Process Validation – Tablet Coating MCQs With Answer

Process Validation – Tablet Coating MCQs With Answer

This quiz collection is designed for M.Pharm students studying Scale Up & Technology Transfer and focuses on process validation specific to tablet coating. The questions cover the scientific and regulatory principles of coating validation, critical process parameters (CPPs), critical quality attributes (CQAs), equipment qualification, scale-up challenges, in-process monitoring, PAT tools, and common defects with their root causes. Emphasis is placed on designing robust validation protocols, establishing acceptance criteria, and applying risk-based approaches during IQ/OQ/PQ. These MCQs will help students consolidate theoretical knowledge and prepare for practical decision-making during technology transfer and commercial-scale coating operations.

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

• To qualify operators performing the coating process
• To ensure the coating process consistently produces tablets meeting predefined quality attributes
• To verify the cleaning procedures for coating equipment
• To maximize production output regardless of quality

Correct Answer: To ensure the coating process consistently produces tablets meeting predefined quality attributes

Q2. Which of the following is a critical quality attribute (CQA) directly influenced by the tablet coating process?

• Assay of active pharmaceutical ingredient in bulk powder
• Coating thickness and weight gain
• Raw material supplier qualification
• Compression tablet hardness before coating

Correct Answer: Coating thickness and weight gain

Q3. During coating scale-up, which parameter change is most likely to alter coating uniformity when moving from lab to commercial pan?

• Colour of the polymer used
• Increase in batch size and pan fill leading to altered bed dynamics
• Changing the tablet shape slightly
• Switching from aqueous to organic solvent without adjusting spray rate

Correct Answer: Increase in batch size and pan fill leading to altered bed dynamics

Q4. Which in-process analytical tool is commonly used for non-destructive monitoring of film thickness during coating?

• High-performance liquid chromatography (HPLC)
• Near-infrared spectroscopy (NIR)
• Atomic absorption spectroscopy (AAS)
• Gas chromatography (GC)

Correct Answer: Near-infrared spectroscopy (NIR)

Q5. In a coating process, which of the following is considered a critical process parameter (CPP)?

• Operator’s preferred shift timing
• Spray atomization air pressure
• Batch record font size
• Supplier invoicing schedule

Correct Answer: Spray atomization air pressure

Q6. During performance qualification (PQ) of a coating operation, what is the typical acceptance criterion timeframe for demonstrating consistency?

• Single batch confirmation only
• Three consecutive commercial-scale batches under normal operating ranges
• Ten laboratory mini-batches
• One pilot batch and one commercial run

Correct Answer: Three consecutive commercial-scale batches under normal operating ranges

Q7. Which coating defect is most commonly caused by over-wetting due to excessive spray rate or low inlet air temperature?

• Pitting
• Mottling
• Twinning
• Orange peel

Correct Answer: Pitting

Q8. Which polymer property is most important when selecting a film former for an enteric coating?

• Solubility at gastric pH and insolubility at intestinal pH
• High melting point
• Low viscosity in organic solvents only
• Ability to form colored films

Correct Answer: Solubility at gastric pH and insolubility at intestinal pH

Q9. Which plasticizer effect is desired in film coating formulations?

• Increase brittleness of the film
• Improve flexibility and reduce film cracking
• Decrease adhesion of coating to tablet
• Increase particulate contamination

Correct Answer: Improve flexibility and reduce film cracking

Q10. For validation of solvent-based coating, which specific test is critical to ensure regulatory compliance?

• Residual solvent analysis
• Tablet disintegration in water at 25°C
• Color stability under UV only
• Coating pan surface roughness

Correct Answer: Residual solvent analysis

Q11. Which statistical metric is commonly used during coating process validation to assess long-term process capability?

• t-test
• Cp and Cpk
• Chi-square
• Mean absolute deviation only

Correct Answer: Cp and Cpk

Q12. What is the recommended approach when establishing worst-case conditions for coating validation?

• Choose the easiest-to-coat formulation only
• Evaluate factors that increase risk to CQAs and select boundary settings that stress the process
• Use arbitrary extremes outside equipment capability
• Ignore environmental variables like humidity

Correct Answer: Evaluate factors that increase risk to CQAs and select boundary settings that stress the process

Q13. Which parameter directly affects droplet size during atomization in spray coating?

• Tablet core color
• Nozzle orifice diameter and atomization air pressure
• Film coating plasticizer chemical name

Correct Answer: Nozzle orifice diameter and atomization air pressure

Q14. In coating validation, why are placebo runs or dummy batches often performed?

• To train operators only
• To establish equipment settings and assess film behavior without risking product
• To validate analytical methods unrelated to coating
• To reduce cleaning frequency

Correct Answer: To establish equipment settings and assess film behavior without risking product

Q15. Which environmental condition is most critical to control during aqueous film coating?

• Ambient light intensity
• Relative humidity and inlet/outlet air temperature
• Magnetic field strength
• CO2 concentration

Correct Answer: Relative humidity and inlet/outlet air temperature

Q16. What is the main purpose of a subcoat or seal coat in tablet coating?

• To increase dissolution rate of API
• To prevent interaction between core and topcoat, improving adhesion and hiding core color
• To reduce tablet hardness
• To add flavor to tablets

Correct Answer: To prevent interaction between core and topcoat, improving adhesion and hiding core color

Q17. Which sampling plan is generally acceptable during PQ to verify coating uniformity across a batch?

• One tablet from the first and last 100 tablets only
• Representative samples taken systematically from beginning, middle and end of batch, often per sampling plan in protocol
• Only visual inspection of a random handful of tablets
• Sampling only from the middle of the batch

Correct Answer: Representative samples taken systematically from beginning, middle and end of batch, often per sampling plan in protocol

Q18. Which coating defect is typically caused by poor adhesion between coating layers or between coating and core?

• Bridging
• Peeling or lifting
• Mottling due to pigment distribution
• Sugar bloom

Correct Answer: Peeling or lifting

Q19. In technology transfer for coating, what documentation is essential to transfer from development to manufacturing?

• Only the batch size and product name
• Complete coating formulation, process parameters, equipment configuration, validation protocols, and acceptance criteria
• Only the coating color codes
• Marketing brochures and packaging designs

Correct Answer: Complete coating formulation, process parameters, equipment configuration, validation protocols, and acceptance criteria

Q20. Which PAT approach can provide real-time measurement of coating weight gain during film coating?

• Offline HPLC assay after coating
• Near infrared (NIR) spectroscopy correlated to weight gain models
• Visual inspection by operator
• Gravimetric loss of pan motor

Correct Answer: Near infrared (NIR) spectroscopy correlated to weight gain models

Download