Performance qualification (PQ) MCQs With Answer

Performance qualification (PQ) MCQs With Answer

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Introduction

Performance qualification (PQ) MCQs With Answer is a focused quiz collection designed for M.Pharm students studying Pharmaceutical Validation. This set emphasizes the principles, protocols, acceptance criteria, and practical challenges of PQ — the stage that confirms equipment, systems, or processes deliver consistent product quality under routine operating conditions. The questions cover PQ planning, worst‑case selection, sampling/statistics, environmental monitoring, autoclave and HVAC PQ specifics, cleaning and process transfer, documentation, and appropriate responses to PQ failures. Each MCQ tests conceptual understanding and applied decision‑making to prepare students for real‑world validation tasks and regulatory expectations in pharmaceutical manufacturing environments.

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

  • To establish design requirements for equipment and facilities
  • To demonstrate that equipment or a system consistently performs according to operational and process specifications under routine production conditions
  • To verify installation of equipment according to manufacturer’s drawings
  • To develop the cleaning procedure for equipment

Correct Answer: To demonstrate that equipment or a system consistently performs according to operational and process specifications under routine production conditions

Q2. How does PQ differ from Operational Qualification (OQ)?

  • OQ verifies routine production performance; PQ checks installation
  • PQ is only documentary review, while OQ is practical testing
  • OQ confirms equipment operates according to design limits; PQ confirms performance under actual, routine production conditions
  • PQ is performed before IQ, whereas OQ is performed after production

Correct Answer: OQ confirms equipment operates according to design limits; PQ confirms performance under actual, routine production conditions

Q3. When should Performance Qualification typically be performed in a validation lifecycle?

  • Prior to installation of equipment
  • After Installation Qualification (IQ) and Operational Qualification (OQ), before routine commercial production
  • Only during FDA inspections
  • Only when equipment fails

Correct Answer: After Installation Qualification (IQ) and Operational Qualification (OQ), before routine commercial production

Q4. Which document most directly defines acceptance criteria used during PQ?

  • Manufacturer’s marketing brochure
  • Approved PQ protocol and user requirements/specifications derived from product and process needs
  • Maintenance logbook
  • Raw material purchase orders

Correct Answer: Approved PQ protocol and user requirements/specifications derived from product and process needs

Q5. For a batch manufacturing process, a commonly recommended number of consecutive successful runs during PQ is:

  • One run
  • Three consecutive successful runs representative of routine production
  • Ten runs always
  • Only runs until one failure occurs

Correct Answer: Three consecutive successful runs representative of routine production

Q6. Selecting worst‑case conditions for PQ should be based on:

  • Random selection without documentation
  • Risk assessment considering critical process parameters and product attributes
  • Only the most convenient conditions for operators
  • Manufacturer’s preferred settings irrespective of product characteristics

Correct Answer: Risk assessment considering critical process parameters and product attributes

Q7. What role does a media fill (aseptic process simulation) play in PQ for sterile manufacturing?

  • It evaluates the efficacy of chemical cleaning agents
  • It simulates the sterile production process using growth media to demonstrate the aseptic process maintains sterility under routine conditions
  • It is used only for HVAC qualification
  • It replaces the need for environmental monitoring

Correct Answer: It simulates the sterile production process using growth media to demonstrate the aseptic process maintains sterility under routine conditions

Q8. What key elements must be included in PQ documentation and final report?

  • Only raw data with no interpretation
  • Protocol approval, test records, raw data, deviations, investigations, statistical analysis, conclusions and sign‑offs
  • Only a one‑page summary
  • Supplier invoices

Correct Answer: Protocol approval, test records, raw data, deviations, investigations, statistical analysis, conclusions and sign‑offs

Q9. How often should equipment or system requalification (PQ revalidation) be performed?

  • Never, once PQ is done it is permanent
  • On a periodic schedule defined by quality system (e.g., annually) and after significant changes or failures
  • Only when a new operator is hired
  • Every week regardless of use

Correct Answer: On a periodic schedule defined by quality system (e.g., annually) and after significant changes or failures

Q10. During PQ of a production area, environmental monitoring is performed to:

  • Replace cleaning validation studies
  • Provide evidence that routine environmental conditions (particle counts, microbiological levels, pressure differentials) are within defined limits during production
  • Only train personnel
  • Document financial costs of cleanroom operations

Correct Answer: Provide evidence that routine environmental conditions (particle counts, microbiological levels, pressure differentials) are within defined limits during production

Q11. Which parameters are typically validated during PQ of a HVAC system supporting production?

