Operational qualification (OQ) MCQs With Answer

Operational qualification (OQ) MCQs With Answer

by

Introduction

Operational Qualification (OQ) is a critical phase in pharmaceutical validation that confirms equipment and systems perform according to established operational limits under anticipated conditions. For M.Pharm students, mastering OQ principles is essential for ensuring product quality, patient safety, and regulatory compliance. This blog provides targeted OQ multiple-choice questions with answers to reinforce understanding of testing protocols, acceptance criteria, instrumentation, control systems, alarm functions, and documentation requirements. Questions are designed to probe both concepts and practical applications—such as worst-case selection, calibration dependency, computerized system checks, and requalification triggers—preparing students for academic exams and real-world validation responsibilities.

Q1. What is the primary objective of Operational Qualification (OQ) in pharmaceutical validation?

  • To ensure that the equipment is installed correctly
  • To verify that equipment operates within predetermined limits under normal operational conditions
  • To demonstrate consistent product quality over several production batches
  • To validate analytical testing methods used in QC

Correct Answer: To verify that equipment operates within predetermined limits under normal operational conditions

Q2. Which of the following is typically performed during OQ rather than IQ?

  • Verification of utility connections and mechanical installation
  • Calibration of instruments used for process control
  • Functional testing of control logic, alarms, and interlocks
  • Receipt inspection of components and spare parts

Correct Answer: Functional testing of control logic, alarms, and interlocks

Q3. When establishing OQ acceptance criteria for a temperature-controlled dryer, which approach is most appropriate?

  • Set acceptance limits to the equipment manufacturer’s maximum capability
  • Use historical production data only
  • Define acceptance limits based on process requirements and product stability data
  • Adopt default regulatory ranges without risk assessment

Correct Answer: Define acceptance limits based on process requirements and product stability data

Q4. During OQ of a lyophilizer, which test best demonstrates uniformity across product shelves?

  • Verification of vacuum pump motor specifications
  • Temperature mapping using calibrated thermocouples at multiple shelf locations
  • Visual inspection of shelf coatings
  • Measurement of shelf dimensions

Correct Answer: Temperature mapping using calibrated thermocouples at multiple shelf locations

Q5. Which document defines the stepwise tests and acceptance criteria to be executed during OQ?

  • Installation Qualification (IQ) Protocol
  • OQ Protocol (Operational Qualification Protocol)
  • Standard Operating Procedure (SOP) for cleaning
  • Batch Manufacturing Record (BMR)

Correct Answer: OQ Protocol (Operational Qualification Protocol)

Q6. In computerized system validation during OQ, an important test is to check for:

  • Physical footprint of the computer hardware
  • User training records only
  • Alarm generation, data integrity, user access controls, and audit trails
  • Compatibility of office software with the system

Correct Answer: Alarm generation, data integrity, user access controls, and audit trails

Q7. What is meant by “worst-case” conditions in OQ planning?

  • Testing only at mid-range setpoints
  • Selecting conditions most likely to challenge system performance and affect product quality
  • Testing at conditions outside equipment manufacturer’s limits
  • Performing tests only under ideal conditions

Correct Answer: Selecting conditions most likely to challenge system performance and affect product quality

Q8. Which of the following is a valid reason to perform requalification (including OQ elements) of equipment?

  • Change in building paint color
  • Minor cosmetic damage not affecting function
  • Major change in process parameters or manufacturing scope
  • Routine staff turnover

Correct Answer: Major change in process parameters or manufacturing scope

Q9. Acceptance criteria for automated control loops during OQ should be based on:

  • Manufacturer’s default PID settings only
  • Process capability, control requirements, and product tolerance limits
  • Randomly chosen values to test system flexibility
  • Historical weather data

Correct Answer: Process capability, control requirements, and product tolerance limits

Q10. Which sampling plan is most appropriate during OQ testing of multiple sensors in a critical system?

