This quiz collection on Facility and Equipment System Inspection is tailored for M.Pharm students preparing for Quality Management Systems (MQA 102T). It focuses on practical and regulatory aspects of inspection, qualification, maintenance, calibration and documentation for pharmaceutical facilities and equipment. Questions examine HVAC, cleanrooms, utilities (WFI, compressed air), IQ/OQ/PQ, inspection checklists, deviation handling, sterile processing controls and preventive maintenance strategies. Each multiple-choice item aims to deepen understanding of inspection criteria, acceptance limits and risk-based prioritization used during audits and regulatory inspections. Use these MCQs to reinforce concepts essential for ensuring GMP-compliant facility and equipment management.
Q1. What is the primary objective of equipment qualification (IQ/OQ/PQ) during facility inspection?
- To verify the cleanliness of the equipment only
- To demonstrate that equipment is installed, operates and performs consistently as intended
- To ensure personnel are trained to use the equipment
- To validate cleaning procedures for related processes
Correct Answer: To demonstrate that equipment is installed, operates and performs consistently as intended
Q2. During a GMP inspection of HVAC systems in a cleanroom, which parameter is most critical for maintaining directional airflow?
- Temperature stability
- Relative humidity control
- Pressure differential between zones
- Air change rate per hour only
Correct Answer: Pressure differential between zones
Q3. Which document should define the scope, responsibilities and acceptance criteria for routine equipment inspections?
- Calibration certificate
- Cleaning validation report
- Equipment maintenance log only
- Inspection procedure or SOP
Correct Answer: Inspection procedure or SOP
Q4. What is the best practice frequency for calibrating critical instruments used in release testing?
- Only when they fail
- At manufacturer recommended intervals or based on risk assessment
- Once every five years
- Whenever new personnel start using them
Correct Answer: At manufacturer recommended intervals or based on risk assessment
Q5. In an equipment inspection, identification of non-conforming parts or repairs should be documented where?
- Only in the maintenance technician’s mind
- In the equipment’s history file or maintenance record
- In a separate binder unrelated to the equipment
- Only in the next annual audit report
Correct Answer: In the equipment’s history file or maintenance record
Q6. Which utility is most critical to inspect for microbial control in sterile product manufacturing?
- Cooling water for HVAC
- Compressed air intended for direct product contact
- Domestic potable water
- Plant sewage system
Correct Answer: Compressed air intended for direct product contact
Q7. What is the role of a calibration label attached to a measuring device during inspections?
- Decoration only
- To indicate calibration status and next due date
- To show the price of the instrument
- To identify the vendor
Correct Answer: To indicate calibration status and next due date
Q8. Which of the following is a key acceptance criterion in performance qualification (PQ) of a sterilizer?
- Operator comfort during loading
- Achieving required biological indicators or sterility assurance levels consistently
- Paint condition of the chamber
- Color of process indicator tapes
Correct Answer: Achieving required biological indicators or sterility assurance levels consistently
Q9. During a facility inspection, what is the inspector likely to review to confirm contamination control measures for personnel?
- Gowning procedures and monitoring records
- Employee payroll records
- Building architectural drawings
- Fire evacuation drills
Correct Answer: Gowning procedures and monitoring records
Q10. Which inspection activity helps verify that cleaning procedures for equipment are effective?
- Reviewing cleaning SOPs without records
- Visual inspection plus swab or rinse sampling and analytical testing
- Counting cleaning brushes
- Checking paint finish of equipment
Correct Answer: Visual inspection plus swab or rinse sampling and analytical testing
Q11. What is a critical element to check during inspection of the Water for Injection (WFI) generation system?
- Presence of white labels only
- Microbiological and endotoxin monitoring results and distribution loop integrity
- Color of the piping insulation
- Number of faucets in the facility
Correct Answer: Microbiological and endotoxin monitoring results and distribution loop integrity
Q12. Which practice should an inspector verify to ensure computerized equipment systems are compliant?
- That the software is visually attractive
- Existence of validated software, access control, audit trails and backup procedures
- That the vendor supports the product
- Only that the system boots up
Correct Answer: Existence of validated software, access control, audit trails and backup procedures
Q13. What is the purpose of an Equipment Master Record in inspections?
- To store employee details
- To detail equipment design, critical parameters, maintenance and calibration requirements
- To act as an invoice log
- To list building contractors
Correct Answer: To detail equipment design, critical parameters, maintenance and calibration requirements
Q14. During inspection, how should deviations found during equipment qualification be handled?
- Ignored if minor
- Documented, investigated for root cause and dispositioned with corrective actions
- Erased from the report
- Left for the next team to address
Correct Answer: Documented, investigated for root cause and dispositioned with corrective actions
Q15. What is the significance of particle count monitoring in a cleanroom inspection?
- It measures chemical contamination only
- It provides quantitative evidence of airborne particulate control versus classification limits
- It indicates the color of airborne particles
- It replaces surface microbiological testing
Correct Answer: It provides quantitative evidence of airborne particulate control versus classification limits
Q16. Which inspection item is essential when reviewing preventive maintenance (PM) programs for critical equipment?
- Frequency based purely on vendor marketing
- PM schedule, records of performed tasks, and effectiveness reviews based on failure trends
- Only the spare parts inventory
- Maintenance staff uniforms
Correct Answer: PM schedule, records of performed tasks, and effectiveness reviews based on failure trends
Q17. In facility inspections, what is the correct action if a compressed air system used for product contact fails microbial testing?
- Continue using it until resolved months later
- Quarantine affected products, investigate source, remediate and revalidate before resuming use
- Replace all equipment immediately
- Only increase filtration without investigation
Correct Answer: Quarantine affected products, investigate source, remediate and revalidate before resuming use
Q18. Which record demonstrates that an equipment change (e.g., retrofit) was assessed for impact on validated state?
- Change control with validation impact assessment and updated PQ/OQ documentation
- Vendor marketing brochure
- Daily production log
- Employee lunch schedule
Correct Answer: Change control with validation impact assessment and updated PQ/OQ documentation
Q19. For sterile manufacturing, what inspection evidence demonstrates adequate environmental monitoring (EM) program performance?
- Random non-documented samples
- Trend data showing compliance with alert/action limits and documented investigations of excursions
- Only one-time passing EM result
- Paint quality in the laboratory
Correct Answer: Trend data showing compliance with alert/action limits and documented investigations of excursions
Q20. What is a risk-based focus an inspector should use when auditing facility and equipment inspection programs?
- Focus only on non-essential cosmetic issues
- Prioritize systems that impact product quality, patient safety and regulatory compliance
- Concentrate only on paperwork presentation
- Inspect only during weekends
Correct Answer: Prioritize systems that impact product quality, patient safety and regulatory compliance
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