Good Laboratory Practice (GLP) mandates specific facilities and equipment requirements to ensure reliable, reproducible pharmaceutical research and safety. B.Pharm students should understand laboratory layout, environmental controls (HVAC, humidity, temperature), utilities (purified water, compressed air), instrument qualification (IQ/OQ/PQ), calibration, validation, preventive maintenance, documentation, sample storage, biosafety cabinets, waste management and quality assurance systems. Proper selection, installation, calibration and routine verification of analytical balances, HPLC, microscopes, autoclaves and cold storage are essential for data integrity and regulatory compliance. Familiarity with SOPs, traceability, certified reference materials and training requirements helps prevent errors. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which document best describes the physical layout requirements, workflow and segregation of activities for a GLP-compliant laboratory?
- Facility Master Plan
- Analytical Method Validation Report
- Equipment Calibration Log
- Personnel Training Matrix
Correct Answer: Facility Master Plan
Q2. What is the primary purpose of HVAC control in a GLP laboratory?
- To reduce electricity consumption
- To maintain environmental conditions for data integrity and sample stability
- To provide internet connectivity to instruments
- To sterilize laboratory equipment
Correct Answer: To maintain environmental conditions for data integrity and sample stability
Q3. Which qualification stage verifies that equipment is installed according to manufacturer and specification requirements?
- Performance Qualification (PQ)
- Operational Qualification (OQ)
- Installation Qualification (IQ)
- Design Qualification (DQ)
Correct Answer: Installation Qualification (IQ)
Q4. For an HPLC system used in GLP testing, which activity is essential to ensure accurate quantitation over time?
- Changing the column brand weekly
- Routine calibration and system suitability testing
- Running only reference standards once a year
- Storing samples at room temperature indefinitely
Correct Answer: Routine calibration and system suitability testing
Q5. Which water grade is typically required for HPLC mobile phases and critical analytical applications in GLP labs?
- Tap water
- RO water
- Type I ultrapure water
- Bottled distilled water
Correct Answer: Type I ultrapure water
Q6. What is the main reason for maintaining Calibration Certificates for critical laboratory instruments?
- To demonstrate compliance and traceability to national standards
- To increase instrument resale value
- To justify equipment purchases
- To decorate the instrument manual
Correct Answer: To demonstrate compliance and traceability to national standards
Q7. Which piece of equipment is essential for maintaining aseptic manipulations and protecting samples from contamination?
- Fume hood
- Biosafety cabinet (Class II)
- Analytical balance
- Refrigerated centrifuge
Correct Answer: Biosafety cabinet (Class II)
Q8. Under GLP, what is the correct action when an instrument fails its performance verification?
- Continue using it until replacement arrives
- Document the failure, quarantine the instrument, and investigate root cause
- Ignore the result if previous data looked fine
- Remove all labels and keep using it secretly
Correct Answer: Document the failure, quarantine the instrument, and investigate root cause
Q9. What is a critical requirement for storage of reference standards in a GLP facility?
- Store standards by alphabetical order only
- Maintain controlled conditions with documented traceability and certificates
- Keep all standards at room temperature regardless of label
- Mix different standards together to save space
Correct Answer: Maintain controlled conditions with documented traceability and certificates
Q10. Which routine activity ensures balances provide accurate mass measurements for GLP analyses?
- Daily drip cleaning with solvents
- Frequent tare resets without calibration
- Regular calibration with certified weights and performance checks
- Keeping the balance in direct sunlight
Correct Answer: Regular calibration with certified weights and performance checks
Q11. What does PQ (Performance Qualification) evaluate in equipment qualification?
- That equipment is purchased at the lowest cost
- That equipment performs consistently under simulated or production conditions
- That the equipment fits through the door
- That the equipment has correct branding stickers
Correct Answer: That equipment performs consistently under simulated or production conditions
Q12. Which utility system is critical for providing clean compressed air for pneumatic instruments and should be monitored in GLP labs?
- Fire suppression system
- Compressed air system with appropriate filtration and moisture control
- Telephone system
- Building elevator
Correct Answer: Compressed air system with appropriate filtration and moisture control
Q13. For GLP compliance, how should equipment maintenance and calibration records be stored?
- Verbally communicated only
- Only on personal notebooks
- Securely documented, dated, and retrievable for inspections
- Deleted after one week
Correct Answer: Securely documented, dated, and retrievable for inspections
Q14. Which environmental monitoring parameter is most critical for pharmaceutical stability studies?
- Indoor acoustic levels
- Temperature and relative humidity
- Wall paint color
- Number of windows
Correct Answer: Temperature and relative humidity
Q15. What is the role of SOPs (Standard Operating Procedures) regarding equipment use in a GLP lab?
