Qualification of tap density tester MCQs With Answer

Qualification of tap density tester MCQs With Answer

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Introduction

This question bank focuses on the qualification of tap density testers — a vital instrument in powder characterization and tablet development — tailored for M. Pharma students. It covers the full validation lifecycle: design/installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), plus calibration, maintenance, risk assessment and documentation requirements. Questions emphasize practical aspects such as measurement principles (bulk vs tapped density), calculation of related indices (Hausner ratio, Carr’s index), critical operational parameters, acceptance criteria, and requalification triggers. Use these MCQs to strengthen conceptual understanding and prepare for practical validation tasks and viva examinations in pharmaceutical manufacturing and quality assurance.

Q1. What is the primary objective of Installation Qualification (IQ) for a tap density tester?

  • To verify that the instrument meets performance criteria under production conditions
  • To demonstrate that the device is installed according to manufacturer specifications and facility requirements
  • To validate the analytical method used for density measurement
  • To establish long term calibration intervals

Correct Answer: To demonstrate that the device is installed according to manufacturer specifications and facility requirements

Q2. During Operational Qualification (OQ) of a tap density tester, which parameter is typically verified?

  • Stability of production batches over several months
  • Proper instrument installation and utility connections
  • Functionality of tap stroke height, tap rate and counting accuracy within specified limits
  • Regulatory approval of the instrument model

Correct Answer: Functionality of tap stroke height, tap rate and counting accuracy within specified limits

Q3. What is the main focus of Performance Qualification (PQ) for a tap density tester?

  • Confirming delivery of the device to the site
  • Ensuring that the instrument performs consistently with actual product samples under routine conditions
  • Verifying vendor credentials
  • Performing destructive testing on instrument components

Correct Answer: Ensuring that the instrument performs consistently with actual product samples under routine conditions

Q4. Which calculation correctly defines the Hausner ratio?

  • Bulk density divided by true density
  • Tapped density divided by bulk density
  • [(Tapped − Bulk)/Tapped] × 100
  • True density divided by tapped density

Correct Answer: Tapped density divided by bulk density

Q5. How is Carr’s (compressibility) index most commonly calculated?

  • [(Tapped density − Bulk density) / Tapped density] × 100
  • Bulk density × Tapped density
  • Tapped density / Bulk density
  • [(Bulk density − Tapped density) / Bulk density] × 100

Correct Answer: [(Tapped density − Bulk density) / Tapped density] × 100

Q6. Which of the following is an essential instrument check in OQ to ensure reproducible tapping motion?

  • Verification of electrical wiring color codes
  • Measurement of stroke height and verification of tap rate stability
  • Checking the outer paint finish for scratches
  • Replacing the sample funnel with a larger diameter funnel

Correct Answer: Measurement of stroke height and verification of tap rate stability

Q7. Which environmental factor must be controlled during PQ runs of a tap density tester because it can alter powder behavior?

  • Ambient lighting intensity
  • Room humidity and electrostatic charge
  • Noise level in the laboratory
  • Color of the bench surface

Correct Answer: Room humidity and electrostatic charge

Q8. In a qualification protocol, what is the purpose of acceptance criteria?

  • To document the vendor contact details
  • To set measurable limits that determine whether a test step passes or fails
  • To list all raw materials used in an experiment
  • To define the laboratory dress code

Correct Answer: To set measurable limits that determine whether a test step passes or fails

Q9. Which documentation element is normally produced after completing IQ/OQ/PQ of the tap density tester?

  • Change control request without data
  • Qualification report summarizing results, deviations, and approvals
  • Only vendor brochures
  • Unapproved raw printouts

Correct Answer: Qualification report summarizing results, deviations, and approvals

Q10. Which action would typically trigger requalification of a tap density tester?

