Equipment Qualification – IQ MCQs With Answer

Introduction: Equipment Qualification – IQ MCQs With Answer is designed for M.Pharm students preparing for exams and industry roles in Scale Up & Technology Transfer. This short quiz-focused blog emphasizes Installation Qualification (IQ) — the documented verification that equipment, systems and subsystems are installed per design, manufacturer’s specifications, and applicable regulatory requirements. The questions probe deeper than simple definitions: they cover required documentation, acceptance criteria, utility connections, instrument calibration, responsibilities, interfaces with OQ/PQ, and change control implications. Working through these MCQs will reinforce practical understanding of IQ practices, critical checks during site installation, and how IQ supports robust technology transfer and GMP compliance.

Q1. What is the primary objective of Installation Qualification (IQ) in equipment qualification?

• To validate the performance of the equipment under process conditions
• To verify and document that equipment and utilities are installed according to design and manufacturer’s specifications
• To train operators on using the equipment
• To establish cleaning procedures for the equipment

Correct Answer: To verify and document that equipment and utilities are installed according to design and manufacturer’s specifications

Q2. Which of the following documents is typically created during the IQ phase?

• Protocol for product stability studies
• Installation Qualification (IQ) Protocol and Installation Checklist
• Cleaning Validation Protocol
• Process validation final report

Correct Answer: Installation Qualification (IQ) Protocol and Installation Checklist

Q3. Which party is primarily responsible for preparing the IQ protocol in a typical technology transfer scenario?

• Regulatory authority
• Quality Assurance (QA) of the receiving facility, often with vendor input
• Third-party auditors exclusively
• Production operators only

Correct Answer: Quality Assurance (QA) of the receiving facility, often with vendor input

Q4. During IQ, which of the following is NOT typically verified?

• Correct model and serial numbers as per purchase order
• Presence of required utilities (electrical, steam, compressed air) at specified points
• Performance of the equipment at maximum load over several runs
• Availability of spare parts and recommended tools

Correct Answer: Performance of the equipment at maximum load over several runs

Q5. Which of the following best distinguishes IQ from OQ?

• IQ checks supplier credentials; OQ verifies cleaning procedures
• IQ documents installation and configuration; OQ tests operational functionality under defined conditions
• IQ is performed after OQ; OQ is done before shipment
• IQ is concerned only with software; OQ is for hardware

Correct Answer: IQ documents installation and configuration; OQ tests operational functionality under defined conditions

Q6. Which acceptance criterion is most relevant during IQ for utility connections?

• Operator preference for utility layout
• Utilities are present, labeled, and meet specified pressure, flow, and quality at connection points
• Cost of utilities over one year
• Environmental sustainability score

Correct Answer: Utilities are present, labeled, and meet specified pressure, flow, and quality at connection points

Q7. What evidence is typically required to show that instrumentation used during IQ is reliable?

• Verbal confirmation from a technician
• Calibration certificates and traceability to national standards
• Invoice for the instrument purchase
• Vendor marketing brochure

Correct Answer: Calibration certificates and traceability to national standards

Q8. Which of the following items is commonly included in an IQ report?

• Batch yield comparison across campaigns
• As‑installed drawings, serial numbers, utility line diagrams, and deviations observed during installation
• Marketing strategy for the new product
• Detailed stability data for the active ingredient

Correct Answer: As‑installed drawings, serial numbers, utility line diagrams, and deviations observed during installation

Q9. If a piece of equipment is moved to a different room after IQ is complete, what is the appropriate action?

• No further action is needed if the equipment turns on
• Perform a re‑IQ to verify installation at the new location and assess impact on utilities and environment
• Only update the asset register without further checks
• Immediately perform full PQ only

Correct Answer: Perform a re‑IQ to verify installation at the new location and assess impact on utilities and environment

Q10. Which risk-based approach can be applied when deciding the extent of IQ activities?

