Equipment Qualification – PQ MCQs With Answer

Equipment Qualification – PQ MCQs With Answer

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Equipment Qualification – PQ MCQs With Answer

Introduction: This quiz collection focuses on Performance Qualification (PQ) — a critical phase in equipment qualification during scale-up and technology transfer. Designed for M.Pharm students, the questions cover purpose, planning, execution, and documentation of PQ for pharmaceutical manufacturing equipment and utilities. Emphasis is placed on designing realistic PQ protocols, establishing acceptance criteria, worst‑case and load conditions, sampling plans, and the relationship of PQ with IQ/OQ, validation master plan and risk assessment. These MCQs will help students deepen conceptual understanding and application of PQ principles, preparing them for practical validation work and regulatory inspection expectations.

Q1. What is the primary objective of Performance Qualification (PQ) for pharmaceutical equipment?

  • To verify the manufacturer’s installation instructions
  • To demonstrate that the equipment consistently performs within predetermined limits under routine production conditions
  • To check electrical safety compliance
  • To ensure the equipment is cleaned after each use

Correct Answer: To demonstrate that the equipment consistently performs within predetermined limits under routine production conditions

Q2. Which of the following is a key element that must be defined in a PQ protocol?

  • Supplier’s full company profile
  • Acceptance criteria and test methods for critical performance attributes
  • The color of the equipment paint
  • Marketing strategy for the product made on the equipment

Correct Answer: Acceptance criteria and test methods for critical performance attributes

Q3. During PQ of a tablet press, which test would be most relevant?

  • Electrical insulation resistance test
  • Tablet weight variation and hardness across multiple production runs
  • Visual inspection of the factory exterior
  • Acoustic noise level in the control room

Correct Answer: Tablet weight variation and hardness across multiple production runs

Q4. Which approach best defines “worst‑case” conditions in PQ planning?

  • Selecting conditions that are easiest to achieve
  • Selecting extremes or combinations of process parameters that challenge product quality and equipment performance
  • Using the most commonly used operating setpoint only
  • Running the equipment at zero load

Correct Answer: Selecting extremes or combinations of process parameters that challenge product quality and equipment performance

Q5. How does PQ relate to IQ and OQ?

  • PQ replaces IQ and OQ and is performed first
  • PQ verifies consistent performance under operational conditions after IQ (installation) and OQ (operation) have been completed
  • PQ is only documentation of IQ and OQ results
  • PQ is unrelated and optional if IQ is complete

Correct Answer: PQ verifies consistent performance under operational conditions after IQ (installation) and OQ (operation) have been completed

Q6. Which statistical consideration is most relevant when designing a PQ sampling plan?

  • Sampling should always be one sample per batch regardless of batch size
  • Use of confidence intervals, sample size calculation and representative sampling to ensure power to detect nonconformance
  • Sampling based only on operator preference
  • Sampling only when equipment shows visible defects

Correct Answer: Use of confidence intervals, sample size calculation and representative sampling to ensure power to detect nonconformance

Q7. Which of the following activities is typically performed during PQ of an autoclave?

  • Airflow smoke visualization inside the building lobby
  • Biological and chemical indicator runs under full cycle load to confirm sterilization efficacy
  • Painting the autoclave exterior with heat-resistant paint
  • Measuring the conductivity of wash water

Correct Answer: Biological and chemical indicator runs under full cycle load to confirm sterilization efficacy

Q8. Which document normally defines who has authorization to approve PQ deviations?

  • Supplier invoice
  • Validation Master Plan (VMP) or PQ protocol with specified approvers and change control procedures
  • Standard operating procedure for marketing
  • Employee handbook

Correct Answer: Validation Master Plan (VMP) or PQ protocol with specified approvers and change control procedures

Q9. In PQ, what is the significance of “concurrent validation”?

  • It validates equipment without any production material
  • It involves performing validation activities during routine production for products where prospective validation was not feasible
  • It is the same as OQ
  • It only applies to non‑regulated industries

Correct Answer: It involves performing validation activities during routine production for products where prospective validation was not feasible

Q10. When requalifying equipment after maintenance, what approach is recommended?

