Qualification of Tablet Compression Machine MCQs With Answer

Introduction: This blog provides focused multiple-choice questions on the Qualification of Tablet Compression Machines tailored for M.Pharm students studying MIP 202T – Scale Up & Technology Transfer. The questions cover installation, operational and performance qualification (IQ, OQ, PQ), critical process parameters (CPPs), critical quality attributes (CQAs), measurement and calibration methods, tooling, control systems, documentation and requalification triggers. Each MCQ is designed to deepen understanding of machine qualification principles, practical testing procedures, acceptance criteria and regulatory expectations. Use these practice questions to assess readiness for exams and to reinforce practical knowledge required during scale-up, technology transfer and validation activities involving tablet presses.

Q1. Which activity is primarily performed during Installation Qualification (IQ) for a tablet compression machine?

• Verifying process robustness with multiple batches
• Documenting and confirming that the equipment is installed according to manufacturer specifications and utilities are correctly connected
• Measuring product dissolution for finished tablets
• Conducting accelerated stability studies

Correct Answer: Documenting and confirming that the equipment is installed according to manufacturer specifications and utilities are correctly connected

Q2. Operational Qualification (OQ) of a tablet press typically focuses on:

• Long-term stability of the tablet formulation
• Operational performance of machine systems across defined operating ranges such as turret speed, feed frame settings and compression force
• Raw material supplier audits
• Marketing strategy for the tablet product

Correct Answer: Operational performance of machine systems across defined operating ranges such as turret speed, feed frame settings and compression force

Q3. Performance Qualification (PQ) for a tablet compression machine is best described as:

• Verification that the machine is built according to design drawings
• Demonstration that the machine can consistently produce product meeting quality attributes under actual production conditions
• Testing raw material impurities
• Cleaning validation of the analytical laboratory

Correct Answer: Demonstration that the machine can consistently produce product meeting quality attributes under actual production conditions

Q4. Which of the following is considered a critical process parameter (CPP) for tablet compression?

• Packaging carton color
• Tablet compression force (main compression)
• Invoice number format
• Marketing batch code

Correct Answer: Tablet compression force (main compression)

Q5. A requalification of a tablet press should be performed when:

• The press is used daily without interruption
• There is a major change that affects process performance, such as replacing tooling geometry or control software
• The operator changes the uniform of the production staff
• Labels of finished cartons are reprinted for marketing reasons

Correct Answer: There is a major change that affects process performance, such as replacing tooling geometry or control software

Q6. Which instrument is commonly used to directly measure the compression force generated by the tablet press?

• Moisture analyzer
• Load cell or force transducer installed on the compression platform
• pH meter
• Spectrophotometer

Correct Answer: Load cell or force transducer installed on the compression platform

Q7. Pre-compression in a tablet press is used to:

• Cool down the machine components
• Reduce air entrapment and improve powder bed uniformity before main compression
• Increase tablet coating adhesion
• Label the tablets with batch number

Correct Answer: Reduce air entrapment and improve powder bed uniformity before main compression

Q8. During OQ, which test verifies consistent fill depth and weight control across turret stations?

• Vacuum decay test
• Tablet weight variation and in-process monitoring across multiple stations at different turret speeds
• Microbial limit test
• Barrier integrity test

Correct Answer: Tablet weight variation and in-process monitoring across multiple stations at different turret speeds

Q9. Tooling qualification should include verification of:

• Punch and die dimensions, alignment, finish and traceability to tooling ID records
• Sales invoices for the tooling supplier
• Marketing brochures for different punch styles
• Color of the punch handles

Correct Answer: Punch and die dimensions, alignment, finish and traceability to tooling ID records

Q10. Which environmental conditions are most important to record during PQ runs of a tablet press?

• Ambient noise level and room lighting color
• Temperature and relative humidity in the compression room
• Number of visitors in the production area
• Cafeteria menu for the day

Correct Answer: Temperature and relative humidity in the compression room

Q11. Factory Acceptance Testing (FAT) differs from Site Acceptance Testing (SAT) in that:

• FAT is performed at the vendor site to verify equipment functionality before shipment; SAT is performed at the installation site to confirm performance after installation
• FAT is only for marketing purposes; SAT is technical
• FAT assesses final product quality; SAT checks supplier invoices
• FAT is for software only; SAT is for hardware only

Correct Answer: FAT is performed at the vendor site to verify equipment functionality before shipment; SAT is performed at the installation site to confirm performance after installation

Q12. In OQ, what is the purpose of running the press at upper and lower operational limits?

• To waste materials to test cleanliness
• To evaluate process robustness and identify safe operating ranges and limits for critical parameters
• To produce pilot batches for stability only
• To calibrate marketing claims about production speed

Correct Answer: To evaluate process robustness and identify safe operating ranges and limits for critical parameters

Q13. Which documentation is essential to include in a Machine Qualification Protocol?

• Acceptance criteria, test methods, responsibilities, list of required utilities and calibration status of measuring instruments
• Only the machine photo and supplier address
• Employee personal opinions on machine design
• Promotional material for the machine manufacturer

Correct Answer: Acceptance criteria, test methods, responsibilities, list of required utilities and calibration status of measuring instruments

Q14. A common PQ acceptance approach for tablet production is to:

• Run three consecutive commercial-size batches that meet predefined CQAs and documented acceptance criteria
• Run one small lab-scale batch and accept results automatically
• Rely solely on historical data from other sites
• Use a single tablet to represent whole batch performance

Correct Answer: Run three consecutive commercial-size batches that meet predefined CQAs and documented acceptance criteria

Q15. Which of the following is NOT typically a CQA evaluated during tablet press qualification?

• Tablet hardness
• Disintegration time
• Tablet color uniformity
• Supplier corporate logo design

Correct Answer: Supplier corporate logo design

Q16. When validating computerized control systems on tablet presses, attention should be given to:

• Data integrity, user authentication, audit trails and backup procedures
• Only the color scheme of the HMI screens
• Whether the machine has a coffee maker nearby
• Marketing benefits of touchscreen controls

Correct Answer: Data integrity, user authentication, audit trails and backup procedures

Q17. Which preventive maintenance (PM) item is critical to maintain consistent compression performance?

• Regular inspection and lubrication of cams, turret bearings, and punches, and verification of punch/die condition
• Changing the production staff daily
• Annual repainting of the press exterior
• Decorating the control panel with stickers

Correct Answer: Regular inspection and lubrication of cams, turret bearings, and punches, and verification of punch/die condition

Q18. During OQ, measurement of which parameter helps correlate compression force to tablet hardness?

• Air pressure in the building
• Compression force and dwell time profiling with downstream hardness testing
• Number of operators on shift
• Electricity bill amounts

Correct Answer: Compression force and dwell time profiling with downstream hardness testing

Q19. Which change to the tablet press would most likely require a requalification (full/partial)?

• Changing the brand of paper used for office printers
• Replacing standard concave punches with new ejection geometry and different turret pitch
• Updating the canteen menu
• Repainting the facility corridor

Correct Answer: Replacing standard concave punches with new ejection geometry and different turret pitch

Q20. Traceability during qualification requires recording which of the following?

• Tooling IDs, calibration certificates of instruments used, software version, batch numbers and operator identities during qualification tests
• Favorite music of operators
• Daily weather forecast only
• Sales projections for the next quarter

Correct Answer: Tooling IDs, calibration certificates of instruments used, software version, batch numbers and operator identities during qualification tests

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