  • Routine cleaning as per SOP
  • Significant repair or replacement of mechanical components affecting tapping motion
  • Normal battery replacement in a handheld calculator
  • Minor software cosmetic update with no functional change

Correct Answer: Significant repair or replacement of mechanical components affecting tapping motion

Q11. For method transfer or PQ, why is using representative product batches important?

  • Representative batches increase ambient noise
  • They ensure the instrument performance is verified under real material and process variability
  • They speed up the IQ process
  • They replace the need for documented SOPs

Correct Answer: They ensure the instrument performance is verified under real material and process variability

Q12. What is a common nonconformance to record when tapped density results show large variability between replicates?

  • Possible issues with sample filling technique, trapped air, electrostatic charges or instrument tap inconsistencies
  • Incorrect company logo on printouts
  • Operator’s handwriting style
  • Ambient light flicker

Correct Answer: Possible issues with sample filling technique, trapped air, electrostatic charges or instrument tap inconsistencies

Q13. Which calibration activity is most relevant to ensure accurate count of taps?

  • Validation of the laboratory’s internet speed
  • Verification of the tap counter against a calibrated electronic counter or traceable time-base
  • Measurement of sample color homogeneity
  • Testing of laboratory glassware for visual clarity

Correct Answer: Verification of the tap counter against a calibrated electronic counter or traceable time-base

Q14. When preparing an OQ script for a tap density tester, which element is essential?

  • List of cafeteria menu items
  • Detailed test steps with acceptance criteria, test equipment, and measurement methods
  • Purchase orders for consumables only
  • Colors used in the instrument label

Correct Answer: Detailed test steps with acceptance criteria, test equipment, and measurement methods

Q15. Which of the following best describes a critical quality attribute (CQA) related to tap density testing?

  • The brand of the instrument manufacturer
  • The measured tapped density value that impacts downstream unit operations (e.g., tablet weight uniformity, flow)
  • The physical size of the laboratory
  • The color of the powder

Correct Answer: The measured tapped density value that impacts downstream unit operations (e.g., tablet weight uniformity, flow)

Q16. Which of these is an appropriate risk-based justification for frequency of requalification?

  • Frequency based on arbitrary calendar date unrelated to use
  • Frequency determined by risk assessment considering usage rate, criticality, historical performance and change history
  • Never requalify once passed initially
  • Always requalify daily regardless of risk

Correct Answer: Frequency determined by risk assessment considering usage rate, criticality, historical performance and change history

Q17. Which preventive maintenance activity helps maintain consistent tap density results?

  • Regular lubrication and inspection of mechanical linkages and verification of tap mechanism alignment
  • Changing the laboratory carpet
  • Repainting the instrument every month
  • Rotating the instrument 180° daily

Correct Answer: Regular lubrication and inspection of mechanical linkages and verification of tap mechanism alignment

Q18. What is the best way to demonstrate traceability of calibration data for the tap density tester?

  • Keep verbal agreements with the vendor
  • Maintain calibration certificates referencing national or international standards and unique identifiers for calibration artifacts
  • Rely solely on in-house verbal checks
  • Use uncalibrated local weights without documentation

Correct Answer: Maintain calibration certificates referencing national or international standards and unique identifiers for calibration artifacts

Q19. Why is a change control system important for instrument qualification status?

  • It tracks cosmetic changes to the building
  • It ensures any modification that may affect performance is evaluated and, if needed, triggers requalification
  • It replaces the need for training
  • It delays necessary maintenance indefinitely

Correct Answer: It ensures any modification that may affect performance is evaluated and, if needed, triggers requalification

Q20. In writing a PQ protocol for a tap density tester, which acceptance demonstration is most appropriate?

  • Showing that the device powers on without testing with samples
  • Performing replicate measurements on representative materials and demonstrating results meet predefined precision and accuracy criteria
  • Collecting vendor sales brochures
  • Allowing any untrained person to operate and record any numbers

Correct Answer: Performing replicate measurements on representative materials and demonstrating results meet predefined precision and accuracy criteria

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