MCQ Of Installation Qualification (IQ) » Flair Pharma The Knowledge Kit.

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#1. What is the main goal of Installation Qualification?

a) To operate equipment

b) To install utilities

c) To verify proper installation

d) To dismantle equipment

#2. Which document is essential for IQ execution?

a) User Requirements Specification (URS)

b) IQ Protocol

c) SOPs

d) Risk Assessment

#3. IQ should be completed:

a) After performance qualification

b) Before operational qualification

c) During cleaning validation

d) After equipment maintenance

#4. IQ confirms which of the following?

a) Operational performance

b) Installation accuracy

c) Product quality

d) Training effectiveness

#5. Which items are typically verified during IQ?

a) Equipment model and serial number

b) Staff qualifications

c) Market price of equipment

d) Training certificates

#6. What type of drawings are essential for IQ?

a) Electrical blueprints

b) As-built drawings

c) Site maps

d) Risk charts

#7. What is NOT commonly checked during IQ?

a) Installation manuals

b) Spare parts list

c) Utility connections

d) Vendor pricing

#8. In the V-Model, IQ corresponds to which phase?

a) Design phase

b) Verification phase

c) Maintenance phase

d) Marketing phase

#9. Who is responsible for reviewing IQ protocols?

a) IT support

b) Production operators

c) Validation team

d) Cleaning team

#10. When an instrument is installed, what must be verified?

a) Year of manufacture

b) Make and Model

c) Warranty duration

d) Vendor's turnover

#11. IQ ensures installation is consistent with:

a) Marketing strategies

b) Good Manufacturing Practices (GMP)

c) Customer feedback

d) Training needs

#12. IQ checks system security features. (True/False)

a) True

b) False

c) Sometimes

d) Rarely

#13. What is not part of IQ records?

a) Equipment manuals

b) Utility connection diagrams

c) Calibration certificates

d) Purchase orders

#14. Which section lists required spare parts in IQ?

a) Deviations section

b) Spare parts list section

c) Training log

d) Validation timeline

#15. In a risk-based approach, IQ focuses on:

a) Low-cost systems

b) Non-impact systems

c) Critical systems

d) Marketing systems

#16. Which document verifies equipment acceptance during installation?

a) Risk analysis report

b) Training summary

c) Site Acceptance Test (SAT)

d) Safety audit

#17. What must happen if an IQ deviation occurs?

a) Ignore it

b) Implement a CAPA

c) Cancel the IQ

d) Inform marketing

#18. IQ is documented proof that __________ is installed correctly.

a) Software

b) Facility equipment

c) Raw material

d) Personnel

#19. IQ is not needed if equipment was previously qualified. (True/False)

a) True

b) False

c) Depends on QA

d) Only if validated

#20. Who must approve IQ completion?

a) Finance Manager

b) Quality Assurance

c) Vendor

d) Warehouse Manager

#21. IQ must comply with which regulation?

a) OSHA Act

b) 21 CFR Part 210/211

c) ISO 9001

d) 21 CFR Part 11

#22. What is the first action in IQ?

a) Calibration

b) Documentation verification

c) Performance test

d) Data integrity check

#23. Q is typically associated with:

a) Routine calibration

b) Equipment relocation or new installation

c) Annual audit

d) Cleaning validation

#24. What must be attached to the IQ protocol?

a) Vendor’s tax invoice

b) Equipment installation photographs

c) Employee listx

d) Audit checklist

#25. Which should NOT be installed during IQ unless verified?

a) Calibration labels

b) Nameplates

c) Additional software patches

d) Utility lines

#26. If a calibration certificate is missing during IQ, what should you do?

a) Proceed without it

b) Issue a deviation report

c) Inform Marketing

d) Shut down the facility

#27. IQ activities can be outsourced to vendors. (True/False)

a) True

b) False

c) Only sometimes

d) Never

#28. What indicates a successful IQ?

a) Minor system errors

b) Full documentation compliance

c) Equipment downtime

d) Product failure

#29. What labels are checked during IQ?

a) Vendor address labels

b) Identification and Safety labels

c) Product barcodes

d) Software security labels

#30. What is the final step in IQ?

a) Operational Qualification (OQ)

b) Preventive Maintenance

c) IQ Summary Report completion

d) Cleaning validation

#31. IQ verifies __________ integrity.

a) Product

b) Installation

c) Environmental

d) User

#32. Which tool verifies torque during IQ?

a) Hygrometer

b) Pressure gauge

c) Torque wrench

d) Thermometer

#33. What is a key input for preparing IQ?

a) Environmental Monitoring Plan

b) Annual Product Review

c) Validation Master Plan (VMP)

d) Marketing Approval

#34. Which must be cross-verified during IQ?

a) Serial and model numbers

b) Employee IDs

c) Product expiry dates

d) Vendor payment records

#35. Who signs off on IQ completion?

a) Equipment vendor

b) Warehouse Supervisor

c) Quality and Validation Heads

d) Finance Department

#36. IQ may include verifying which of the following?

a) Staff salaries

b) Environmental conditions

c) Equipment serial numbersv

d) Utility capacities

#37. Which deviation must be recorded during IQ?

a) Typographical errorx

b) Missing part installation

c) SOP title spelling mistake

d) Staff signature missing

#38. If utilities don’t match specifications, you must:

a) Proceed anyway

b) Document deviation and correct

c) Inform Marketing

d) Cancel the IQ

#39. What is typically OUT of IQ scope?

a) Correct equipment installation

b) Software backup

c) Equipment location verification

d) Calibration certificate review

Finish

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Results

#1. What is the main goal of Installation Qualification?

#2. Which document is essential for IQ execution?

#3. IQ should be completed:

#4. IQ confirms which of the following?

#5. Which items are typically verified during IQ?

#6. What type of drawings are essential for IQ?

#7. What is NOT commonly checked during IQ?

#8. In the V-Model, IQ corresponds to which phase?

#9. Who is responsible for reviewing IQ protocols?

#10. When an instrument is installed, what must be verified?

#11. IQ ensures installation is consistent with:

#12. IQ checks system security features. (True/False)

#13. What is not part of IQ records?

#14. Which section lists required spare parts in IQ?

#15. In a risk-based approach, IQ focuses on:

#16. Which document verifies equipment acceptance during installation?

#17. What must happen if an IQ deviation occurs?

#18. IQ is documented proof that __________ is installed correctly.

#19. IQ is not needed if equipment was previously qualified. (True/False)

#20. Who must approve IQ completion?

#21. IQ must comply with which regulation?

#22. What is the first action in IQ?

#23. Q is typically associated with:

#24. What must be attached to the IQ protocol?

#25. Which should NOT be installed during IQ unless verified?

#26. If a calibration certificate is missing during IQ, what should you do?

#27. IQ activities can be outsourced to vendors. (True/False)

#28. What indicates a successful IQ?

#29. What labels are checked during IQ?

#30. What is the final step in IQ?

#31. IQ verifies __________ integrity.

#32. Which tool verifies torque during IQ?

#33. What is a key input for preparing IQ?

#34. Which must be cross-verified during IQ?

#35. Who signs off on IQ completion?

#36. IQ may include verifying which of the following?

#37. Which deviation must be recorded during IQ?

#38. If utilities don’t match specifications, you must:

#39. What is typically OUT of IQ scope?

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