IPQC for tablets, capsules, ointments and suppositories MCQs With Answer

Introduction: This blog presents a focused set of in-process quality control (IPQC) multiple-choice questions specifically for tablets, capsules, ointments, and suppositories, tailored for M.Pharm students. These MCQs cover critical checkpoints during manufacturing, such as granulation end-points, compression parameters, capsule filling checks, ointment rheology, and suppository displacement/melting assessments. Emphasis is placed on practical IPQC tests, sampling strategies, common acceptance criteria, and troubleshooting indicators used on production lines. Use these questions to reinforce theoretical understanding, prepare for viva/boards, and sharpen decision-making skills required for on-line quality assurance during pharmaceutical production.

Q1. Which in-process check is most appropriate for monitoring the consistency of granules before tablet compression?

• Disintegration test of compressed tablets
• Granule particle size distribution and flow properties
• Dissolution profile of API
• Ointment penetration

Correct Answer: Granule particle size distribution and flow properties

Q2. During tablet compression, an immediate loss of tablet weight within a batch indicates which likely problem?

• Tooling misalignment or hopper feed issue
• Excessive coating application
• Low drug potency
• Incorrect dissolution medium

Correct Answer: Tooling misalignment or hopper feed issue

Q3. Which IPQC test is most useful to detect weak mechanical strength of tablets that may cause breakage during packaging?

• Friability test
• Bacterial endotoxin test
• pH of dissolution medium
• Moisture sorption isotherm

Correct Answer: Friability test

Q4. For hard gelatin capsules, which in-process parameter is crucial to monitor to prevent brittleness and cracking?

• Tablet friability
• Capsule shell moisture content
• Coating weight gain
• Dissolution medium temperature

Correct Answer: Capsule shell moisture content

Q5. In-process content uniformity assessment during tablet manufacture is intended to verify:

• That tablets dissolve within 5 minutes
• The uniform distribution of active ingredient among individual units
• The absence of microbial contamination
• The hardness of the tablet coating

Correct Answer: The uniform distribution of active ingredient among individual units

Q6. Which in-process check is specific to ointment manufacturing to ensure batch-to-batch consistency of spreadability?

• Tablet thickness measurement
• Penetration or viscosity measurement
• Capsule disintegration
• Suppository melting point

Correct Answer: Penetration or viscosity measurement

Q7. A sudden increase in tablet weight variation trend during compression is best investigated first by checking:

• Coating oven temperature
• Feed frame and hopper feed rate
• Dissolution apparatus calibration
• Ointment homogenizer speed

Correct Answer: Feed frame and hopper feed rate

Q8. Which dissolution apparatus is commonly used for immediate-release tablets during IPQC dissolution testing?

• Apparatus 3 (reciprocating cylinder)
• Apparatus 1 (basket) or 2 (paddle) depending on tablet type
• Apparatus 6 (rotating paddle over disk)
• Viscometer

Correct Answer: Apparatus 1 (basket) or 2 (paddle) depending on tablet type

Q9. What in-process test would detect incomplete sealing or leaks in soft gelatin capsules?

• Friability test
• Leak test (e.g., dye ingress or vacuum leak detection)
• Penetration test
• Displacement value determination

Correct Answer: Leak test (e.g., dye ingress or vacuum leak detection)

Q10. For suppository production, the ‘displacement value’ is used to:

• Determine hardness of tablets
• Calculate amount of moulding base displaced by active ingredient
• Measure microbial contamination
• Assess viscosity of ointment

Correct Answer: Calculate amount of moulding base displaced by active ingredient

Q11. Which IPQC parameter is most critical to monitor during tablet coating to avoid mottling and poor adhesion?

• Coating pan load, inlet temperature and spray rate
• Displacement value of suppositoy bases
• Capsule shell color uniformity
• Viscosity of ointment base at room temperature

Correct Answer: Coating pan load, inlet temperature and spray rate

Q12. In-process microbial monitoring for non-sterile ointments primarily focuses on:

• Endotoxin levels
• Total viable count and specified objectionable organisms
• Tablet disintegration time
• Dissolution rate

Correct Answer: Total viable count and specified objectionable organisms

Q13. Which control is an effective IPQC measure to prevent capping and lamination in tablets?

• Monitor granule compression properties and pre-compression forces
• Increase coating thickness
• Perform dissolution testing every hour
• Reduce capsule shell moisture

Correct Answer: Monitor granule compression properties and pre-compression forces

Q14. When producing hard capsules, an IPQC check to ensure correct fill weight is typically performed by:

• Measuring tablet hardness
• Periodic sampling and weighing of filled capsules
• Assessing ointment spreadability
• Running a microbial limit test on the shell

Correct Answer: Periodic sampling and weighing of filled capsules

Q15. Which in-process observation in ointment manufacture would indicate inadequate emulsification?

• Phase separation or oiling off
• Uniform tablet coating
• Capsule brittleness
• Low dissolution rate

Correct Answer: Phase separation or oiling off

Q16. For tablets, which IPQC measurement gives direct information about resistance to fracture under tensile or compressive stress?

• Displacement value
• Hardness (crushing strength)
• Microbial count
• Melting point

Correct Answer: Hardness (crushing strength)

Q17. An in-process check for suppositories to ensure content uniformity after moulding would include:

• Measurement of tablet thickness
• Sampling units for active content assay and weight variation
• Bacterial endotoxin testing
• Capsule leakage test

Correct Answer: Sampling units for active content assay and weight variation

Q18. Which in-process parameter should be monitored to avoid tablet sticking to punches?

• Ambient lighting in the production area
• Lubricant level in formulation and punch surface condition
• Suppository displacement value
• Viscosity of coating solution only

Correct Answer: Lubricant level in formulation and punch surface condition

Q19. During scale-up of ointment production, which IPQC is essential to confirm that rheological properties remain consistent?

• Coating pan speed measurement
• Viscosity or rheometry and penetration testing
• Capsule shell thickness only
• Tablet friability only

Correct Answer: Viscosity or rheometry and penetration testing

Q20. What is the primary purpose of in-process visual inspection of tablets and capsules on the production line?

• To determine dissolution profile
• To detect physical defects such as chips, cracks, incorrect imprint or colour variation
• To measure active substance assay accurately
• To perform microbial limit tests

Correct Answer: To detect physical defects such as chips, cracks, incorrect imprint or colour variation

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