Installation qualification (IQ) MCQs With Answer

Installation Qualification (IQ) MCQs With Answer

This quiz set on Installation Qualification (IQ) is designed specifically for M.Pharm students studying Pharmaceutical Validation. It focuses on the principles, documentation, procedures and regulatory expectations involved in IQ of equipment, utilities and systems used in pharmaceutical production and laboratories. Questions emphasize practical aspects such as design review, vendor documentation, utilities connections, calibration prerequisites, acceptance criteria, and traceability requirements. The aim is to reinforce understanding of how IQ fits into the overall DQ/IQ/OQ/PQ lifecycle, how to interpret and prepare IQ protocols and reports, and how to apply risk-based thinking to ensure compliant and reliable installations.

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

• To verify that equipment and systems operate within specified limits under load conditions
• To ensure the installed system meets design and manufacturer specifications and is correctly installed
• To validate the final product meets quality specifications
• To perform routine preventive maintenance

Correct Answer: To ensure the installed system meets design and manufacturer specifications and is correctly installed

Q2. Which document is typically produced before executing IQ to describe tests, checks and acceptance criteria?

• Operational Qualification Protocol (OQ)
• Installation Qualification Protocol (IQ)
• Standard Operating Procedure (SOP)
• Performance Verification Checklist

Correct Answer: Installation Qualification Protocol (IQ)

Q3. Which of the following is NOT usually part of IQ activities?

• Verification of utility connections and capacities
• Confirmation of materials of construction and surface finishes
• Stress testing under full production load to prove long-term reliability
• Review and retention of manufacturer certificates and drawings

Correct Answer: Stress testing under full production load to prove long-term reliability

Q4. In the equipment qualification lifecycle, IQ most directly follows which stage?

• Performance Qualification (PQ)
• Design Qualification (DQ)
• Operational Qualification (OQ)
• Routine Calibration

Correct Answer: Design Qualification (DQ)

Q5. Which of these is a critical deliverable to be verified during IQ?

• Establishment of cleaning validation
• Verification of software functional requirements
• Verification of serial numbers, model, and version as per purchase order
• Long-term stability study results

Correct Answer: Verification of serial numbers, model, and version as per purchase order

Q6. During IQ, why is verification of utility supplies (electricity, water, gas) important?

• To ensure utilities are certified by the original manufacturer
• Because utilities determine the shelf-life of products
• To confirm correct supply type, pressure, flow, and quality needed for proper equipment operation
• To validate employee competency in using utilities

Correct Answer: To confirm correct supply type, pressure, flow, and quality needed for proper equipment operation

Q7. Which of the following best describes “as-built” drawings in the context of IQ?

• Design drawings produced before purchase
• Drawings that reflect the final installed configuration after modifications during installation
• Manufacturer promotional diagrams
• Generic schematic not linked to a specific installation

Correct Answer: Drawings that reflect the final installed configuration after modifications during installation

Q8. What role does calibration play in IQ?

• Calibration is irrelevant to IQ and only part of OQ
• Calibration confirms that measuring and control instruments are accurate before use in OQ/PQ
• Calibration is only performed after PQ is complete
• Calibration replaces the need for functional checks during IQ

Correct Answer: Calibration confirms that measuring and control instruments are accurate before use in OQ/PQ

Q9. Which of the following records is essential to document during IQ to ensure traceability?

• Batch manufacturing records for future production
• Certificates of conformity, material certificates and serial numbers
• Stability testing logs
• Employee training attendance sheets

Correct Answer: Certificates of conformity, material certificates and serial numbers

Q10. What is FAT and how is it related to IQ?

• Failure Acceptance Test; it replaces IQ activities on site
• Factory Acceptance Test; it is performed at vendor premises to reduce onsite IQ testing
• Final Authorization Test; it is performed after PQ for regulatory submission
• Functional Adjustment Test; it is an informal check by operators

Correct Answer: Factory Acceptance Test; it is performed at vendor premises to reduce onsite IQ testing

Q11. Which acceptance criterion would be most appropriate to include in IQ for equipment anchoring and leveling?

• Equipment should be painted within three days of installation
• Anchor bolts torque within specified values and equipment level within manufacturer tolerances
• Operator manual will be provided within five months
• All connections should be made of stainless steel

Correct Answer: Anchor bolts torque within specified values and equipment level within manufacturer tolerances

Q12. How should deviations discovered during IQ be handled?

• Ignore minor deviations and proceed to OQ
• Record deviations, perform risk assessment, and disposition by change control before continuing
• Document deviation only in the final PQ report
• Repair immediately without documentation

Correct Answer: Record deviations, perform risk assessment, and disposition by change control before continuing

Q13. Which of the following is a suitable acceptance criterion related to electrical supply during IQ?

• Ambient noise must be below 50 dB
• Power supply voltage and frequency should be within ±10% of equipment rating and proper earthing verified
• All cables must be black in color
• Equipment must be started and run continuously for 72 hours

Correct Answer: Power supply voltage and frequency should be within ±10% of equipment rating and proper earthing verified

Q14. Why is vendor documentation review important in IQ?

• Vendor documents are only for warranty claims and not for IQ
• To ensure equipment installation requirements, maintenance instructions and limits are understood and captured in IQ
• To set operator work schedules
• Because regulators require copies of all vendor marketing materials

Correct Answer: To ensure equipment installation requirements, maintenance instructions and limits are understood and captured in IQ

Q15. Which statement best describes the relationship between IQ and OQ?

• IQ proves performance under stress; OQ verifies installation details
• IQ documents correct installation; OQ demonstrates the system operates correctly across intended ranges
• IQ and OQ are interchangeable terms
• IQ is performed only for software and OQ only for hardware

Correct Answer: IQ documents correct installation; OQ demonstrates the system operates correctly across intended ranges

Q16. For computerized systems, which IQ activity is essential prior to functional testing?

• Performing final product release
• Verification of hardware/software versions, network configurations and secure backups of configuration files
• Writing new software code
• Only checking user access levels without documenting

Correct Answer: Verification of hardware/software versions, network configurations and secure backups of configuration files

Q17. When should an IQ be repeated or requalification be performed?

• Only when regulators visit the site
• After major changes, relocation, repairs, or when use conditions are significantly altered
• Never; IQ is a one-time activity
• Only if the equipment fails during production

Correct Answer: After major changes, relocation, repairs, or when use conditions are significantly altered

Q18. Which of the following best describes an IQ “traceability matrix”?

• A list of employees trained on the equipment
• A mapping showing how IQ checks link to design requirements, purchase order and acceptance criteria
• A timeline for preventive maintenance
• A record of all product batches run on the equipment

Correct Answer: A mapping showing how IQ checks link to design requirements, purchase order and acceptance criteria

Q19. What is the regulatory expectation regarding IQ documentation retention?

• IQ records may be discarded after one year
• IQ documentation should be maintained for a defined period per company policy and regulatory requirements, often aligned with product retention or lifetime of equipment
• Only IQ reports for sterile products need retention
• Retention is optional and up to the installation team

Correct Answer: IQ documentation should be maintained for a defined period per company policy and regulatory requirements, often aligned with product retention or lifetime of equipment

Q20. Which risk-based approach is most appropriate when prioritizing IQ activities?

• Focus only on cosmetic issues and ignore critical utilities
• Prioritize systems and components with highest potential to impact product quality, safety, or data integrity
• Test everything exhaustively regardless of impact
• Perform IQ activities only for the most expensive equipment

Correct Answer: Prioritize systems and components with highest potential to impact product quality, safety, or data integrity

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