Qualification of dissolution apparatus MCQs With Answer

Qualification of dissolution apparatus MCQs With Answer

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Introduction:
Qualification of dissolution apparatus is a critical component of pharmaceutical validation for M.Pharm students preparing for industry and regulatory roles. This set of MCQs focuses on the practical and regulatory aspects of apparatus qualification including IQ/OQ/PQ principles, calibration, hydrodynamics, critical tolerances (temperature, speed, paddle/basket positioning), sampling and filtration, sink conditions, and requalification triggers. Questions progress from fundamental concepts to operational troubleshooting and method-specific performance checks, emphasizing real-world scenarios and commonly tested USP requirements. These MCQs will help reinforce understanding of how to ensure dissolution systems deliver reliable, reproducible results required for product release and regulatory compliance.

Q1. Which sequence correctly represents the three primary phases of equipment qualification for a dissolution apparatus?

  • Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ)
  • Design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ)
  • Documentation, Calibration, Maintenance
  • Qualification, Validation, Verification

Correct Answer: Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ)

Q2. Which activity is typically performed during the Installation Qualification (IQ) of a dissolution system?

  • Verification of equipment components, documentation of manuals, and utility connections
  • Routine dissolution testing of production batches
  • Long-term trend analysis of dissolution profiles
  • Performing method robustness studies

Correct Answer: Verification of equipment components, documentation of manuals, and utility connections

Q3. What is the primary objective of Operational Qualification (OQ) for dissolution apparatus?

  • Demonstrating equipment operates within specified ranges (rpm, temperature, alignment, and flow rates)
  • Establishing clinical performance of the drug product
  • Designing the dissolution vessel geometry
  • Conducting long-term stability studies

Correct Answer: Demonstrating equipment operates within specified ranges (rpm, temperature, alignment, and flow rates)

Q4. Performance Qualification (PQ) of a dissolution apparatus typically involves which of the following?

  • Demonstrating consistent product dissolution under routine conditions using representative batches
  • Installing the apparatus and verifying serial number
  • Verifying electrical supply and grounding only
  • Drafting the equipment procurement specification

Correct Answer: Demonstrating consistent product dissolution under routine conditions using representative batches

Q5. What is the accepted temperature control specification for dissolution medium (physiological testing) per common pharmacopeial requirements?

  • 37.0°C ±0.5°C
  • 25.0°C ±1.0°C
  • 40.0°C ±2.0°C
  • 37.0°C ±2.0°C

Correct Answer: 37.0°C ±0.5°C

Q6. What is the usual acceptable accuracy tolerance for rotational speed (rpm) of dissolution paddles or baskets?

  • Within ±2% of set speed
  • Within ±10% of set speed
  • Within ±0.01% of set speed
  • Within ±5% of set speed

Correct Answer: Within ±2% of set speed

Q7. For USP Apparatus 2 (paddle), what is the recommended distance from the paddle center to the bottom of the vessel?

  • 25 mm ±2 mm
  • 10 mm ±1 mm
  • 50 mm ±5 mm
  • 5 mm ±1 mm

Correct Answer: 25 mm ±2 mm

Q8. What is the standard specification for the basket mesh in USP Apparatus 1?

  • 40-mesh stainless steel basket (approx. 400 µm openings)
  • 10-mesh plastic basket
  • 100-mesh gold-plated basket
  • 0.45 µm filter basket

Correct Answer: 40-mesh stainless steel basket (approx. 400 µm openings)

Q9. Which factors most strongly influence hydrodynamics and mixing patterns in a dissolution vessel?

  • Agitator position, vessel geometry, and probe placement
  • Color of the vessel, operator height, and room lighting
  • Packaging material of the tablet only
  • Room humidity exclusively

Correct Answer: Agitator position, vessel geometry, and probe placement

Q10. Which instrument is commonly used to verify the rotational speed of paddle or basket shafts during OQ?

