Introduction: Equipment selection, qualification and maintenance are core topics in pharmaceutical manufacturing that ensure product quality, safety and regulatory compliance. For B.Pharm students, understanding equipment selection criteria—capacity, material of construction, utility needs, risk and supplier qualifications—is essential. Qualification phases (Design, Installation, Operational and Performance Qualification), calibration, preventive and corrective maintenance, validation lifecycle, GMP documentation and SOPs form the backbone of a robust quality system. Key keywords: equipment selection, equipment qualification, calibration, preventive maintenance, validation, GMP, PQ, IQ, OQ, reliability and traceability. Practical knowledge of these concepts helps reduce deviations, ensure reproducibility and support regulatory inspections. ‘Now let’s test your knowledge with 30 MCQs on this topic.’
Q1. What is the primary purpose of Equipment Qualification in a pharmaceutical facility?
- To design the production process
- To demonstrate that equipment operates within predetermined limits and consistently produces acceptable results
- To reduce the purchase cost of equipment
- To train operators on production techniques
Correct Answer: To demonstrate that equipment operates within predetermined limits and consistently produces acceptable results
Q2. Which sequence correctly represents common qualification phases?
- IQ, OQ, PQ
- PQ, OQ, IQ
- OQ, IQ, PQ
- Design, Calibration, Operation
Correct Answer: IQ, OQ, PQ
Q3. What does IQ (Installation Qualification) primarily verify?
- That equipment design meets user needs
- That equipment is installed according to manufacturer and engineering specifications
- That production yields meet specification
- That cleaning procedures are effective
Correct Answer: That equipment is installed according to manufacturer and engineering specifications
Q4. During OQ (Operational Qualification), what is typically assessed?
- Installation clearances and foundation bolts
- Basic equipment functionality under simulated operating conditions and operational limits
- Long-term product stability
- Market acceptability of products
Correct Answer: Basic equipment functionality under simulated operating conditions and operational limits
Q5. Performance Qualification (PQ) focuses on:
- Design approval from vendors
- Demonstrating consistent performance using actual product and process parameters
- Supplier audits
- Routine calibration schedule
Correct Answer: Demonstrating consistent performance using actual product and process parameters
Q6. Which document is essential to record acceptance criteria, test procedures and results for each qualification stage?
- Design History File
- Qualification Protocol
- Batch Production Record only
- Purchase Order
Correct Answer: Qualification Protocol
Q7. What is the purpose of Factory Acceptance Test (FAT)?
- To test equipment at the supplier’s site before shipping
- To qualify operators after installation
- To verify batch records
- To do routine maintenance
Correct Answer: To test equipment at the supplier’s site before shipping
Q8. Which is a key criterion when selecting pharmaceutical equipment material of construction?
- Color of paint
- Chemical compatibility, cleanability and corrosion resistance
- Country of manufacture only
- Number of electrical outlets
Correct Answer: Chemical compatibility, cleanability and corrosion resistance
Q9. Calibration primarily ensures:
- Operators follow SOPs
- Measurement instruments provide results traceable to national or international standards
- Equipment is installed correctly
- Spares are available
Correct Answer: Measurement instruments provide results traceable to national or international standards
Q10. Which term describes the documented evidence that a system or equipment will consistently perform as intended throughout its life?
- Qualification Certificate
- Validation Lifecycle
- Purchase Requisition
- Operator Manual
Correct Answer: Validation Lifecycle
Q11. Risk-based maintenance planning means:
- Maintaining only the cheapest equipment
- Prioritizing maintenance based on risk to product quality, patient safety and business continuity
- Performing maintenance only after failures occur
- Recalibrating every instrument monthly regardless of risk
Correct Answer: Prioritizing maintenance based on risk to product quality, patient safety and business continuity
Q12. Which of the following is NOT typically part of preventive maintenance?
- Scheduled lubrication and inspection
- Replacing wear parts at planned intervals
- Waiting until equipment fails to repair it
- Cleaning and adjustment per SOP
Correct Answer: Waiting until equipment fails to repair it
Q13. Traceability in calibration means:
- Following the manufacturer’s logo
- Linking measurement results to national or international reference standards through an unbroken chain of comparisons
- Documenting operator names
- Using only in-house standards
Correct Answer: Linking measurement results to national or international reference standards through an unbroken chain of comparisons
Q14. Which of the following is a key element of a calibration certificate?
- Operator’s favorite color
- Uncertainty of measurement, reference standard and date of calibration
- Purchase price of instrument
- Warranty duration only
Correct Answer: Uncertainty of measurement, reference standard and date of calibration
Q15. What triggers requalification of equipment?
