Introduction
Soft gelatin capsules are a common oral dosage form that require rigorous in-process and final quality control tests to ensure safety, potency, and performance. Key tests include fill weight determination, uniformity of dosage units, dissolution, assay (HPLC), moisture content (Karl Fischer), leak or seal integrity, shell hardness/elasticity, microbial limits, and stability. Understanding critical quality attributes (CQA) and critical process parameters (CPP) such as melt temperature, viscosity, and drying conditions is essential for B. Pharm students preparing for practical release and regulatory compliance. Mastering these tests helps ensure product quality, patient safety, and successful regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of in-process quality control for soft gelatin capsules?
- To design the capsule shell composition
- To monitor and control critical process parameters to ensure consistent quality
- To market the product effectively
- To determine the expiry date
Correct Answer: To monitor and control critical process parameters to ensure consistent quality
Q2. Which test directly measures the amount of active pharmaceutical ingredient in each soft gelatin capsule?
- Leakage test
- Assay (e.g., HPLC)
- Moisture content
- Shell viscosity
Correct Answer: Assay (e.g., HPLC)
Q3. For oil-filled soft gelatin capsules, which test is most critical to assess oxidation of oil-based actives?
- Viscosity measurement
- Peroxide value or rancidity test
- Water activity
- Disintegration test
Correct Answer: Peroxide value or rancidity test
Q4. Which in-process parameter most influences the fill weight accuracy of soft gelatin capsules?
- Drying temperature
- Rotary die alignment and dosing pump calibration
- Packaging speed
- Room lighting
Correct Answer: Rotary die alignment and dosing pump calibration
Q5. Which test is commonly used to detect shell leakage or compromised seals in soft gelatin capsules?
- Dye ingress or vacuum leak test
- Disintegration test
- pH test of shell film
- Uniformity of weight test
Correct Answer: Dye ingress or vacuum leak test
Q6. Which final quality control test evaluates the rate and extent of drug release from soft gelatin capsules?
- Assay by HPLC
- Dissolution testing
- Microbial limit test
- Hardness test of shell
Correct Answer: Dissolution testing
Q7. Uniformity of dosage units for soft gelatin capsules can be assessed by which of the following?
- Visual inspection only
- Weight variation or content uniformity depending on drug dose
- Moisture analysis only
- pH of fill material
Correct Answer: Weight variation or content uniformity depending on drug dose
Q8. What is the purpose of measuring moisture content in soft gelatin capsules?
- To determine capsule color
- To assess shell brittleness, stability, and potential microbial growth risk
- To measure API potency
- To evaluate packaging compatibility
Correct Answer: To assess shell brittleness, stability, and potential microbial growth risk
Q9. Which analytical method is most appropriate for quantifying low-level impurities in soft gelatin capsule formulations?
- UV spectrophotometry without separation
- Gas chromatography (GC) or HPLC with suitable detectors
- Simple titration
- Visual color comparison
Correct Answer: Gas chromatography (GC) or HPLC with suitable detectors
Q10. During in-process checks, which test ensures the gelatin mass has appropriate flow and forming characteristics?
- Viscosity measurement of gelatin melt
- Assay of API
- Microbial limit test
- Disintegration test
Correct Answer: Viscosity measurement of gelatin melt
Q11. What is the significance of seal integrity testing for soft gelatin capsules?
- It assesses shell color uniformity
- It ensures the fill is retained and prevents leakage or contamination
- It measures API potency
- It checks blister pack print quality
Correct Answer: It ensures the fill is retained and prevents leakage or contamination
Q12. Which test is NOT typically a final QC requirement for soft gelatin capsules?
- Dissolution test
- Uniformity of dosage units
- Disintegration time by tablet method
- Microbial limit test
Correct Answer: Disintegration time by tablet method
Q13. Which environmental condition is most critical to control during soft gelatin capsule manufacture and storage?
- Ambient noise
- Temperature and relative humidity
- Barometric pressure
- Room color
Correct Answer: Temperature and relative humidity
Q14. A routine in-process check for fill weight uniformity is performed because:
- It speeds up packaging
- It ensures each capsule contains the intended quantity of formulation
- It determines shell color
- It evaluates microbial safety
Correct Answer: It ensures each capsule contains the intended quantity of formulation
Q15. Which test assesses the potential for microbial contamination in soft gelatin capsules?
- Moisture content only
- Microbial limit test (bioburden) and sterility testing where applicable
- Assay by HPLC
- Viscosity of fill
Correct Answer: Microbial limit test (bioburden) and sterility testing where applicable
Q16. What is the role of extractables/leachables testing for soft gelatin capsule products?
