Physical facilities and environment MCQs With Answer

Physical facilities and environment MCQs With Answer

Introduction: This quiz collection focuses on physical facilities and environmental aspects relevant to pharmaceutical research and practice, tailored for M.Pharm students. It covers laboratory design, cleanroom classification, HVAC systems, biosafety levels, contamination control, waste management, validation and calibration, and regulatory requirements such as GLP/GMP. Questions are designed to deepen understanding of how facility features impact product quality, data integrity, personnel safety and regulatory compliance. Use these MCQs to test knowledge, prepare for exams, and reinforce practical decision-making about facility planning, environmental monitoring, and risk mitigation in pharmaceutical research and manufacturing environments.

Q1. Which of the following is the primary objective of facility layout planning in a pharmaceutical laboratory?

• Maximize aesthetic appeal
• Minimize cross-contamination and optimize material and personnel flow
• Reduce the number of personnel required
• Increase ceiling heights for storage

Correct Answer: Minimize cross-contamination and optimize material and personnel flow

Q2. What is the principal function of HEPA filters in pharmaceutical cleanroom HVAC systems?

• Reduce room temperature
• Remove particulate contaminants down to specified micron sizes
• Sterilize air by killing microorganisms
• Reduce humidity to zero

Correct Answer: Remove particulate contaminants down to specified micron sizes

Q3. Which cleanroom classing system is commonly used internationally to specify particle count limits?

• USP only
• ISO cleanroom classification (ISO 14644)
• FDA Facility Classification Guide
• WHO GMP Annex

Correct Answer: ISO cleanroom classification (ISO 14644)

Q4. In a drug manufacturing facility, why is maintaining positive pressure used for certain rooms?

• To prevent heat loss
• To prevent ingress of contaminated air into the controlled area
• To ensure faster door operation
• To decrease power consumption of HVAC

Correct Answer: To prevent ingress of contaminated air into the controlled area

Q5. Which of the following is NOT a standard part of environmental monitoring in sterile manufacturing?

• Airborne particle counts
• Surface microbiological sampling
• Water flow cytometry for dissolved gases
• Active air sampling for viable organisms

Correct Answer: Water flow cytometry for dissolved gases

Q6. GLP (Good Laboratory Practice) requirements for facilities typically include which of the following?

• Documentation of facility design, maintenance and equipment qualification
• Only visual inspections without records
• Exclusive reliance on external contractors for maintenance with no oversight
• No need to segregate incompatible activities

Correct Answer: Documentation of facility design, maintenance and equipment qualification

Q7. A cleanroom required to maintain ISO Class 5 conditions is most likely to be used for which activity?

• Bulk storage of packaging materials
• Final filling and aseptic processing of sterile products
• Administrative offices
• General equipment maintenance

Correct Answer: Final filling and aseptic processing of sterile products

Q8. Which facility feature is essential to prevent cross-contamination between different product lines?

• Shared sinks between production and QC labs
• Dedicated HVAC systems and physical segregation with controlled personnel flow
• Using the same gowning area for all products
• Open access between production areas

Correct Answer: Dedicated HVAC systems and physical segregation with controlled personnel flow

Q9. What is the main reason for routine calibration of laboratory instruments in pharmaceutical facilities?

• To make instruments look new
• To ensure measurement accuracy and data integrity
• To increase instrument resale value
• To reduce instrument power consumption

Correct Answer: To ensure measurement accuracy and data integrity

Q10. Which of the following best defines a biosafety cabinet (BSC) primary purpose?

• Provide soundproofing for the lab
• Protect personnel, product, and environment from biological hazards depending on BSC class
• Serve as general storage for reagents
• Control room humidity

Correct Answer: Protect personnel, product, and environment from biological hazards depending on BSC class

Q11. In facility design for stability studies, what environmental control is most critical?

• Proper color lighting
• Precise temperature and relative humidity control with monitoring and alarm systems
• Open shelving near windows
• High frequency of foot traffic

Correct Answer: Precise temperature and relative humidity control with monitoring and alarm systems

Q12. Which practice helps reduce particulate generation inside a cleanroom?

• Wearing loose clothing during operations
• Proper gowning procedures and minimizing movement
• Frequent opening of doors to the outside
• Using fans to increase airflow within the room

Correct Answer: Proper gowning procedures and minimizing movement

Q13. What is the significance of having separate change rooms (airlocks) for entry and exit in controlled areas?

• To provide space for personal items
• To control contamination by staged gowning and to maintain pressure differentials
• To store experimental samples temporarily
• To reduce cleaning frequency in production areas

Correct Answer: To control contamination by staged gowning and to maintain pressure differentials

Q14. Which document defines the acceptable environmental conditions and monitoring frequency for a production area?

• Purchase order
• Site Master File and area-specific SOPs
• Employee resume
• Marketing plan

Correct Answer: Site Master File and area-specific SOPs

Q15. For hazardous chemical storage, what is an essential facility requirement?

• Storage in direct sunlight
• Segregation by hazard class with appropriate ventilation and secondary containment
• Mixing incompatible chemicals to save space
• Keeping doors permanently open for access

Correct Answer: Segregation by hazard class with appropriate ventilation and secondary containment

Q16. How is water for injection (WFI) distribution typically protected within a pharmaceutical facility?

• Using open reservoirs without circulation
• Closed loop distribution with periodic sanitization and monitoring for endotoxins
• Direct tap water connection without treatment
• Storage in unsealed containers in production areas

Correct Answer: Closed loop distribution with periodic sanitization and monitoring for endotoxins

Q17. What is the correct response when an environmental monitoring excursion occurs (e.g., elevated particle count) during a critical operation?

• Ignore it and continue production
• Quarantine affected batches, investigate root cause, and implement corrective and preventive actions (CAPA)
• Immediately dispose of all facility documentation
• Blame external suppliers without investigation

Correct Answer: Quarantine affected batches, investigate root cause, and implement corrective and preventive actions (CAPA)

Q18. Which of the following best describes the purpose of qualification (IQ/OQ/PQ) of facility systems?

• To check only the aesthetic aspects of the facility
• To verify installation, operation and performance meet specified requirements
• To avoid any future maintenance
• To postpone regulatory inspections

Correct Answer: To verify installation, operation and performance meet specified requirements

Q19. In designing a toxicology lab, which biosafety level (BSL) consideration is important?

• All toxicology labs must be BSL-4
• Select appropriate containment and PPE based on agent risk; many toxicology labs require BSL-2 or BSL-3 features depending on agents
• Biosafety level is irrelevant for toxicology
• Only administrative controls are necessary without engineering controls

Correct Answer: Select appropriate containment and PPE based on agent risk; many toxicology labs require BSL-2 or BSL-3 features depending on agents

Q20. Which utility is most critical to control for accurate analytical measurements in a pharmaceutical QC lab?

• Unfiltered compressed air for general use
• High purity gases (e.g., nitrogen, helium) and purified water supply free of contaminants
• Standard tap water without treatment
• Non-calibrated electronic balance

Correct Answer: High purity gases (e.g., nitrogen, helium) and purified water supply free of contaminants

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