In-process quality control (IPQC) procedures MCQs With Answer

This set of in-process quality control (IPQC) multiple-choice questions is designed for M.Pharm students preparing for advanced QC & QA exams and professional practice. The questions focus on critical IPQC procedures used during pharmaceutical manufacturing — sampling strategies, process checks (e.g., weight, hardness, disintegration, moisture), process analytical technology (PAT), environmental and aseptic controls, calibration and documentation, and regulatory expectations. Each item targets conceptual understanding and practical decision-making needed to detect, control, and document deviations in real time. Use these MCQs to test knowledge, reinforce best practices, and prepare for viva voce or written assessments in pharmaceutical quality assurance.

Q1. Which IPQC parameter is most appropriate to monitor immediately after granulation to ensure downstream compression performance?

• Microbial limit test
• Bulk density and granule size distribution
• Assay of active pharmaceutical ingredient (API)
• Finished product dissolution

Correct Answer: Bulk density and granule size distribution

Q2. During tablet compression, which in-process check is commonly performed to control tablet weight variation?

• pH of granulation slurry
• In-process weight checks by sampling from the tablet press
• Dissolution testing of a single tablet
• Cross contamination swab test

Correct Answer: In-process weight checks by sampling from the tablet press

Q3. Process Analytical Technology (PAT) tools in IPQC are primarily used to:

• Replace final product release testing completely
• Provide real-time monitoring and control of critical process parameters
• Reduce the need for trained personnel on the shop floor
• Eliminate the requirement for calibration of equipment

Correct Answer: Provide real-time monitoring and control of critical process parameters

Q4. Which of the following is a critical in-process control for coating operations?

• Particle size of API
• Coating pan load, spray rate, inlet temperature and weight gain
• Microbial endotoxin level
• pH of the final product solution

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

Q5. When should in-process sampling plans be qualified and justified?

• Only after a batch failure occurs
• During process validation and included in the control strategy
• When the regulatory inspector specifically requests it
• After product commercialization only

Correct Answer: During process validation and included in the control strategy

Q6. For sterile aseptic manufacturing, which IPQC measure directly monitors environmental quality during production?

• Endotoxin assay on finished product
• Continuous viable and non-viable particle monitoring in critical zones
• Stability testing at three months
• Disintegration test of tablets

Correct Answer: Continuous viable and non-viable particle monitoring in critical zones

Q7. Which in-process control is most suitable to check content uniformity during capsule filling?

• Hardness testing of capsules
• Sampling individual capsules for assay of API
• pH testing of dissolution media
• Visual inspection of capsule color only

Correct Answer: Sampling individual capsules for assay of API

Q8. What is the primary purpose of establishing in-process hold points in a manufacturing procedure?

• To allow indefinite storage of intermediate material without control
• To permit quality checks and prevent progression of nonconforming batches
• To reduce the need for operator training
• To bypass regulatory inspections

Correct Answer: To permit quality checks and prevent progression of nonconforming batches

Q9. Which statistical tool is commonly used in IPQC to detect process drift or trends over time?

• Pareto chart only
• Control charts (e.g., Shewhart X̄-R charts)
• Simple linear regression without limits
• Stability indicating HPLC

Correct Answer: Control charts (e.g., Shewhart X̄-R charts)

Q10. During wet granulation, which IPQC test helps ensure correct moisture content before drying?

• Residual solvent analysis by GC
• Loss on drying (moisture content) and end-point determination by near-infrared (NIR)
• pH of the granulation slurry after drying
• Tablet friability

Correct Answer: Loss on drying (moisture content) and end-point determination by near-infrared (NIR)

Q11. Calibration of in-process measuring instruments is required because:

• It increases the life of the instrument only
• It ensures measurements are traceable, accurate and within specified limits
• It is only a regulatory paperwork exercise
• It eliminates the need for SOPs

Correct Answer: It ensures measurements are traceable, accurate and within specified limits

Q12. In-process visual inspection of tablets during coating could identify which types of defects?

• API potency deviations only
• Color variation, picking, bridging and seam defects
• Residual solvent levels
• Microbial contamination inside the tablet core

Correct Answer: Color variation, picking, bridging and seam defects

Q13. Which IPQC check would best detect segregation problems in a powder blend intended for capsules?

• Disintegration test of filled capsules
• Content uniformity testing on samples taken from different blender locations
• pH measurement of the blend
• Sterility testing

Correct Answer: Content uniformity testing on samples taken from different blender locations

Q14. If an in-process test fails during compression, the immediate correct GMP action is to:

• Continue the run and investigate after batch completion
• Stop the process, quarantine affected material, investigate root cause and document
• Adjust acceptance criteria to pass the test
• Ignore the result if visually tablets look fine

Correct Answer: Stop the process, quarantine affected material, investigate root cause and document

Q15. Which in-process parameter is critical to monitor for liquid oral syrups to ensure homogeneity and dosing accuracy?

• Tablet hardness
• Viscosity and fill weight checks
• Coating thickness
• Granule porosity

Correct Answer: Viscosity and fill weight checks

Q16. For in-process residual solvent monitoring, which analytical method is most commonly used?

• Fourier-transform infrared (FTIR)
• Gas chromatography (GC) with appropriate detection
• Microbial enumeration
• UV-visible spectrophotometry

Correct Answer: Gas chromatography (GC) with appropriate detection

Q17. Which documentation is essential to accompany IPQC checks during a production run?

• Uncontrolled handwritten notes kept by operators only
• Completed batch production record (BPR) with time-stamped IPQC entries and deviations
• Final product label draft
• Only electronic photographs without signatures

Correct Answer: Completed batch production record (BPR) with time-stamped IPQC entries and deviations

Q18. In aseptic processing, an in-process alert limit exceeding viable particle counts should trigger which immediate action?

• Ignore if the batch appears sterile later
• Investigate, assess potential product impact, consider process stop and sampling for contamination
• Increase batch production speed to finish sooner
• Reduce frequency of environmental monitoring

Correct Answer: Investigate, assess potential product impact, consider process stop and sampling for contamination

Q19. Which IPQC approach helps minimize operator-dependent variability during sampling and measurements?

• Removing SOPs and allowing operator judgment
• Use of validated sampling plans, automated sampling devices and calibrated instruments
• Sampling only at the end of shelf-life studies
• Relying solely on visual checks

Correct Answer: Use of validated sampling plans, automated sampling devices and calibrated instruments

Q20. When an in-process trend shows slow drift but still within specification, best QA practice is to:

• Ignore the trend since results are within specification
• Investigate the root cause, document trend analysis and apply corrective/preventive action if needed
• Relax process controls to accept wider drift
• Stop trend monitoring until a failure occurs

Correct Answer: Investigate the root cause, document trend analysis and apply corrective/preventive action if needed

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