In-process quality control (IPQC) in manufacturing MCQs With Answer

Introduction: In-process quality control (IPQC) is a critical component of pharmaceutical manufacturing that ensures product quality is maintained throughout production rather than only at final release. For M.Pharm students, mastering IPQC means understanding which parameters to monitor at each manufacturing stage—raw material checks, granulation, compression, coating, and packaging—and how to interpret results against specifications. This quiz set targets deeper understanding of IPQC principles, sampling strategies, critical process parameters (CPPs), critical quality attributes (CQAs), statistical process control, regulatory expectations under GMP, and practical tests like weight variation, hardness, friability, disintegration, dissolution and microbial monitoring. These questions will reinforce both theory and application for real-world manufacturing environments.

Q1. Which of the following best defines the primary purpose of In-Process Quality Control (IPQC) in pharmaceutical manufacturing?

• To replace final product testing with a single process check
• To monitor and control specific parameters during manufacturing to ensure product quality
• To perform full chemical analysis of raw materials only
• To validate the manufacturing site layout

Correct Answer: To monitor and control specific parameters during manufacturing to ensure product quality

Q2. Which of the following is considered a Critical Quality Attribute (CQA) that IPQC aims to ensure for solid oral dosage forms?

• Color of the manufacturing floor tiles
• Tablet disintegration time
• Employee shift timing
• Supplier lead time

Correct Answer: Tablet disintegration time

Q3. During wet granulation, which in-process test is most indicative of granule readiness for drying and compression?

• Assay of active ingredient in the final tablet
• Moisture content and granule size distribution
• Microbial limit test of compressed tablets
• Coating thickness of finished tablets

Correct Answer: Moisture content and granule size distribution

Q4. For tablets, which IPQC test directly measures mechanical strength and is often used to predict breakage during handling?

• Disintegration test
• Hardness (tablet crushing strength)
• Friability
• Weight variation

Correct Answer: Hardness (tablet crushing strength)

Q5. Which parameter is most relevant to monitor during capsule filling as part of IPQC?

• Coating uniformity
• Fill weight or weight variation of filled capsules
• Blister pack integrity
• Environmental noise levels

Correct Answer: Fill weight or weight variation of filled capsules

Q6. Which statistical tool is commonly used in IPQC to detect shifts or trends in a manufacturing parameter over time?

• ANOVA for final stability studies only
• Control charts (e.g., X-bar and R charts)
• Kaplan-Meier survival analysis
• Fisher’s exact test

Correct Answer: Control charts (e.g., X-bar and R charts)

Q7. In-process sampling plans should be designed primarily based on which principle?

• Random convenience sampling of operators
• Statistical rationale considering variability and risk
• Sampling only when a customer complaint arises
• Daily sampling of a single unit regardless of batch size

Correct Answer: Statistical rationale considering variability and risk

Q8. Which regulatory guideline explicitly emphasizes in-process controls as part of GMP?

• ICH Q14
• EU GMP Annex 1
• WHO Good Manufacturing Practices and many national GMP regulations
• ISO 9001:2015 clause on environmental management

Correct Answer: WHO Good Manufacturing Practices and many national GMP regulations

Q9. A sudden drift in tablet hardness during a compression run is most likely caused by which of the following?

• Change in building ventilation color
• Variation in granule moisture content or compression force
• Expired communal coffee machine
• Operator social media usage during shift

Correct Answer: Variation in granule moisture content or compression force

Q10. What is the primary reason to perform in-process microbial monitoring during the manufacture of sterile products?

• To confirm the batch potency
• To ensure aseptic conditions and prevent sterile product contamination
• To verify tablet hardness
• To measure the pH of non-sterile excipients

Correct Answer: To ensure aseptic conditions and prevent sterile product contamination

Q11. Process Analytical Technology (PAT) applied as part of IPQC is intended to achieve which outcome?

• Replace process controls with final testing only
• Enable real-time monitoring and control of critical process parameters
• Reduce documentation requirements for GMP
• Increase batch cycle time intentionally

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

Q12. Which in-process test is commonly used to assess tablet resistance to abrasion during packaging and transport?

• Disintegration test
• Friability test
• Assay by HPLC
• pH of dissolution medium

Correct Answer: Friability test

Q13. Content uniformity during manufacturing is primarily assessed to prevent which quality problem?

• Incorrect tablet color
• Batch-to-batch variation in manufacturing lead time
• Significant dosage variability between individual units
• Degradation of packaging materials

Correct Answer: Significant dosage variability between individual units

Q14. When should a line clearance be performed as part of IPQC?

• Only at the end of the month
• Before starting a different product or batch on the same line
• When the supervisor remembers
• Only for sterile products

Correct Answer: Before starting a different product or batch on the same line

Q15. Which of the following is considered a Critical Process Parameter (CPP) for tablet compression?

• Ambient background music
• Compression force and dwell time
• Color of the compression machine
• Operator shoe size

Correct Answer: Compression force and dwell time

Q16. Real-time release testing (RTRT) in IPQC is achievable when:

• Final release testing is completely eliminated without justification
• PAT tools and validated models correlate process data to product quality reliably
• Operator experience is the only acceptance criterion
• Regulators permit no in-process monitoring

Correct Answer: PAT tools and validated models correlate process data to product quality reliably

Q17. Which IPQC action is appropriate when a single in-process measurement marginally fails specification but upstream CPPs are within control?

• Automatically reject the batch without investigation
• Perform immediate investigation, remeasure, and assess potential impact on CQAs
• Ignore the result and continue production
• Shut down the entire facility indefinitely

Correct Answer: Perform immediate investigation, remeasure, and assess potential impact on CQAs

Q18. Which environmental parameter is commonly monitored as part of IPQC for non-sterile solid dosage manufacturing?

• Sound level in decibels
• Temperature and relative humidity in production areas
• Operator hair length
• Traffic flow outside the facility

Correct Answer: Temperature and relative humidity in production areas

Q19. Which of the following best describes the relationship between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)?

• CQAs are manufacturing steps; CPPs are finished product tests
• CPPs must be controlled because they have a direct impact on CQAs
• CQAs and CPPs are unrelated concepts
• CPPs are only relevant for packaging

Correct Answer: CPPs must be controlled because they have a direct impact on CQAs

Q20. Which documentation practice is essential for effective IPQC and GMP compliance?

• Verbal instructions recorded only in operator memory
• Detailed, contemporaneous recording of in-process tests, deviations, and investigations
• Discard all in-process records after one week
• Minimal documentation to reduce paperwork

Correct Answer: Detailed, contemporaneous recording of in-process tests, deviations, and investigations

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