Qualification of tablet compression machines MCQs With Answer

Introduction

This quiz set focuses on the qualification of tablet compression machines, a critical component of pharmaceutical validation for M.Pharm students. It covers Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), including machine design, calibration of load cells, tooling, process parameters (compression force, turret speed, dwell time), in‑process controls, acceptance criteria, preventive maintenance, and documentation requirements under GMP. Questions emphasize practical aspects: how to set and verify limits, sample plans, risk assessment, troubleshooting common faults (capping, sticking, weight variation), and when requalification is required. These MCQs will help consolidate theoretical knowledge and apply it to real-world validation activities.

Q1. Which document is primarily used to record the detailed configuration, utilities, and installation checks of a new tablet compression machine during validation?

• Operational Qualification Protocol
• Performance Qualification Protocol
• Installation Qualification Protocol
• Cleaning Validation Report

Correct Answer: Installation Qualification Protocol

Q2. During OQ of a tablet press the acceptance test for compression force calibration should verify which of the following?

• Consistency of tablet color across batches
• Accuracy and linearity of force readings across the specified force range
• Operator training completion certificates
• Stability of the active pharmaceutical ingredient

Correct Answer: Accuracy and linearity of force readings across the specified force range

Q3. Which parameter is most directly responsible for tablet hardness and density and is therefore critical in OQ/PQ testing?

• Turret speed
• Compression (tablet) force
• Pan coating time
• Granule particle size distribution

Correct Answer: Compression (tablet) force

Q4. What is the primary purpose of Performance Qualification (PQ) for a tablet compression machine?

• To confirm the machine is installed correctly
• To ensure the machine performs consistently under normal production conditions
• To document the machine’s purchase details
• To validate the cleaning procedure only

Correct Answer: To ensure the machine performs consistently under normal production conditions

Q5. Which of the following is an appropriate sampling plan consideration for PQ of tablet weight variation?

• Test one tablet per batch
• Use a statistically justified sample size and random sampling across the run
• Only sample tablets at the beginning of the run
• Sample only visually acceptable tablets

Correct Answer: Use a statistically justified sample size and random sampling across the run

Q6. Risk assessment (e.g., FMEA) before qualification mainly helps to:

• Reduce the number of qualification tests to one
• Identify critical machine components and process parameters to focus on during IQ/OQ/PQ
• Replace the need for preventive maintenance
• Determine the color of tablets

Correct Answer: Identify critical machine components and process parameters to focus on during IQ/OQ/PQ

Q7. Which calibration activity is essential for ensuring accurate compression force readings on a tablet press?

• Calibration of turret rotational speed sensor only
• Calibration of load cell or force transducer used for compression force measurement
• Calibration of the ambient humidity sensor only
• Calibration of tablet coating thickness gauge

Correct Answer: Calibration of load cell or force transducer used for compression force measurement

Q8. In PQ runs, monitoring dwell time is important because:

• It determines how long tablets are stored
• It affects compression dynamics and can influence capping, lamination and hardness
• It sets the cleaning frequency for the machine
• It measures operator response time

Correct Answer: It affects compression dynamics and can influence capping, lamination and hardness

Q9. Which acceptance criterion is commonly used for tablet weight variation during PQ?

• All tablets must be identical to the nearest microgram
• Within pharmacopeial limits (e.g., ±5% or ±7.5%) depending on tablet weight and specification
• No tablet should deviate by more than 50%
• Only average weight needs to match target

Correct Answer: Within pharmacopeial limits (e.g., ±5% or ±7.5%) depending on tablet weight and specification

Q10. During machine qualification, which checks are typically included in IQ regarding utilities?

• Verification of power supply, compressed air, cooling water and their compliance with machine requirements
• Only checking the color of utility pipes
• Reviews of supplier invoices for utility installation
• Training of operators on utilities

Correct Answer: Verification of power supply, compressed air, cooling water and their compliance with machine requirements

Q11. Which of the following indicates the need for requalification of a tablet compression machine?

• Minor cosmetic repainting of the machine exterior
• Major modification of force measurement system or replacement of critical control electronics
• Routine change in tablet formula within validated ranges without other changes
• Daily cleaning as per SOP

Correct Answer: Major modification of force measurement system or replacement of critical control electronics

Q12. What role do tooling (punches and dies) inspections play in machine qualification?

• Tooling inspections are irrelevant for validation
• They ensure correct geometry, no wear or damage, and traceability which affect tablet quality and reproducibility
• They only determine the tablet identifier engraving
• They are only checked during maintenance shutdowns and not during qualification

Correct Answer: They ensure correct geometry, no wear or damage, and traceability which affect tablet quality and reproducibility

Q13. Which in-process measurement is most useful for detecting die fill issues during PQ?

• Tablet colorimeter reading
• Tablet weight measurement across the run
• Coating hardness test
• Microbial bioburden count

Correct Answer: Tablet weight measurement across the run

Q14. Which environmental condition should be controlled or monitored during compression machine qualification and routine operation?

• Ambient music level
• Room temperature and relative humidity
• Cloud cover outside the facility
• Operator shift patterns

Correct Answer: Room temperature and relative humidity

Q15. Which document describes step-by-step procedures to operate and qualify the tablet press and should be available before validation?

• Master Batch Record
• Standard Operating Procedure (SOP) for operation and qualification
• Employee resume
• Packing list from supplier

Correct Answer: Standard Operating Procedure (SOP) for operation and qualification

Q16. How is turret speed variation controlled and verified during OQ/PQ?

• By subjective operator feeling only
• Using calibrated tachometers or encoder feedback and verifying setpoints versus measured speed across the operating range
• By measuring tablet color changes
• By adjusting feed frame height exclusively

Correct Answer: Using calibrated tachometers or encoder feedback and verifying setpoints versus measured speed across the operating range

Q17. Which of the following is a critical acceptance test for ejection settings during PQ?

• Confirming ejection force is within acceptable limits to avoid tablet damage and punch breakage
• Ensuring ejection produces a loud sound
• Measuring the tablet’s dissolution immediately after ejection
• Verifying only the ejection pin color

Correct Answer: Confirming ejection force is within acceptable limits to avoid tablet damage and punch breakage

Q18. In validation reports, traceability of changeable parts (like punches) is important because:

• It allows linking specific tooling to specific batches and product quality outcomes
• It increases the aesthetic value of documentation
• It reduces the need for routine cleaning
• It is required only for regulatory inspections and not for quality

Correct Answer: It allows linking specific tooling to specific batches and product quality outcomes

Q19. Which statistical approach is commonly applied to analyze PQ data for process capability of tablet weight or hardness?

• Use of process capability indices such as Cp and Cpk
• Counting the number of operators
• Measuring the machine’s paint thickness
• Non-statistical visual inspection only

Correct Answer: Use of process capability indices such as Cp and Cpk

Q20. Which practice ensures long-term validated status of a tablet compression machine after initial qualification?

• Ignoring scheduled maintenance to avoid downtime
• Implementing a documented preventive maintenance and calibration schedule, periodic review and requalification when indicated
• Allowing untrained personnel to perform repairs without records
• Changing acceptance criteria arbitrarily to avoid failures

Correct Answer: Implementing a documented preventive maintenance and calibration schedule, periodic review and requalification when indicated

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com