises, equipment and personnel
Q5. Which documentation is essential to demonstrate batch-wise production control?
- Batch Manufacturing Record (BMR)
- Company brochure
- Staff attendance register only
- Marketing strategy plan
Correct Answer: Batch Manufacturing Record (BMR)
Q6. What is the role of qualified technical personnel in license conditions?
- They are optional and only for large companies
- They ensure scientific oversight, supervise production and quality control
- They handle sales and distribution exclusively
- They manage canteen services
Correct Answer: They ensure scientific oversight, supervise production and quality control
Q7. Which aspect is inspected under premises during licensing?
- Proximity to entertainment zones
- Layout for material flow, clean areas, ventilation and waste disposal
- Number of parking slots
- Color of exterior paint
Correct Answer: Layout for material flow, clean areas, ventilation and waste disposal
Q8. Validation of manufacturing processes is required to:
- Increase employee count
- Demonstrate consistent production of quality product within specified limits
- Reduce raw material costs only
- Comply with environmental permits only
Correct Answer: Demonstrate consistent production of quality product within specified limits
Q9. Which of the following is a key requirement for quality control laboratories?
- Unrecorded test methods
- Use of validated test methods, calibrated instruments and trained analysts
- Only visual inspection without instruments
- Testing by external unapproved labs exclusively
Correct Answer: Use of validated test methods, calibrated instruments and trained analysts
Q10. How should records and documents be maintained as per licensing conditions?
- Casually, without retention periods
- Systematically with controlled document change, retention and retrieval
- Destroyed daily
- Kept only in personal files of managers
Correct Answer: Systematically with controlled document change, retention and retrieval
Q11. Which control is essential for incoming raw materials?
- Visual check only
- Receipt, identity testing, quarantine and release after quality acceptance
- Immediate release to production without testing
- Storage with finished products
Correct Answer: Receipt, identity testing, quarantine and release after quality acceptance
Q12. Stability testing requirements for a product are included in license conditions to assess:
- Marketing potential
- Shelf life, storage conditions and degradation profile of the product
- Packaging color preferences
- Employee satisfaction
Correct Answer: Shelf life, storage conditions and degradation profile of the product
Q13. Which practice helps prevent cross-contamination in manufacturing?
- Dedicated equipment or validated cleaning procedures and segregated areas
- Using same equipment for all products without cleaning
- Mixing different products intentionally
- Allowing open access between lines
Correct Answer: Dedicated equipment or validated cleaning procedures and segregated areas
Q14. What is the significance of Standard Operating Procedures (SOPs) in licensing?
- SOPs are optional suggestions
- SOPs provide written, auditable instructions to ensure consistent operations and compliance
- SOPs are only for marketing staff
- SOPs replace training requirements
Correct Answer: SOPs provide written, auditable instructions to ensure consistent operations and compliance
Q15. Which action is typically required when there is a change in site or ownership of a licensed facility?
- No action needed
- Intimation to regulatory authority and possible fresh inspection or application amendment
- Only inform customers
- Transfer license informally by phone
Correct Answer: Intimation to regulatory authority and possible fresh inspection or application amendment
Q16. Why are environmental control systems important in manufacturing areas?
- They enhance product aesthetics only
- They control temperature, humidity and air quality to protect product integrity
- They are installed for marketing purposes
- They reduce staff working hours
Correct Answer: They control temperature, humidity and air quality to protect product integrity
Q17. Which of the following is a typical inspection finding that may delay license grant?
- Comprehensive documentation
- Non-compliance with GMP, such as inadequate QC or poor sanitation
- Well-trained personnel
- Validated processes
Correct Answer: Non-compliance with GMP, such as inadequate QC or poor sanitation
Q18. In the context of licensing, what is the purpose of product recall procedures?
- To increase sales
- To effectively remove defective or unsafe batches from distribution to protect patients
- To minimize employee responsibility
- To promote new products
Correct Answer: To effectively remove defective or unsafe batches from distribution to protect patients
Q19. Which personnel qualification is commonly required for overseeing a pharmaceutical manufacturing unit?
- Qualified pharmacist or person with specified pharmaceutical/technical degree and experience
- Only a high school diploma
- Untrained volunteers
- Marketing executives
Correct Answer: Qualified pharmacist or person with specified pharmaceutical/technical degree and experience
Q20. Why is calibration of instruments emphasized in licensing conditions?
- Calibration is decorative
- To ensure accuracy and reliability of test and process measurements
- To increase power consumption
- To train non-technical staff
Correct Answer: To ensure accuracy and reliability of test and process measurements
Q21. Which record is essential for traceability of a finished batch?
- Batch Manufacturing Record including raw material lot numbers and test results
- Only the invoice copy
- Staff monthly payslips
- External advertisements
Correct Answer: Batch Manufacturing Record including raw material lot numbers and test results
Q22. What is meant by “quarantine” in raw material handling?
- Materials stored for immediate use without checks
- Segregation of incoming materials until quality approval
- Discarding all incoming materials
- Using materials past expiry
Correct Answer: Segregation of incoming materials until quality approval
Q23. Which factor influences approval of manufacturing license for sterile products specifically?
- Sterile area design, validated aseptic processes and environmental monitoring
- Only color of packaging
- Number of marketing staff
- Location near a shopping mall
Correct Answer: Sterile area design, validated aseptic processes and environmental monitoring
Q24. What is the importance of a documented qualification program (IQ/OQ/PQ)?
- It is optional and for aesthetics
- It demonstrates that equipment and processes operate as intended and are fit for use
- It is only for legal teams
- It replaces QC testing
Correct Answer: It demonstrates that equipment and processes operate as intended and are fit for use
Q25. Which practice is critical to prevent mix-ups of labels and packaging materials?
- Random storage of labels
- Controlled labeling area, reconciliation procedures and separate storage
- Using handwritten labels only
- Allowing any staff to pick labels freely
Correct Answer: Controlled labeling area, reconciliation procedures and separate storage
Q26. During licensing inspections, why is personnel hygiene evaluated?
- To ensure personnel wear fashionable clothes
- To reduce risk of contamination and ensure safe handling of materials
- To limit staff movement
- To track employee attendance
Correct Answer: To reduce risk of contamination and ensure safe handling of materials
Q27. Which of the following is part of Good Documentation Practice (GDP)?
- Backdating entries to suit reports
- Legible records, dated entries, initials and controlled corrections
- Erasing errors without trace
- Multiple conflicting versions
Correct Answer: Legible records, dated entries, initials and controlled corrections
Q28. How should deviations from approved procedures be handled according to license conditions?
- Ignored and not recorded
- Documented, investigated, impact assessed and corrective actions implemented
- Hidden to avoid inspection
- Reported only verbally to colleagues
Correct Answer: Documented, investigated, impact assessed and corrective actions implemented
Q29. Which of the following is a requirement for storage of finished pharmaceutical products?
- Random stacking without records
- Controlled conditions, proper shelving, stock rotation and documented records
- Storage with raw waste
- Exposure to direct sunlight for durability
Correct Answer: Controlled conditions, proper shelving, stock rotation and documented records
Q30. What is a likely regulatory expectation regarding secondary packaging and labeling under license conditions?
- No label content required
- Accurate, legible labels with required statutory information and batch identification
- Labels may be generic and nonspecific
- Labels can be handwritten without control
Correct Answer: Accurate, legible labels with required statutory information and batch identification
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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