- Change in process, major maintenance, relocation or after a critical deviation
- Only the annual calendar date
- When the operator requests it for convenience
- Never required once initial qualification is done
Correct Answer: Change in process, major maintenance, relocation or after a critical deviation
Q16. Which maintenance metric indicates the average time between failures?
- MTTR (Mean Time to Repair)
- MTBF (Mean Time Between Failures)
- OEE (Overall Equipment Effectiveness)
- FAT (Factory Acceptance Test)
Correct Answer: MTBF (Mean Time Between Failures)
Q17. For computerized systems used in GMP processes, what guideline addresses their validation?
- GAMP (Good Automated Manufacturing Practice)
- FAT only
- ISO 9000 exclusively
- FDA 510(k)
Correct Answer: GAMP (Good Automated Manufacturing Practice)
Q18. Which is a correct statement about Design Qualification (DQ)?
- DQ is performed after PQ
- DQ documents that design meets user and regulatory requirements before procurement
- DQ focuses only on calibration
- DQ is optional and not related to user requirements
Correct Answer: DQ documents that design meets user and regulatory requirements before procurement
Q19. Temperature mapping is most important for qualifying which equipment?
- Centrifuges
- Cold rooms, refrigerators and pass-through chambers
- Tablet presses
- Pallet racks
Correct Answer: Cold rooms, refrigerators and pass-through chambers
Q20. What is the difference between validation and qualification?
- There is no difference; terms are interchangeable
- Qualification demonstrates equipment fitness; validation demonstrates that processes consistently produce desired results
- Validation only applies to buildings
- Qualification focuses on marketing approval
Correct Answer: Qualification demonstrates equipment fitness; validation demonstrates that processes consistently produce desired results
Q21. Which approach helps determine critical equipment requiring tighter maintenance and calibration?
- Random selection
- Risk assessment based on impact to product quality and patient safety
- Shortest maintenance interval first
- Only equipment older than five years
Correct Answer: Risk assessment based on impact to product quality and patient safety
Q22. A critical parameter during OQ for a tablet coating machine would be:
- Color of the operator’s uniform
- Spray rate, pan speed and inlet/outlet temperatures within specified limits
- Total number of operators trained worldwide
- Shipping schedule of the equipment
Correct Answer: Spray rate, pan speed and inlet/outlet temperatures within specified limits
Q23. Which practice ensures calibration equipment remains reliable over time?
- Ignoring calibration records
- Using calibrated reference standards and following scheduled recalibration with traceability
- Calibrating only when a deviation is detected
- Replacing instruments every month
Correct Answer: Using calibrated reference standards and following scheduled recalibration with traceability
Q24. What is the role of SOPs in equipment maintenance and qualification?
- They are optional suggestions
- They provide standardized procedures for operation, maintenance, calibration and qualification to ensure compliance
- They replace calibration certificates
- They are used only for training new hires
Correct Answer: They provide standardized procedures for operation, maintenance, calibration and qualification to ensure compliance
Q25. Which documentation is retained as evidence that maintenance activities were performed?
- Maintenance logs, work orders and updated calibration certificates
- Only verbal confirmation
- Purchase order copies only
- Vendor brochures
Correct Answer: Maintenance logs, work orders and updated calibration certificates
Q26. When selecting a vendor for critical equipment, which factor is least relevant?
- Vendor’s experience with pharmaceutical installations
- Availability of service and spare parts
- Vendor’s proximity to manufacturing site
- Color of vendor’s corporate logo
Correct Answer: Color of vendor’s corporate logo
Q27. Which activity is part of Operational Qualification for a HPLC system?
- Verifying column packing at supplier factory only
- Checking pump flow stability, detector linearity and autosampler precision under defined conditions
- Only updating software without tests
- Repainting the instrument exterior
Correct Answer: Checking pump flow stability, detector linearity and autosampler precision under defined conditions
Q28. Corrective maintenance is best described as:
- Planned replacement of wear parts
- Unplanned repair actions taken after equipment failure to restore functionality
- Calibration performed at scheduled intervals
- Routine cleaning only
Correct Answer: Unplanned repair actions taken after equipment failure to restore functionality
Q29. Which metric helps evaluate how effectively equipment is used in production?
- MTTR only
- OEE (Overall Equipment Effectiveness)
- Calibration certificate number
- Vendor’s delivery time
Correct Answer: OEE (Overall Equipment Effectiveness)
Q30. Why is documentation of environmental conditions during PQ important?
- Environmental data are irrelevant for PQ
- Because temperature, humidity and other conditions can affect process performance and product quality, so documented evidence supports acceptance
- Only to satisfy vendor requirements
- To increase paperwork volume
Correct Answer: Because temperature, humidity and other conditions can affect process performance and product quality, so documented evidence supports acceptance
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