Qualification of hardness tester MCQs With Answer

Introduction: Qualification of hardness tester MCQs With Answer is an essential resource for M.Pharm students preparing for exams and practical validations. This blog focuses on the principles and regulatory expectations when qualifying tablet hardness testers used in pharmaceutical development and production. It covers installation, operational and performance qualification (IQ/OQ/PQ), calibration, traceability, environmental influences, software considerations and documentation. Questions emphasize understanding of acceptance criteria, measurement uncertainty, repeatability, linearity and risk-based requalification. The MCQs are designed to reinforce applied knowledge, prepare for real-world validation protocols and ensure compliance with GMP and regulatory guidance. Use these practice questions to assess and deepen your competency in instrument qualification.

Q1. What is the primary purpose of qualifying a tablet hardness tester during pharmaceutical validation?

• To ensure the instrument provides reliable and reproducible hardness measurements within specified limits
• To verify sterility of the instrument prior to use
• To confirm dissolution rate of tablets
• To establish assay potency of the drug

Correct Answer: To ensure the instrument provides reliable and reproducible hardness measurements within specified limits

Q2. Which sequential stages make up a standard qualification protocol for a hardness tester?

• Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
• Functional Test only
• Qualification followed by validation only
• Calibration only

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

Q3. Which activity is typically performed during the Installation Qualification (IQ) of a hardness tester?

• Verifying instrument documentation, utility connections, environmental requirements and delivery of accessories
• Assessing long-term performance under production loads
• Comparing product dissolution profiles
• Performing routine tablet testing during commercial production

Correct Answer: Verifying instrument documentation, utility connections, environmental requirements and delivery of accessories

Q4. Operational Qualification (OQ) for a hardness tester commonly includes testing for which parameters?

• Accuracy, precision (repeatability), linearity and response time
• Cleaning validation and bioburden limits
• Stability of the pharmaceutical product
• Packaging integrity

Correct Answer: Accuracy, precision (repeatability), linearity and response time

Q5. What is the main objective of Performance Qualification (PQ) for a hardness tester?

• To demonstrate consistent performance under routine production conditions with typical tablet types
• To install the instrument in the laboratory
• To perform initial calibration only
• To qualify supplier audits

Correct Answer: To demonstrate consistent performance under routine production conditions with typical tablet types

Q6. Which unit is preferred by modern compendia for reporting tablet hardness?

• Newton (N)
• Pascal (Pa)
• Kilograms per meter squared (kg/m2)
• Milligram (mg)

Correct Answer: Newton (N)

Q7. Which USP chapter provides guidance specifically for Analytical Instrument Qualification applicable to devices like hardness testers?

• USP 1058 Analytical Instrument Qualification
• USP 1226
• USP 791
• USP 1116

Correct Answer: USP 1058 Analytical Instrument Qualification

Q8. Which of the following parameters is critical to verify in the OQ to ensure force application reliability?

• Load application accuracy, platen alignment, dwell time and sensor response
• Color of the instrument casing
• Manufacturer’s marketing claims
• Tablet coating thickness only

Correct Answer: Load application accuracy, platen alignment, dwell time and sensor response

Q9. How should the calibration frequency of a hardness tester be determined?

• Based on a risk-assessment considering manufacturer recommendations, usage, criticality and historical data
• Strictly every day regardless of use
• Only when the instrument breaks down
• Only once at installation and never again

Correct Answer: Based on a risk-assessment considering manufacturer recommendations, usage, criticality and historical data

Q10. Calibration weights and force standards used for qualifying a hardness tester should be traceable to which reference?

• National metrology institute standards (e.g., NIST or equivalent)
• The instrument manufacturer’s internal standards only
• Local supplier certificates without traceability
• Previous production batch records

Correct Answer: National metrology institute standards (e.g., NIST or equivalent)

Q11. What does “measurement uncertainty” describe in the context of hardness tester qualification?

• A quantitative estimate of the doubt associated with a measurement result including systematic and random components
• The range of acceptable tablet hardness for a product
• The manufacturing tolerance on tablet weight
• The difference between two operators’ techniques only

Correct Answer: A quantitative estimate of the doubt associated with a measurement result including systematic and random components

Q12. Which consideration is essential when validating embedded software or data capture systems of a modern hardness tester?

• Verification of installation, functionality, access controls, audit trails and data integrity per electronic records requirements
• Only the physical installation of the instrument matters
• Software validation is unnecessary for hardness measurements
• Only the printer output needs to be checked

Correct Answer: Verification of installation, functionality, access controls, audit trails and data integrity per electronic records requirements

Q13. How is repeatability defined for hardness tester performance qualification?

• Multiple measurements of the same tablet type by the same operator under the same conditions within a short time period
• Different operators measuring different tablet types across several days
• Measuring tablets before and after coating processes only
• Comparing hardness to dissolution results

Correct Answer: Multiple measurements of the same tablet type by the same operator under the same conditions within a short time period

Q14. What is the appropriate approach to verify the linearity of a hardness tester?

• Apply a series of known forces across the measurement range using calibrated force standards and compare measured versus expected values
• Measure tablets of only one hardness value
• Check the instrument’s exterior for wear
• Compare results with visual inspection only

Correct Answer: Apply a series of known forces across the measurement range using calibrated force standards and compare measured versus expected values

Q15. In the context of instrument qualification, what is “drift”?

• A gradual change in instrument response over time that may require recalibration
• An immediate catastrophic failure of the instrument
• A fixed offset that never changes
• The physical movement of the instrument across the lab floor

Correct Answer: A gradual change in instrument response over time that may require recalibration

Q16. Which environmental factors are most likely to influence tablet hardness measurements?

• Temperature and relative humidity in the testing area
• Ambient light intensity only
• Color of the laboratory walls
• Noise levels from adjacent machinery only

Correct Answer: Temperature and relative humidity in the testing area

Q17. Which method is commonly used during qualification to verify platter or platen parallelism of a hardness tester?

• Using gauge blocks, shims or a dial gauge to measure uniform contact across the platen surface
• Weighing the instrument on a balance
• Measuring tablet thickness only
• Running dissolution tests

Correct Answer: Using gauge blocks, shims or a dial gauge to measure uniform contact across the platen surface

Q18. Which risk assessment tool is commonly applied to identify critical failure modes for a qualification plan?

• Failure Mode and Effects Analysis (FMEA)
• SWOT analysis
• Balanced scorecard
• Fishbone diagram only

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q19. Under which circumstances should a hardness tester be requalified?

• After relocation, major repair, software update or when the risk assessment/schedule indicates the need
• Only when a new operator is hired
• Never, once initial qualification is complete
• Only at the end of the product lifecycle

Correct Answer: After relocation, major repair, software update or when the risk assessment/schedule indicates the need

Q20. Which items must be included in the hardness tester validation report?

• IQ/OQ/PQ protocols and results, acceptance criteria, raw data, deviations, corrective actions and traceability of calibration
• Only a statement that the instrument passed
• Only the manufacturer’s brochure
• Only photographs of the instrument

Correct Answer: IQ/OQ/PQ protocols and results, acceptance criteria, raw data, deviations, corrective actions and traceability of calibration

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