Finished product quality control tests MCQs With Answer are essential for B.Pharm students to master principles of pharmaceutical quality assurance. This set covers assay, identification, dissolution, disintegration, content uniformity, sterility, microbial limits, endotoxins, residual solvents, heavy metals, stability testing, and packaging integrity. Each question emphasizes pharmacopoeial methods, analytical techniques (HPLC, GC, UV), acceptance criteria, and interpretation of results. Practical aspects such as sampling, validation, instrument calibration, and troubleshooting are included to bridge theory and lab practice. Designed to build competence for regulatory compliance and batch release, these MCQs reinforce problem-solving and critical thinking for finished product quality control. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of finished product quality control testing?
- To develop new pharmaceutical formulations
- To ensure each batch meets predefined specifications for safety and efficacy
- To perform clinical trials on marketed products
- To optimize manufacturing throughput
Correct Answer: To ensure each batch meets predefined specifications for safety and efficacy
Q2. Which test is most appropriate to assess the rate at which a tablet releases its active drug in vitro?
- Disintegration test
- Dissolution test
- Assay by titration
- Friability test
Correct Answer: Dissolution test
Q3. For film-coated tablets, which test assesses physical durability under mechanical stress?
- Weight variation
- Content uniformity
- Friability
- Identification by IR
Correct Answer: Friability
Q4. Which analytical technique is most commonly used for quantitative assay of a drug substance with complex mixtures and low levels of impurities?
- Thin layer chromatography (TLC)
- UV-visible spectrophotometry
- High performance liquid chromatography (HPLC)
- Gravimetric analysis
Correct Answer: High performance liquid chromatography (HPLC)
Q5. Content uniformity testing is critical because it ensures:
- All units have identical weight
- Each unit contains the intended amount of active ingredient within narrow limits
- Coating thickness is uniform
- Dissolution is complete within 30 minutes
Correct Answer: Each unit contains the intended amount of active ingredient within narrow limits
Q6. Which finished product test specifically evaluates microbial contamination in non-sterile products?
- Sterility test
- Antimicrobial preservative efficacy test
- Microbial limit test
- Bacterial endotoxin test
Correct Answer: Microbial limit test
Q7. For parenteral products, which test is mandatory to ensure absence of viable microorganisms?
- Sterility test
- Microbial limit test
- Preservative efficacy
- pH measurement
Correct Answer: Sterility test
Q8. Which test detects and quantifies bacterial endotoxins in injectable products?
- Plate count
- Limulus Amebocyte Lysate (LAL) test
- Gram staining
- UV absorbance at 254 nm
Correct Answer: Limulus Amebocyte Lysate (LAL) test
Q9. Loss on drying (LOD) or Karl Fischer titration is used in finished product QC primarily to measure:
- Assay of active drug
- Residual solvent content
- Water content/moisture
- pH stability
Correct Answer: Water content/moisture
Q10. Which test helps determine whether tablets will break into smaller pieces under compressive force?
- Hardness test
- Friability test
- Disintegration test
- Assay
Correct Answer: Hardness test
Q11. In stability testing of finished products, accelerated conditions typically involve which combination?
- 5°C ±3°C
- 25°C/60% RH
- 40°C/75% RH
- 30°C/15% RH
Correct Answer: 40°C/75% RH
Q12. Residual solvent limits in a finished product are primarily evaluated by which technique?
- HPLC with UV detector
- Gas chromatography (GC)
- IR spectroscopy
- Atomic absorption spectroscopy
Correct Answer: Gas chromatography (GC)
Q13. The purpose of performing identification tests on finished products is to:
- Quantify impurities
- Confirm the presence of the declared active substance
- Measure dissolution rate
- Assess microbial quality
Correct Answer: Confirm the presence of the declared active substance
Q14. Which test is used to ensure uniform distribution of active ingredient within a semi-solid dosage form?
- pH measurement
- Content uniformity or assay of multiple samples
- Dissolution
- Friability
Correct Answer: Content uniformity or assay of multiple samples
Q15. For capsules, which test can be used as a surrogate for content uniformity in some pharmacopoeias?
- Weight variation test
- Dissolution test only
- Microbial limit test
- pH measurement
Correct Answer: Weight variation test
Q16. Which parameter is most directly related to the rate of bioavailability for oral solid dosage forms?