- To measure capsule weight
- To evaluate compounds that may migrate from shell or packaging into the fill affecting safety or stability
- To determine dissolution profile
- To assess color uniformity
Correct Answer: To evaluate compounds that may migrate from shell or packaging into the fill affecting safety or stability
Q17. Which QC test monitors the mechanical properties of the gelatin shell such as elasticity and firmness?
- Texture analysis or puncture/firmness testing
- HPLC assay
- Microbial limit test
- Content uniformity
Correct Answer: Texture analysis or puncture/firmness testing
Q18. What is the preferred method to assess oil-filled capsule leakage in production scale?
- Visual inspection under white light only
- Online vacuum or dye intrusion inspection systems and periodic destructive testing
- pH measurement of shell only
- Measuring capsule color variance
Correct Answer: Online vacuum or dye intrusion inspection systems and periodic destructive testing
Q19. Which stability-indicating test is essential during long-term storage studies for soft gelatin capsules?
- Color matching
- Assay and degradation product profiling (stability-indicating HPLC)
- Package label verification
- Weight variation only
Correct Answer: Assay and degradation product profiling (stability-indicating HPLC)
Q20. In-process visual inspection mainly detects:
- API assay values
- Physical defects such as misshapen, stuck, or leaked capsules
- Moisture content precisely
- Viscosity of fill
Correct Answer: Physical defects such as misshapen, stuck, or leaked capsules
Q21. Why is filler oil viscosity analysis important for softgel filling?
- It determines shell color
- Viscosity affects pumpability, dose accuracy, and capsule filling performance
- It replaces the need for assay
- It predicts microbial contamination
Correct Answer: Viscosity affects pumpability, dose accuracy, and capsule filling performance
Q22. Which assay consideration is critical for content uniformity testing of low-dose potent drugs in soft gelatin capsules?
- Use of non-specific colorimetric methods
- Use of validated, sensitive analytical methods (e.g., LC-MS/MS or HPLC with appropriate sensitivity)
- Rely only on weight variation
- Only visual assessment
Correct Answer: Use of validated, sensitive analytical methods (e.g., LC-MS/MS or HPLC with appropriate sensitivity)
Q23. What is a typical acceptance rationale for dissolution testing of a softgel product?
- To ensure packaging aesthetics
- To demonstrate consistent and adequate in vitro release correlating to expected in vivo performance
- To measure microbial growth
- To assess shell thickness only
Correct Answer: To demonstrate consistent and adequate in vitro release correlating to expected in vivo performance
Q24. Which sampling plan is commonly used for QC testing of batches of soft gelatin capsules?
- Single unit from the batch
- Representative random sampling across the batch according to pharmacopeial or statistical plans
- Sampling only at the start of the run
- Sampling only from the final packaged cartons
Correct Answer: Representative random sampling across the batch according to pharmacopeial or statistical plans
Q25. Which factor most directly affects shell softening or tackiness during storage?
- API assay method
- Relative humidity and plasticizer migration
- Color of the shell
- Capsule packaging print
Correct Answer: Relative humidity and plasticizer migration
Q26. Which test helps detect volatile organic impurities from the fill or shell in soft gelatin capsules?
- Karl Fischer titration
- Headspace GC analysis
- Weight variation test
- Visual appearance
Correct Answer: Headspace GC analysis
Q27. How does the Karl Fischer titration contribute to QC for soft gelatin capsules?
- It measures the gelatin molecular weight
- It accurately determines water content (moisture) in shell or fill
- It measures API potency
- It tests seal integrity
Correct Answer: It accurately determines water content (moisture) in shell or fill
Q28. Which documentation is essential during in-process QC of softgel production?
- Only final label copy
- Batch manufacturing records, in-process test records, and deviation logs
- Only marketing brochures
- Only vendor invoices
Correct Answer: Batch manufacturing records, in-process test records, and deviation logs
Q29. Why are accelerated stability studies performed for soft gelatin capsules?
- To immediately approve the drug for sale
- To predict long-term stability and identify potential degradation pathways under stress conditions
- To test packaging design only
- To measure fill weight variability
Correct Answer: To predict long-term stability and identify potential degradation pathways under stress conditions
Q30. Which of the following is a critical control point to prevent microbial contamination during manufacture of soft gelatin capsules?
- Open windows in production area
- Controlled environment (cleanroom), proper GMP hygiene, and validated sanitization
- Using unfiltered air
- Storing raw materials at any temperature
Correct Answer: Controlled environment (cleanroom), proper GMP hygiene, and validated sanitization
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