  • Requalification scope should be based on risk assessment and extent of changes made
  • Always full PQ irrespective of maintenance type
  • Never requalify; rely on previous PQ forever
  • Only perform IQ again

Correct Answer: Requalification scope should be based on risk assessment and extent of changes made

Q11. What role does a temperature mapping study play in PQ for an environmental chamber?

  • Maps the electrical wiring layout
  • Establishes spatial and temporal temperature (and humidity) uniformity under loaded conditions to support acceptance criteria
  • Determines operator shift schedules
  • Measures noise generated by fans

Correct Answer: Establishes spatial and temporal temperature (and humidity) uniformity under loaded conditions to support acceptance criteria

Q12. Which of the following is an appropriate acceptance criterion for a PQ test?

  • Undefined, decided after test completion
  • Pre‑defined numeric limits based on product quality requirements and regulatory expectations
  • Any value within the manufacturing capacity
  • Targets based on competitor performance only

Correct Answer: Pre‑defined numeric limits based on product quality requirements and regulatory expectations

Q13. For validation of a sterile isolator, which PQ activity is essential?

  • Validation of the canteen food menu
  • Aseptic process simulation (media fills) to demonstrate maintenance of sterility during simulated production
  • Checking the weight of the isolator doors
  • Testing the color of gloves

Correct Answer: Aseptic process simulation (media fills) to demonstrate maintenance of sterility during simulated production

Q14. Which of these is a common cause for PQ failure that should be anticipated in the protocol?

  • Inappropriate acceptance criteria, inadequate sample size, or non‑representative test conditions
  • Too many personnel attending the PQ meeting
  • The brand of coffee in the break room
  • Presence of too many spare parts in inventory

Correct Answer: Inappropriate acceptance criteria, inadequate sample size, or non‑representative test conditions

Q15. How should computerized system controls on manufacturing equipment be addressed during PQ?

  • Ignore computerized controls during PQ
  • Ensure the computerized system is validated (CSV) and that control logic and alarms function within PQ acceptance criteria
  • Only validate hardware, not software
  • Rely solely on vendor’s demonstration without documented testing

Correct Answer: Ensure the computerized system is validated (CSV) and that control logic and alarms function within PQ acceptance criteria

Q16. Which best describes the relationship between risk assessment and PQ?

  • Risk assessment is only for procurement, not PQ
  • Risk assessment identifies critical equipment functions and helps define the scope and depth of PQ activities
  • Risk assessment replaces PQ completely
  • Risk assessment is only used after PQ failure

Correct Answer: Risk assessment identifies critical equipment functions and helps define the scope and depth of PQ activities

Q17. What is a meaningful metric to demonstrate process capability during PQ?

  • Number of operators trained irrespective of process performance
  • Process capability indices (Cp, Cpk) and control charts showing the process is stable and centered within limits
  • Weight of the machine components
  • Number of pages in the PQ protocol

Correct Answer: Process capability indices (Cp, Cpk) and control charts showing the process is stable and centered within limits

Q18. Which statement about PQ documentation is correct?

  • PQ documentation should be minimal to save time
  • PQ documentation must be complete, traceable, include raw data, deviations with justification, and a formal report with conclusions
  • PQ documentation can be verbal if witnessed by QA
  • PQ documentation is kept only by the vendor

Correct Answer: PQ documentation must be complete, traceable, include raw data, deviations with justification, and a formal report with conclusions

Q19. When qualifying a lyophilizer by PQ, which parameter is critical to monitor throughout a production run?

  • Room wallpaper color
  • Product vial temperature, chamber pressure and shelf temperature profiles related to critical quality attributes
  • Number of visitors in the corridor
  • Supplier delivery times

Correct Answer: Product vial temperature, chamber pressure and shelf temperature profiles related to critical quality attributes

Q20. After successful PQ, what is the typical next step to ensure ongoing performance?

  • Archive PQ documents and never revisit the equipment
  • Implement routine monitoring, periodic requalification based on risk and change control, and trending of critical parameters
  • Replace the equipment immediately
  • Remove all labels and identification from the equipment

Correct Answer: Implement routine monitoring, periodic requalification based on risk and change control, and trending of critical parameters

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