- Tablet color
- Dissolution profile
- Package label font
- Container closure integrity
Correct Answer: Dissolution profile
Q17. Which test evaluates the ability of a preservative system to inhibit microbial growth in a multi-dose aqueous formulation?
- Sterility test
- Preservative efficacy test (challenge test)
- Microbial limit test
- Bacterial endotoxin test
Correct Answer: Preservative efficacy test (challenge test)
Q18. Heavy metal contaminants in finished products are commonly screened by which technique?
- UV-visible spectrophotometry
- Atomic absorption spectroscopy (AAS) or ICP-MS
- HPLC-UV
- GC-FID
Correct Answer: Atomic absorption spectroscopy (AAS) or ICP-MS
Q19. Which test ensures that an ophthalmic solution is free from particulate matter visible to the naked eye?
- Particulate matter test for injectables
- pH test
- Color observation only
- Evaporation residue test
Correct Answer: Particulate matter test for injectables
Q20. Validation of an analytical method used in finished product testing should demonstrate which key parameters?
- Accuracy, precision, specificity, linearity, range, and robustness
- Only accuracy and color
- Only speed of analysis
- Only cost-effectiveness
Correct Answer: Accuracy, precision, specificity, linearity, range, and robustness
Q21. Which test would be used to detect undeclared organic volatile impurities in a finished capsule?
- Karl Fischer titration
- Gas chromatography (GC) for residual solvents
- Microbial limit test
- Melting point determination
Correct Answer: Gas chromatography (GC) for residual solvents
Q22. In a dissolution test, if the sample gives low drug release consistently across time points, the most likely causes include:
- Overfilled packaging
- Poor formulation dissolution properties, incorrect apparatus setup, or coating problems
- High pH of gastric fluid only
- Excessive friability
Correct Answer: Poor formulation dissolution properties, incorrect apparatus setup, or coating problems
Q23. Which finished product QC test is most relevant for lyophilized sterile products prior to reconstitution?
- Tablet hardness
- Residual moisture by Karl Fischer and sterility/endotoxin testing
- Color uniformity
- Friability
Correct Answer: Residual moisture by Karl Fischer and sterility/endotoxin testing
Q24. What is the main rationale for performing container closure integrity testing on sterile parenterals?
- To check label adhesion
- To confirm maintenance of sterility and protection from contamination
- To evaluate dissolution
- To measure pH changes
Correct Answer: To confirm maintenance of sterility and protection from contamination
Q25. Which test is used to confirm the identity of an active pharmaceutical ingredient in a finished product using molecular vibrations?
- Mass spectrometry
- IR (infrared) spectroscopy
- pH meter
- Microbial culture
Correct Answer: IR (infrared) spectroscopy
Q26. During finished product QC, out-of-specification (OOS) results should prompt which immediate action?
- Immediate batch release
- Investigation to identify root cause and assess impact on product quality
- Discard all records
- Ignore and retest indefinitely
Correct Answer: Investigation to identify root cause and assess impact on product quality
Q27. Which measurement is critical for sterile ophthalmic and parenteral formulations to ensure patient comfort and stability?
- Tablet hardness
- pH measurement
- Disintegration time
- Weight variation
Correct Answer: pH measurement
Q28. Which finished product QC parameter is most relevant to medications sensitive to light?
- Friability
- Light exposure testing and photostability studies
- Melting point analysis
- Viscosity only
Correct Answer: Light exposure testing and photostability studies
Q29. Which technique is preferred for quantifying trace levels of metallic impurities in a drug product?
- UV spectroscopy
- ICP-MS (Inductively Coupled Plasma – Mass Spectrometry)
- Thin layer chromatography
- pH titration
Correct Answer: ICP-MS (Inductively Coupled Plasma – Mass Spectrometry)
Q30. Which aspect of finished product QC ensures that analytical results are reliable and reproducible over time?
- Random sampling only
- Good laboratory practice including system suitability, calibration, reference standards, and documentation
- Using only one analyst for all tests
- Skipping method validation for speed
Correct Answer: Good laboratory practice including system suitability, calibration, reference standards, and documentation
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.
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