In-process quality control tests are essential checks performed during pharmaceutical manufacturing to ensure product safety, efficacy and consistency. For B.Pharm students, mastering IPQC concepts—such as weight variation, content uniformity, dissolution, disintegration, hardness, friability, pH, microbial limits, moisture content, and particulate matter—is vital for compliant production and batch release. Understanding sampling plans, acceptance criteria, process validation, corrective actions, and instruments (e.g., dissolution apparatus, friabilator, hardness tester, HPLC) links theory to GMP practice. Familiarity with typical in-process parameters, PAT tools, and regulatory expectations (USP, ICH) prepares students for QC roles and audits. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of in-process quality control (IPQC) tests during manufacturing?
- To reduce manufacturing costs
- To ensure ongoing product quality and detect deviations
- To market the product faster
- To increase production speed
Correct Answer: To ensure ongoing product quality and detect deviations
Q2. Which test is commonly used to assess uniformity of weight in tablets during processing?
- Disintegration test
- Weight variation test
- Dissolution test
- Assay by HPLC
Correct Answer: Weight variation test
Q3. Which parameter is most relevant for assessing the mechanical strength of tablets?
- pH
- Hardness
- Viscosity
- Residual solvent level
Correct Answer: Hardness
Q4. Which in-process test evaluates a tablet’s tendency to break into powder during handling?
- Friability test
- Moisture content
- Assay
- Visual inspection
Correct Answer: Friability test
Q5. What does a dissolution test during manufacturing primarily measure?
- The tablet’s color stability
- The rate and extent of drug release
- Microbial contamination
- Particle size distribution
Correct Answer: The rate and extent of drug release
Q6. Which in-process control is critical for ensuring capsule fill uniformity?
- Disintegration time
- Blend uniformity / content uniformity
- pH measurement
- Friability
Correct Answer: Blend uniformity / content uniformity
Q7. During granulation, which parameter is monitored to determine end-point of wet granulation?
- Granule color
- Moisture content and granule size
- Tablet hardness
- pH of granules
Correct Answer: Moisture content and granule size
Q8. Which analytical technique is widely used for in-process assay of active pharmaceutical ingredients?
- Fourier transform infrared (FTIR)
- High-performance liquid chromatography (HPLC)
- Polarimetry
- Karl Fischer only
Correct Answer: High-performance liquid chromatography (HPLC)
Q9. What does “content uniformity” ensure in tablet production?
- Each tablet contains the labeled amount of API within specified limits
- All tablets dissolve within 5 minutes
- Tablets have consistent color
- All tablets have identical hardness
Correct Answer: Each tablet contains the labeled amount of API within specified limits
Q10. Which in-process test is especially important for sterile injectables?
- Friability
- Sterility and endotoxin (pyrogen) testing
- Weight variation
- Disintegration
Correct Answer: Sterility and endotoxin (pyrogen) testing
Q11. What does PAT stand for and why is it important in IPQC?
- Process Analytical Technology; for real-time monitoring and control
- Product Approval Test; for regulatory filing
- Pharmaceutical Assessment Tool; for marketing
- Parenteral Aseptic Technique; for sterilization
Correct Answer: Process Analytical Technology; for real-time monitoring and control
Q12. Which in-process check monitors moisture content accurately?
- Friabilator
- Karl Fischer titration
- Dissolution apparatus
- Disintegration tester
Correct Answer: Karl Fischer titration
Q13. For oral liquids, which in-process parameter must be checked frequently?
- Tablet hardness
- pH and viscosity
- Friability
- Disintegration
Correct Answer: pH and viscosity
Q14. What acceptance criterion term means “not less than” used in QC specifications?
- NMT (Not More Than)
- NLT (Not Less Than)
- ND (Not Detected)
- NDA (New Drug Application)
Correct Answer: NLT (Not Less Than)
Q15. Which in-process visual inspection detects defects like capping and lamination?
- In-process visual and mechanical inspection
- Karl Fischer test
- Endotoxin assay
- Microbial limit test
Correct Answer: In-process visual and mechanical inspection
Q16. Blend uniformity is most often assessed by which sampling approach?
- Single sample from the top only
- Multiple samples from different locations and composite analysis
- Only final tablet assay
- Visual inspection of the blender
Correct Answer: Multiple samples from different locations and composite analysis
Q17. Which instrument is used to measure tablet disintegration time during IPQC?
- Disintegration tester
- Friabilator
- Hardness tester
- pH meter
Correct Answer: Disintegration tester
Q18. What is the main reason to perform in-process pH checks for suspensions and solutions?
- To measure hardness
- To ensure chemical stability and solubility
- To count microbial colonies
- To determine particle size
Correct Answer: To ensure chemical stability and solubility
Q19. Which test detects sub-visible particles in parenteral products?
- Particulate matter test (light obscuration)
- Friability test
- Disintegration test
- pH test
Correct Answer: Particulate matter test (light obscuration)
Q20. In tablet compression, which in-process parameter is directly adjusted to control tablet hardness and thickness?
- Compression force (or turret force)
- pH of granules
- Ambient humidity only
- Dissolution medium
Correct Answer: Compression force (or turret force)
Q21. Which guideline is commonly referenced for pharmaceutical quality and in-process controls?
- ICH Q7 and USP standards
- FDA Dietary Guidelines
- CIDR for packaging only
- GMP for Veterinary products only
Correct Answer: ICH Q7 and USP standards
Q22. What does a friabilator measure in tablets?
- Chemical potency
- Weight loss due to abrasion
- Moisture gain
- Dissolution rate
Correct Answer: Weight loss due to abrasion
Q23. Why is in-process microbial monitoring critical in aseptic manufacturing?
- To increase yield
- To detect contamination early and prevent batch failure
- To reduce raw material cost
- To improve tablet hardness
Correct Answer: To detect contamination early and prevent batch failure
Q24. Which in-process test evaluates drying efficiency of granules?
- Residual moisture content
- Friability
- Compression force
- Disintegration
Correct Answer: Residual moisture content
Q25. Which parameter indicates proper lubrication in a tablet blend?
- Excessive dust only
- Tablet sticking and picking issues reduction
- Color change
- Increased microbial counts
Correct Answer: Tablet sticking and picking issues reduction
Q26. What is the role of in-process container closure integrity testing?
- To check batch number accuracy
- To ensure packaging prevents contamination and preserves product
- To measure pH
- To evaluate tablet hardness
Correct Answer: To ensure packaging prevents contamination and preserves product
Q27. Which test is performed in-process to assess the particle size distribution of powders?
- Particle size analysis (sieve or laser diffraction)
- Disintegration test
- Friability test
- Karl Fischer titration
Correct Answer: Particle size analysis (sieve or laser diffraction)
Q28. When IPQC shows out-of-specification (OOS) result, the first action should be:
- Release the batch immediately
- Investigate, quarantine batch and perform root cause analysis
- Discard all documentation
- Ignore and continue manufacturing
Correct Answer: Investigate, quarantine batch and perform root cause analysis
Q29. Which in-process control is crucial for ensuring flavor and stability in chewable tablets and syrups?
- Microbial limit test only
- pH, preservative efficacy and stability parameters
- Compression force only
- Friability only
Correct Answer: pH, preservative efficacy and stability parameters
Q30. What is the significance of sampling plans in IPQC?
- They are optional and rarely used
- They define how and how many samples are taken to ensure representative results
- They replace final release testing
- They only apply to packaging
Correct Answer: They define how and how many samples are taken to ensure representative results
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com