• Apply identical IQ tests to all equipment regardless of criticality
• Use a risk assessment (e.g., FMEA) to focus IQ effort on critical items that affect product quality and safety
• Defer all risk evaluation to PQ phase
• Only inspect cosmetic aspects of equipment

Correct Answer: Use a risk assessment (e.g., FMEA) to focus IQ effort on critical items that affect product quality and safety

Q11. Which statement about Software and PLCs during IQ is correct?

• Software verification is not part of IQ and can be ignored until PQ
• IQ should document installed software/firmware versions, licenses, backups, and access controls before OQ
• Only hardware serial numbers are relevant; software details are never recorded
• Software should be overwritten frequently to avoid version control

Correct Answer: IQ should document installed software/firmware versions, licenses, backups, and access controls before OQ

Q12. When should vendor documentation such as manuals and wiring diagrams be collected in relation to IQ?

• After PQ is completed
• Prior to or during IQ so installation can be verified against manufacturer instructions
• Only if regulatory inspectors request them
• Only at equipment decommissioning

Correct Answer: Prior to or during IQ so installation can be verified against manufacturer instructions

Q13. Which of the following is an example of an IQ acceptance criterion for a compressed air connection?

• Air color matches factory standard
• Outlet pressure and dew point meet specified values and appropriate filtration is in place
• Compressed air costs are within budget
• Operators prefer the location of the outlet

Correct Answer: Outlet pressure and dew point meet specified values and appropriate filtration is in place

Q14. What is the role of calibration status during IQ?

• Calibration is irrelevant for IQ
• Verify that critical measuring instruments are calibrated, with valid calibration certificates and due dates recorded
• Only new instruments require calibration
• Calibration should be deferred to routine maintenance

Correct Answer: Verify that critical measuring instruments are calibrated, with valid calibration certificates and due dates recorded

Q15. Which of the following triggers a requirement for partial or full requalification including IQ?

• Minor changes in production schedule only
• Relocation, major modification, or change in utility supply that impacts installation specifications
• Routine cleaning operations
• Change of operator clothing color

Correct Answer: Relocation, major modification, or change in utility supply that impacts installation specifications

Q16. How should deviations discovered during IQ be handled?

• Ignored if the equipment powers up
• Documented, investigated for impact on quality/safety, dispositioned, and approved by QA before continuing
• Fixed without documentation to save time
• Reported only after PQ completion

Correct Answer: Documented, investigated for impact on quality/safety, dispositioned, and approved by QA before continuing

Q17. Which of these is a correct statement about labeling and identification in IQ?

• Labeling of equipment is cosmetic and optional
• Equipment should be uniquely identified by tag numbers, with labels for utilities and safety information per IQ requirements
• Only software needs unique identification
• Labeling is postponed until after PQ

Correct Answer: Equipment should be uniquely identified by tag numbers, with labels for utilities and safety information per IQ requirements

Q18. In IQ for a steam-sterilized autoclave, which item is most likely to be verified?

• Taste of product after sterilization
• Proper steam supply, condensate drainage, safety valves, pressure gauges, and steam trap installation per specification
• Operator eye color
• Marketing claims about sterilization speed

Correct Answer: Proper steam supply, condensate drainage, safety valves, pressure gauges, and steam trap installation per specification

Q19. Which of the following best describes the relationship between Design Qualification (DQ) and IQ?

• DQ is performed after IQ
• DQ documents that the design meets GMP requirements; IQ verifies the design has been implemented correctly at the site
• DQ is only financial documentation
• IQ replaces the need for DQ

Correct Answer: DQ documents that the design meets GMP requirements; IQ verifies the design has been implemented correctly at the site

Q20. Which of the following is an important record retention practice related to IQ?

• Discard IQ records after one month to save space
• Maintain IQ protocols, raw data, calibration certificates, and final IQ reports in retained quality records per company policy and regulatory expectations
• Keep only a summary memo without supporting data
• Store IQ records only electronically without backup

Correct Answer: Maintain IQ protocols, raw data, calibration certificates, and final IQ reports in retained quality records per company policy and regulatory expectations

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