  • Test a single sensor and assume others are identical
  • Test a risk-based representative sample and include worst-case locations
  • Never test sensors because they were certified at factory
  • Test all non-critical sensors only

Correct Answer: Test a risk-based representative sample and include worst-case locations

Q11. What is the role of calibration during OQ activities?

  • Calibration is irrelevant to OQ
  • Ensure measuring instruments are traceable and within accuracy limits required for OQ tests
  • Calibration replaces the need for functional testing
  • Calibration is only recorded in IQ

Correct Answer: Ensure measuring instruments are traceable and within accuracy limits required for OQ tests

Q12. During OQ of HVAC for a cleanroom, which parameter is commonly challenged and verified?

  • Color of ceiling tiles
  • Air change rate, pressure differentials, and particle counts under dynamic conditions
  • Type of flooring adhesive
  • Brand of light fixtures

Correct Answer: Air change rate, pressure differentials, and particle counts under dynamic conditions

Q13. Why are alarm setpoints and responses tested during OQ?

  • To ensure the alarm lamps are bright
  • To verify timely detection, notification, and correct interlock actions to protect product and process
  • To check energy consumption during alarms
  • To confirm operator preferences for alarm tones

Correct Answer: To verify timely detection, notification, and correct interlock actions to protect product and process

Q14. Which of the following best describes the relationship between OQ and Process Qualification (PQ)?

  • OQ and PQ are identical activities with different names
  • OQ verifies equipment operation; PQ demonstrates consistent product quality during normal production
  • PQ is performed before OQ
  • OQ is only paperwork and not required if PQ is done

Correct Answer: OQ verifies equipment operation; PQ demonstrates consistent product quality during normal production

Q15. When documenting OQ test results, which practice is essential?

  • Record results in a temporary notebook without signatures
  • Keep only pass/fail summary without raw data
  • Record raw data, environmental conditions, instrument calibration status, deviations, and approvals
  • Use undocumented verbal confirmation from operators

Correct Answer: Record raw data, environmental conditions, instrument calibration status, deviations, and approvals

Q16. For a tablet compression machine, an important OQ test is to verify:

  • Operator hand size compatibility with equipment
  • Tablet weight uniformity and force control across the operational range
  • Color of lubricant labels
  • Delivery time of spare parts

Correct Answer: Tablet weight uniformity and force control across the operational range

Q17. If an OQ test fails, the appropriate immediate action is to:

  • Ignore the failure and proceed to PQ
  • Document the deviation, perform root cause analysis, implement corrective actions, and re-test
  • Change acceptance criteria to meet the test result
  • Blame the operator without investigation

Correct Answer: Document the deviation, perform root cause analysis, implement corrective actions, and re-test

Q18. Which of the following is true about concurrent testing during OQ?

  • Concurrent testing means performing OQ and routine production simultaneously without controls
  • Concurrent testing can be used when validated procedures allow OQ tests to be integrated into controlled production runs with pre-approved precautions
  • Concurrent testing is always prohibited
  • Concurrent testing replaces the need for documented protocols

Correct Answer: Concurrent testing can be used when validated procedures allow OQ tests to be integrated into controlled production runs with pre-approved precautions

Q19. How should OQ address software updates in a control system?

  • Software updates never affect OQ
  • Assess impact via change control and re-execute relevant OQ tests if functionality or controls are affected
  • Automatically accept updates without testing
  • Only verify hardware after software updates

Correct Answer: Assess impact via change control and re-execute relevant OQ tests if functionality or controls are affected

Q20. Which risk-based approach is most consistent with modern OQ planning?

  • Test everything exhaustively regardless of criticality
  • Prioritize OQ tests on equipment and parameters that most affect product quality and patient safety
  • Focus tests only on cosmetic and non-critical items
  • Perform OQ only when inspectors are present

Correct Answer: Prioritize OQ tests on equipment and parameters that most affect product quality and patient safety

Leave a Comment