Process Validation – Compression MCQs With Answer

Introduction:

This quiz set on Process Validation – Compression is designed specifically for M.Pharm students studying Scale Up & Technology Transfer (MIP 202T). It focuses on the critical aspects of validating tablet compression processes, including equipment qualification, critical process parameters (CPPs), critical quality attributes (CQAs), in-process controls, PAT tools and statistical acceptance criteria. The questions are aimed to deepen conceptual understanding and practical application during scale-up, technology transfer and routine production. Use these MCQs to test your readiness for examinations and real-world validation tasks, and to identify areas needing further study in compression process control and troubleshooting.

Q1. What is the primary objective of process validation for tablet compression?

• To document equipment specifications only
• To ensure the compression process consistently produces tablets meeting predetermined quality attributes
• To speed up production and reduce cycle time
• To reduce raw material costs

Correct Answer: To ensure the compression process consistently produces tablets meeting predetermined quality attributes

Q2. Which sequence describes the FDA-recommended stages of process validation?

• IQ → OQ → PQ
• Process design → Process qualification → Continued process verification
• Raw material testing → In-process control → Finished product release
• Formulation development → Scale-up → Commercial production

Correct Answer: Process design → Process qualification → Continued process verification

Q3. For initial process qualification of a solid oral immediate-release tablet, how many consecutive successful full-scale batches are conventionally required?

• One
• Two
• Three
• Five

Correct Answer: Three

Q4. Which of the following lists best represents critical quality attributes (CQAs) for compressed tablets?

• Tablet color, supplier name, packaging type
• Tablet weight, hardness, dissolution, content uniformity
• Raw material density, ambient humidity, operator ID
• Compression machine brand, punch material, warehouse location

Correct Answer: Tablet weight, hardness, dissolution, content uniformity

Q5. Which set contains typical critical process parameters (CPPs) for a rotary tablet compression machine?

• Compression force, turret speed, feed frame speed, fill depth
• API melting point, tablet color, label font
• Warehouse temperature, invoice date, batch code
• Packaging line speed, carton size, pallet height

Correct Answer: Compression force, turret speed, feed frame speed, fill depth

Q6. Increasing dwell time during compression typically has which effect on tablets?

• Decreases tablet hardness due to increased elastic recovery
• Increases tablet hardness and tensile strength due to enhanced particle bonding
• Has no effect on tablet properties
• Only affects tablet color

Correct Answer: Increases tablet hardness and tensile strength due to enhanced particle bonding

Q7. Which mechanism is most commonly responsible for tablet capping or lamination during compression?

• Excessive tablet colorant
• Air entrapment and elastic recovery (insufficient plastic deformation and bonding)
• Over-dosage of binder to the point of becoming a paste
• Use of rounded punch corners

Correct Answer: Air entrapment and elastic recovery (insufficient plastic deformation and bonding)

Q8. How does punch and die tooling influence tablet compression outcomes?

• Tooling only affects production speed, not tablet quality
• Punch geometry and tooling condition influence tablet weight distribution, appearance and compaction behavior
• Tooling only influences tablet dissolution
• Tooling selection is irrelevant if compression force is high

Correct Answer: Punch geometry and tooling condition influence tablet weight distribution, appearance and compaction behavior

Q9. Which in-process control is most critical during a compression run to detect process drift early?

• Hourly measurement of tablet weight and thickness and visual inspection of tablet face
• End-of-run sterility test
• Monthly calibration of the labeling machine
• Final batch potency test only

Correct Answer: Hourly measurement of tablet weight and thickness and visual inspection of tablet face

Q10. What useful information does a force-displacement (compression) profile provide during validation?

• The shelf life of the tablet
• Insight into compaction behavior, bonding event, and detection of abnormal events like sticking or capping
• API assay value
• Certificate of analysis for excipients

Correct Answer: Insight into compaction behavior, bonding event, and detection of abnormal events like sticking or capping

Q11. In process validation, what is a commonly accepted minimum value for process capability index Cpk to demonstrate a state of control?

• Cpk < 0.5
• Cpk = 1.0
• Cpk ≥ 1.33
• Cpk ≥ 2.5

Correct Answer: Cpk ≥ 1.33

Q12. Which PAT tool is most commonly applied for real-time monitoring of blend uniformity prior to compression?

• High-performance liquid chromatography (offline only)
• Near-infrared (NIR) spectroscopy
• Thermogravimetric analysis
• Atomic absorption spectroscopy

Correct Answer: Near-infrared (NIR) spectroscopy

Q13. If an out-of-specification (OOS) result is obtained during validation compression runs, what is the immediate appropriate action?

• Ignore it and continue production
• Stop the run, quarantine affected material and perform a documented investigation into root cause and impact
• Change specifications to accept the result
• Ship the batch and note the deviation later

Correct Answer: Stop the run, quarantine affected material and perform a documented investigation into root cause and impact

Q14. Which change would typically trigger revalidation of the compression process?

• Minor administrative change in documentation wording
• Significant changes in formulation, compression equipment or critical process parameters
• Changing the color of the production floor paint
• Updating the supplier contact phone number

Correct Answer: Significant changes in formulation, compression equipment or critical process parameters

Q15. What is the principal focus of Performance Qualification (PQ) in equipment qualification for a tablet press?

• Installing the equipment in the room
• Verifying that equipment operates according to vendor manuals only
• Demonstrating that the equipment performs reliably using actual product under simulated or real production conditions
• Obtaining supplier warranty documents

Correct Answer: Demonstrating that the equipment performs reliably using actual product under simulated or real production conditions

Q16. Excess magnesium stearate in a formulation most likely causes which compression-related problem?

• Increased tablet hardness and faster dissolution
• Decreased tablet hardness and slower dissolution due to hydrophobic lubricant layer
• Improved compaction and zero friability
• Change in tablet color to bright red

Correct Answer: Decreased tablet hardness and slower dissolution due to hydrophobic lubricant layer

Q17. How does powder segregation during feeding affect final tablet quality?

• It can lead to content uniformity failures and variability in tablet potency
• It only affects tablet color
• Segregation improves tablet compressibility
• Segregation is irrelevant if tablets are film-coated

Correct Answer: It can lead to content uniformity failures and variability in tablet potency

Q18. During scale-up from pilot to commercial press, increasing turret speed without other adjustments primarily reduces which parameter?

• Fill depth
• Dwell time, potentially reducing tablet hardness if not compensated
• API potency
• Granule particle size

Correct Answer: Dwell time, potentially reducing tablet hardness if not compensated

Q19. A representative sampling plan for validating a compression run should include samples taken from which locations of the batch?

• Only the first 10 tablets
• Samples from the beginning, middle and end of the run (and from different turret positions if applicable)
• Only from the packaging line
• Only from the last 100 tablets

Correct Answer: Samples from the beginning, middle and end of the run (and from different turret positions if applicable)

Q20. What is the main advantage of Continued Process Verification (CPV) compared with traditional episodic revalidation?

• CPV eliminates the need for any in-process checks
• CPV provides ongoing real-time assurance of process performance and product quality using statistical monitoring and PAT, enabling earlier detection of trends
• CPV requires no documentation
• CPV allows unchecked changes to process parameters

Correct Answer: CPV provides ongoing real-time assurance of process performance and product quality using statistical monitoring and PAT, enabling earlier detection of trends

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