  • Color of the duct painting only
  • Airflow pattern and velocity, pressure differentials, temperature, humidity, particle and microbial counts under operational loads
  • Only electrical wiring continuity
  • Vendor sales performance

Correct Answer: Airflow pattern and velocity, pressure differentials, temperature, humidity, particle and microbial counts under operational loads

Q12. In computerised system validation (CSV), what is the focus of PQ for the computerized system?

  • Installing hardware without testing
  • Testing the system in its intended operational environment with end users, real or simulated transactions and routine operating conditions
  • Only reviewing supplier documentation
  • Performing IQ activities only

Correct Answer: Testing the system in its intended operational environment with end users, real or simulated transactions and routine operating conditions

Q13. For autoclave sterilizer PQ, which test is typically included to demonstrate sterilization under routine loading?

  • Visual inspection of door paint
  • Biological indicator runs within a representative worst‑case load, chemical indicators and temperature/pressure profiles
  • Inventory count of sterilizer parts
  • Only a review of operator competency records

Correct Answer: Biological indicator runs within a representative worst‑case load, chemical indicators and temperature/pressure profiles

Q14. Acceptance criteria for PQ should be established based on:

  • Personal opinion of the operator
  • Product requirements, regulatory guidance, process risk assessment and historical data where applicable
  • Lowest acceptable limits from unrelated industries
  • Advertising claims

Correct Answer: Product requirements, regulatory guidance, process risk assessment and historical data where applicable

Q15. Which statistical considerations are important when designing a PQ sampling and testing plan?

  • No statistics are needed; eyeballing results is sufficient
  • Sample size justification, confidence levels, acceptance criteria, and variability estimates to ensure conclusions are scientifically supported
  • Only the mean value without dispersion
  • Using statistics from unrelated processes without justification

Correct Answer: Sample size justification, confidence levels, acceptance criteria, and variability estimates to ensure conclusions are scientifically supported

Q16. Which approach is most appropriate for selecting sampling locations and frequency during PQ?

  • Choose the locations closest to the door only
  • Use risk‑based selection targeting worst‑case and critical points with scientifically justified frequency
  • Sample everything every minute
  • Let production personnel decide ad hoc during the run

Correct Answer: Use risk‑based selection targeting worst‑case and critical points with scientifically justified frequency

Q17. How is PQ related to process validation (PV)?

  • PQ is unrelated and optional for PV
  • PQ is a component of process validation that demonstrates equipment and systems perform consistently under routine conditions as part of overall PV lifecycle
  • PQ replaces all other validation stages
  • PV is performed only after product recall

Correct Answer: PQ is a component of process validation that demonstrates equipment and systems perform consistently under routine conditions as part of overall PV lifecycle

Q18. When transferring a validated process to a new manufacturing site, PQ at the receiving site should:

  • Be skipped if the sending site had PQ
  • Be performed to demonstrate the process and equipment perform under the receiving site’s routine conditions and personnel
  • Only include IQ documentation transfer
  • Be replaced by marketing approval

Correct Answer: Be performed to demonstrate the process and equipment perform under the receiving site’s routine conditions and personnel

Q19. In cleaning validation, what does PQ verify?

  • Only detergent shelf life
  • That the cleaning procedure consistently yields residue and microbial levels below defined acceptance limits during routine operation
  • Only that the cleaning SOP exists
  • That operators like the cleaning equipment

Correct Answer: That the cleaning procedure consistently yields residue and microbial levels below defined acceptance limits during routine operation

Q20. If a critical PQ test fails during qualification runs, the immediate appropriate action is to:

  • Ignore the result and approve PQ anyway
  • Stop the qualification, quarantine affected product, investigate root cause, implement CAPA, and repeat PQ as required
  • Release product immediately to meet schedule
  • Call marketing to change product specifications

Correct Answer: Stop the qualification, quarantine affected product, investigate root cause, implement CAPA, and repeat PQ as required

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