  • Stroboscope or calibrated non-contact tachometer
  • Mercury thermometer
  • pH meter
  • Analytical balance

Correct Answer: Stroboscope or calibrated non-contact tachometer

Q11. What defines an appropriate sink condition for dissolution testing?

  • Sink condition where the maximum dissolved drug concentration is less than one-third of drug solubility (i.e., >3× solubility)
  • Any medium with pH 7.0
  • Medium volume less than 500 mL
  • No solids visible after 5 minutes

Correct Answer: Sink condition where the maximum dissolved drug concentration is less than one-third of drug solubility (i.e., >3× solubility)

Q12. Which filter pore size is commonly recommended for routine sampling during dissolution testing to remove particulates?

  • 0.45 µm membrane filter
  • 5.0 µm coarse filter
  • 10.0 µm gauze filter
  • 2.0 µm ceramic filter

Correct Answer: 0.45 µm membrane filter

Q13. When withdrawing a sample from a dissolution vessel, what is the correct practice regarding volume replacement?

  • Replace withdrawn volume with fresh pre-warmed medium and account for dilution in calculations
  • Do not replace any volume and ignore dilution effects
  • Replace with cold medium to stop dissolution
  • Replace with deionized water at room temperature without correction

Correct Answer: Replace withdrawn volume with fresh pre-warmed medium and account for dilution in calculations

Q14. For a six-vessel dissolution test during qualification, what is a commonly accepted repeatability limit expressed as relative standard deviation (RSD)?

  • Relative standard deviation (RSD) not greater than 2% for six vessels
  • RSD can be up to 25% for routine checks
  • RSD must be exactly 0%
  • RSD not greater than 50% for six vessels

Correct Answer: Relative standard deviation (RSD) not greater than 2% for six vessels

Q15. What is the primary purpose of torque testing or monitoring during dissolution apparatus qualification?

  • To detect excessive friction or obstruction during rotation indicating misalignment or fouled shafts
  • To measure pH changes in the medium
  • To calibrate UV spectrophotometers
  • To weigh the vessel accurately

Correct Answer: To detect excessive friction or obstruction during rotation indicating misalignment or fouled shafts

Q16. When is it appropriate to use sinkers in dissolution testing?

  • When tablets or capsules float and need to be kept submerged to ensure proper dissolution
  • Only when testing transdermal patches
  • When pH of medium is greater than 8.0
  • When the apparatus is an autoclave

Correct Answer: When tablets or capsules float and need to be kept submerged to ensure proper dissolution

Q17. Which aspects should be validated for fiber-optic in situ UV probes used in dissolution testing?

  • Linearity, specificity, fouling behavior, and probe pathlength validation
  • Only the color of the probe
  • Probe brand warranty period
  • Operator manual language

Correct Answer: Linearity, specificity, fouling behavior, and probe pathlength validation

Q18. How can air bubbles adhered to the dosage form affect dissolution results?

  • They reduce effective surface area and can artificially slow dissolution rates
  • They accelerate dissolution by increasing agitation
  • They have no measurable effect
  • They only affect colorimetric assays

Correct Answer: They reduce effective surface area and can artificially slow dissolution rates

Q19. In the qualification lifecycle, where does Design Qualification (DQ) typically fit?

  • Design Qualification (DQ) precedes IQ to ensure design meets user and regulatory requirements
  • DQ is performed after PQ
  • DQ is not part of qualification
  • DQ is only required for software, not equipment

Correct Answer: Design Qualification (DQ) precedes IQ to ensure design meets user and regulatory requirements

Q20. When should a dissolution apparatus be requalified?

  • After relocation, major repairs, changes affecting performance, and at scheduled periodic intervals (e.g., annually)
  • Only once at initial installation and never again
  • Every week regardless of use
  • Only when an investigator requests an audit

Correct Answer: After relocation, major repairs, changes affecting performance, and at scheduled periodic intervals (e.g., annually)

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