Requirements for drug industry location and facility design MCQs With Answer

Introduction:
This quiz collection focuses on the essential requirements for site selection and facility design in the pharmaceutical industry, tailored for M.Pharm students specializing in Quality Control & Quality Assurance. Topics covered include regulatory expectations (such as Schedule M and international GMP), layout principles to prevent cross-contamination, cleanroom classifications and airflow strategies, utilities (WFI, compressed air, HVAC), material and personnel flow, waste handling, and validation/qualification stages. These questions are designed to deepen conceptual understanding and application of standards when planning or auditing pharmaceutical manufacturing facilities. Use this set to test knowledge, prepare for viva/exams, and reinforce best practices for compliant, efficient, and contamination-controlled facility design.

Q1. Which of the following is a primary factor to consider when selecting a location for a pharmaceutical manufacturing site?

• Availability of utilities and infrastructure
• Proximity to tourist attractions
• Local cuisine diversity
• Number of shopping centers nearby

Correct Answer: Availability of utilities and infrastructure

Q2. Which regulatory document in India specifically details requirements for pharmaceutical manufacturing facilities and utilities?

• ICH Q7
• Schedule M of Drugs and Cosmetics Rules
• US FDA 21 CFR Part 11
• ISO 9001

Correct Answer: Schedule M of Drugs and Cosmetics Rules

Q3. To minimize cross-contamination, facility layout should primarily ensure which of the following?

• Unidirectional flow of products, materials and personnel with segregation of high-risk areas
• Maximum number of doors between departments
• Centralized mixing of incompatible products
• Interchangeable personnel entrances for all departments

Correct Answer: Unidirectional flow of products, materials and personnel with segregation of high-risk areas

Q4. What is the commonly accepted efficiency and particle size rating for HEPA filters used in pharmaceutical cleanrooms?

• 99.97% efficiency at 0.3 micrometers
• 95% efficiency at 10 micrometers
• 50% efficiency at 5 micrometers
• 99.99% efficiency at 5 micrometers

Correct Answer: 99.97% efficiency at 0.3 micrometers

Q5. Which cleanroom classification is typically required for aseptic filling operations?

• ISO 8
• ISO 7
• ISO 5
• ISO 9

Correct Answer: ISO 5

Q6. In cleanroom design, airflow should generally move in which direction to control contamination?

• From areas of higher cleanliness to areas of lower cleanliness
• From contaminated zones to critical product zones
• From outside corridor directly into aseptic filling
• From low temperature to high temperature zones only

Correct Answer: From areas of higher cleanliness to areas of lower cleanliness

Q7. Which of the following areas should be maintained at positive pressure relative to adjacent, less clean spaces?

• General storage for bulk non-sterile excipients
• Production cleanrooms for sterile product manufacturing
• External service corridors
• Waste holding rooms for contaminated materials

Correct Answer: Production cleanrooms for sterile product manufacturing

Q8. What is a key design principle for storage and distribution of Water for Injection (WFI) in a pharmaceutical facility?

• Use of a continuous loop circulating stainless steel system to avoid stagnation
• Storage in open tanks at ambient temperature
• Routing through painted carbon steel piping without insulation
• Intermittent batch storage in plastic drums

Correct Answer: Use of a continuous loop circulating stainless steel system to avoid stagnation

Q9. Compressed air used where it may contact product should be which of the following?

• Oil-lubricated with no filtration
• Oil-free, properly filtered and monitored for contaminants
• Ambient workshop air piped directly
• Only filtered for particles larger than 10 micrometers

Correct Answer: Oil-free, properly filtered and monitored for contaminants

Q10. What is the preferred direction of material flow inside a GMP facility to reduce contamination risk?

• From finished goods back to raw material storage
• From raw materials to intermediates to finished products, with separate dirty and clean flows
• Random movement according to convenience
• Materials flow combined with personnel traffic in the same corridors

Correct Answer: From raw materials to intermediates to finished products, with separate dirty and clean flows

Q11. Airlocks (vestibules) in a cleanroom system primarily serve to:

• Provide space for lunch breaks inside the controlled area
• Prevent particle ingress and maintain pressure differentials between zones
• Store excess equipment temporarily
• Allow direct external access for delivery trucks

Correct Answer: Prevent particle ingress and maintain pressure differentials between zones

Q12. Which gowning sequence is appropriate when entering a Grade A/B sterile area from a corridor?

• Put on gloves, then gown, then perform hand hygiene
• Hand hygiene → put on shoe covers → don gown → don mask and gloves
• Don mask only and enter
• Don gown outside, then perform hand hygiene after entering

Correct Answer: Hand hygiene → put on shoe covers → don gown → don mask and gloves

Q13. What is the correct sequence of qualification phases for a new facility or system?

• IQ → DQ → PQ → OQ
• DQ → IQ → OQ → PQ
• OQ → PQ → IQ → DQ
• PQ → IQ → DQ → OQ

Correct Answer: DQ → IQ → OQ → PQ

Q14. Which approach is essential for handling process effluents and hazardous waste from a drug facility?

• Combined discharge to municipal drains without treatment
• Segregated waste streams with containment and appropriate neutralization or treatment
• Dumping into onsite open pits
• Allowing evaporation in uncovered tanks

Correct Answer: Segregated waste streams with containment and appropriate neutralization or treatment

Q15. Surfaces and finishes inside production and cleanroom areas should be:

• Porous and rough to hide wear
• Smooth, non-shedding, corrosion-resistant and easily cleanable
• Painted with standard household paint
• Textured to provide grip and trap particles

Correct Answer: Smooth, non-shedding, corrosion-resistant and easily cleanable

Q16. What is the primary function of a buffer/change room between a general corridor and a clean manufacturing area?

• Provide storage for finished goods awaiting shipment
• Act as a controlled transition zone for gowning and to reduce contamination risk
• Host administrative meetings near production
• Serve as a chemical storage for raw solvents

Correct Answer: Act as a controlled transition zone for gowning and to reduce contamination risk

Q17. Which of the following is NOT typically a primary design objective for HVAC systems in pharmaceutical cleanrooms?

• Control of particulate and microbial contamination
• Control of temperature and relative humidity
• Control of pressure differentials between zones
• Control of ergonomics and staff morale

Correct Answer: Control of ergonomics and staff morale

Q18. Which design consideration is essential to ensure fire safety in a pharmaceutical facility?

• Elimination of all electrical installations
• Incorporation of fire detection, suppression systems and safe egress routes
• Storing flammable materials in production rooms without segregation
• Blocking emergency exits to improve security

Correct Answer: Incorporation of fire detection, suppression systems and safe egress routes

Q19. When selecting a site, why should proximity to heavy chemical plants or major pollution sources be avoided?

• They increase the risk of airborne contamination and regulatory complications
• They make it easier to source solvents locally
• They reduce land acquisition costs
• They guarantee skilled labor availability

Correct Answer: They increase the risk of airborne contamination and regulatory complications

Q20. What is a recommended location principle for the Quality Control (QC) laboratory within a pharmaceutical facility?

• Located in an unconditioned warehouse to save costs
• Situated adjacent to production with separate sample reception and controlled access to prevent cross-contamination
• Placed next to waste storage areas for convenience
• Located offsite without secure sample transport procedures

Correct Answer: Situated adjacent to production with separate sample reception and controlled access to prevent cross-contamination

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