Qualification of friability tester MCQs With Answer

Qualification of friability tester MCQs With Answer

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Introduction: Qualification of friability tester MCQs With Answer is designed to help M.Pharm students master the principles and regulatory requirements for qualifying friability testers used in tablet quality control. This concise quiz set covers instrument components, operational parameters (speed, time, sample size), sample preparation, calibration and performance checks, and the role of IQ/OQ/PQ in validation. Emphasis is placed on acceptance criteria, troubleshooting common failures, environmental influences, and data integrity during qualification. These MCQs are crafted to deepen conceptual understanding and prepare students for practical laboratory qualification tasks and relevant exam questions in pharmaceutical validation.

Q1. What is the fundamental principle behind a tablet friability tester?

  • Measurement of tablet dissolution rate under simulated gastric conditions
  • Assessment of weight loss due to mechanical abrasion and shock during tumbling
  • Determination of tensile strength by diametral compression
  • Evaluation of tablet porosity via mercury intrusion

Correct Answer: Assessment of weight loss due to mechanical abrasion and shock during tumbling

Q2. Which component of the friability tester directly causes abrasion to the tablets?

  • Weighing balance
  • Drum or rotating cylinder with internal baffles
  • Disintegration medium
  • Compression punch

Correct Answer: Drum or rotating cylinder with internal baffles

Q3. According to pharmacopeial procedure, what is the commonly used rotation speed and number of revolutions for a standard friability test?

  • 50 rpm for 200 revolutions
  • 25 rpm for 100 revolutions
  • 10 rpm for 50 revolutions
  • 100 rpm for 10 revolutions

Correct Answer: 25 rpm for 100 revolutions

Q4. What is the typical acceptance criterion for percent weight loss in friability testing of uncoated tablets?

  • Less than or equal to 1% weight loss
  • Less than or equal to 5% weight loss
  • Greater than 2% weight loss
  • Exactly 0% weight loss

Correct Answer: Less than or equal to 1% weight loss

Q5. Which document is primarily used to record installation details like serial number, location, and utilities for a friability tester?

  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Installation Qualification (IQ)
  • Change Control

Correct Answer: Installation Qualification (IQ)

Q6. During OQ of a friability tester, which parameter is typically verified?

  • Tablet formulation composition
  • Manufacturer’s marketing claims
  • Instrument RPM accuracy, timer function, and drum speed stability
  • Patient compliance rates

Correct Answer: Instrument RPM accuracy, timer function, and drum speed stability

Q7. For PQ of a friability tester, which activity best demonstrates ongoing instrument performance under routine conditions?

  • Verifying serial number against purchase order
  • Running reference standard tablets and assessing percent weight loss reproducibility
  • Checking the color of the instrument paint
  • Reviewing supplier brochures

Correct Answer: Running reference standard tablets and assessing percent weight loss reproducibility

Q8. What is the correct sequence of qualification activities for a friability tester?

  • PQ → OQ → IQ
  • IQ → OQ → PQ
  • OQ → PQ → IQ
  • IQ → PQ → OQ

Correct Answer: IQ → OQ → PQ

Q9. Which calibration check is essential for a friability tester during qualification?

  • pH meter calibration
  • Calibration of rotational speed (RPM) and timer accuracy
  • Calibration of HPLC detector wavelength
  • Calibration of autoclave pressure gauge

Correct Answer: Calibration of rotational speed (RPM) and timer accuracy

Q10. When performing a friability test, why are tablets typically dedusted before weighing?

  • To change the tablet hardness
  • To ensure the initial weight excludes loose fines and gives accurate percent weight loss
  • To enhance tablet disintegration
  • To sterilize the tablet surface

Correct Answer: To ensure the initial weight excludes loose fines and gives accurate percent weight loss

Q11. During qualification, a friability tester returns variable percent weight loss for identical reference tablets. What is the most likely cause?

  • Improper tablet formulation
  • Instability of drum speed, loose mounting, or worn abrasion surfaces
  • Incorrect pharmacopeial acceptance criterion
  • Change in ambient lighting

Correct Answer: Instability of drum speed, loose mounting, or worn abrasion surfaces

Q12. What is an appropriate sample size for a typical friability test?

  • 1 tablet only
  • 10 tablets or a representative sample as per monograph
  • 500 tablets
  • Only half a tablet per test

Correct Answer: 10 tablets or a representative sample as per monograph

Q13. Which of the following is NOT a typical acceptance criterion for operational qualification of a friability tester?

  • RPM within specified tolerance (e.g., ±1% of setpoint)
  • Timer accuracy within specified tolerance
  • Percent friability for sample tablets matching compendial limit during OQ runs
  • Color of the operator’s lab coat

Correct Answer: Color of the operator’s lab coat

Q14. How is percent friability calculated after a friability test?

  • (Final weight / Initial weight) × 100
  • [(Initial weight − Final weight) / Initial weight] × 100
  • Initial weight − Final weight (no percent)
  • Final weight − Initial weight (no percent)

Correct Answer: [(Initial weight − Final weight) / Initial weight] × 100

Q15. Which environmental condition should be controlled during friability qualification experiments?

  • Ambient noise level
  • Room humidity and temperature
  • Magnetic field strength
  • UV light intensity

Correct Answer: Room humidity and temperature

Q16. In qualification documentation, what does traceability of results typically refer to?

  • Ability to trace operator’s home address
  • Linking test data to specific instrument, sample IDs, operator, and conditions
  • Tracing tablet dissolution profiles only
  • Tracing supplier invoices

Correct Answer: Linking test data to specific instrument, sample IDs, operator, and conditions

Q17. Which corrective action is appropriate if a friability tester’s RPM deviates beyond specified tolerance during OQ?

  • Ignore the deviation and proceed
  • Adjust/repair the motor, recalibrate RPM, and re-run OQ tests
  • Change tablet formulation to compensate
  • Switch off humidity control

Correct Answer: Adjust/repair the motor, recalibrate RPM, and re-run OQ tests

Q18. Why might coated tablets have different acceptance criteria for friability compared to uncoated tablets?

  • Coatings change aesthetic appearance but not mechanical properties
  • Coatings alter surface hardness and resistance to abrasion, often requiring stricter or tailored limits
  • Coated tablets are heavier so percent loss is irrelevant
  • Regulators do not consider coated tablets

Correct Answer: Coatings alter surface hardness and resistance to abrasion, often requiring stricter or tailored limits

Q19. Which of the following is a recommended routine preventive maintenance activity for a friability tester affecting qualification status?

  • Regular cleaning of the drum and replacement of worn abrasion surfaces
  • Replacing the lab’s fluorescent bulbs
  • Repainting the instrument once a year
  • Changing the building’s HVAC filters monthly only

Correct Answer: Regular cleaning of the drum and replacement of worn abrasion surfaces

Q20. When writing an SOP for friability tester qualification, which element is essential?

  • Operator’s favorite music playlist
  • Stepwise procedures for IQ, OQ, PQ, acceptance criteria, data recording, and corrective actions
  • Only the instrument’s purchase order number
  • Marketing claims about tablet benefits

Correct Answer: Stepwise procedures for IQ, OQ, PQ, acceptance criteria, data recording, and corrective actions

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