- Provide informal tips only
- Define approved procedures, responsibilities, calibration intervals and acceptance criteria
- Serve as advertisements for equipment vendors
- Are optional suggestions for experienced staff
Correct Answer: Define approved procedures, responsibilities, calibration intervals and acceptance criteria
Q16. Which action ensures traceability of samples and results in a GLP facility?
- Using handwritten, unnumbered labels
- Implementing unique sample IDs, chain-of-custody records and linked documentation
- Mixing sample identifiers between studies
- Only recording results on scrap paper
Correct Answer: Implementing unique sample IDs, chain-of-custody records and linked documentation
Q17. Which instrument qualification document outlines the intended purpose and design criteria for new equipment?
- Performance Qualification (PQ)
- Installation Qualification (IQ)
- Design Qualification (DQ)
- Calibration Certificate
Correct Answer: Design Qualification (DQ)
Q18. What is a critical requirement for GLP cold storage units (freezers, refrigerators)?
- Keep door open to prevent frost
- Continuous temperature monitoring with alarms and documented calibration
- Store unrelated chemicals beside samples
- Unplug units during weekends
Correct Answer: Continuous temperature monitoring with alarms and documented calibration
Q19. In GLP, why is an instrument logbook important?
- To list favorite instruments of staff
- To document usage, maintenance, calibration and deviations for traceability
- To display instrument specifications publicly
- To keep track of lunch breaks
Correct Answer: To document usage, maintenance, calibration and deviations for traceability
Q20. Which waste management practice aligns with GLP principles?
- Merging chemical and biological waste without segregation
- Segregating, labeling, and disposing waste according to hazard class with records
- Dumping solvent waste down the sink
- Burning waste in open areas
Correct Answer: Segregating, labeling, and disposing waste according to hazard class with records
Q21. What is the recommended approach for instrument software used to acquire GLP data?
- No documentation is required for software
- Use validated software with access controls, audit trails and backup procedures
- Install any free software without qualification
- Disable audit trails to improve performance
Correct Answer: Use validated software with access controls, audit trails and backup procedures
Q22. Which competency is most important for GLP equipment operators?
- Ability to clean glassware quickly
- Training on SOPs, instrument operation, calibration and safety procedures
- Ability to work without supervision forever
- Familiarity with social media
Correct Answer: Training on SOPs, instrument operation, calibration and safety procedures
Q23. What must be verified during Operational Qualification (OQ) for an autoclave?
- That it has the company logo
- Temperature, pressure, time parameters and control functions operate within specified limits
- That it is located in the manager’s office
- That it requires manual monitoring only
Correct Answer: Temperature, pressure, time parameters and control functions operate within specified limits
Q24. How often should critical analytical instruments typically be calibrated under GLP?
- Only once at installation
- At defined intervals based on risk, manufacturer recommendations and usage
- Whenever a staff member remembers
- Every decade
Correct Answer: At defined intervals based on risk, manufacturer recommendations and usage
Q25. Which of the following is a key element of equipment lifecycle management in GLP?
- Discarding instruments after one use
- Procurement, qualification, calibration, maintenance, decommissioning and documentation
- Ignoring manufacturer updates
- Using equipment without manufacturer manuals
Correct Answer: Procurement, qualification, calibration, maintenance, decommissioning and documentation
Q26. What is the purpose of system suitability tests before sample analysis on HPLC?
- To increase run time purposely
- To verify system performance (e.g., resolution, theoretical plates) before analysis
- To change mobile phase composition randomly
- To avoid using calibration standards
Correct Answer: To verify system performance (e.g., resolution, theoretical plates) before analysis
Q27. In GLP, what is required when relocating a critical instrument to a new room?
- Just unplug and move it without records
- Repeat installation and operational qualification and document environmental conditions
- Move it during an inspection to save time
- Change its serial number
Correct Answer: Repeat installation and operational qualification and document environmental conditions
Q28. Which indicator demonstrates that routine preventive maintenance is effective for GLP equipment?
- Frequent unexplained instrument failures
- Reduced downtime, consistent performance and documented maintenance records
- Maintenance records stored on sticky notes only
- Maintenance performed only after catastrophic failures
Correct Answer: Reduced downtime, consistent performance and documented maintenance records
Q29. What is essential when introducing a new analytical method requiring specialized equipment in a GLP lab?
- Start without validation to save time
- Perform method validation, instrument qualification, and train staff with documented SOPs
- Only read the abstract of the method paper
- Use the instrument for other purposes immediately
Correct Answer: Perform method validation, instrument qualification, and train staff with documented SOPs
Q30. Which record retention practice aligns with regulatory expectations for GLP data and equipment records?
- Delete records after one month
- Retain records for defined retention periods, securely and retrievably, per regulations
- Store records only on a single personal computer
- Keep records in unlocked cabinets with no indexing
Correct Answer: Retain records for defined retention periods, securely and retrievably, per regulations
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.
Mail- Sachin@pharmacyfreak.com