Regulations related to quality control testing of dosage forms are essential for ensuring safety, efficacy, and consistent product quality in pharmaceutical manufacturing. B. Pharm students must understand regulatory frameworks such as pharmacopoeial standards, GMP, ICH guidelines, stability testing, analytical method validation, dissolution, assay, content uniformity, and batch release specifications. Practical knowledge of sampling plans, documentation, deviation handling, out-of-specification (OOS) procedures, and microbiological limits is equally important. This topic bridges theory and practice, preparing students for roles in QC laboratories, regulatory affairs, and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which regulatory document primarily provides monographs and official test methods for dosage form quality testing?
- Good Manufacturing Practice (GMP) Guidelines
- International Conference on Harmonisation (ICH) Guidelines
- Pharmacopoeia
- Quality Risk Management (QRM) Guidance
Correct Answer: Pharmacopoeia
Q2. What is the main purpose of analytical method validation in quality control?
- To reduce manufacturing costs
- To ensure the method is suitable, reliable, and reproducible for intended use
- To replace stability testing
- To speed up production
Correct Answer: To ensure the method is suitable, reliable, and reproducible for intended use
Q3. Which ICH guideline deals primarily with stability testing of new drug substances and products?
- ICH Q2(R1)
- ICH Q1A(R2)
- ICH Q3A
- ICH Q7
Correct Answer: ICH Q1A(R2)
Q4. For oral solid dosage forms, which test assesses the rate and extent of drug release?
- Assay
- Dissolution test
- Uniformity of dosage units
- Moisture content
Correct Answer: Dissolution test
Q5. Content uniformity testing is primarily used to evaluate which attribute?
- Microbial contamination
- Uniform distribution of active pharmaceutical ingredient among units
- Packaging integrity
- Particle size distribution
Correct Answer: Uniform distribution of active pharmaceutical ingredient among units
Q6. Which regulatory concept requires a documented system for managing deviations and CAPA?
- Good Laboratory Practice (GLP)
- Good Distribution Practice (GDP)
- Good Manufacturing Practice (GMP)
- Pharmacovigilance
Correct Answer: Good Manufacturing Practice (GMP)
Q7. In QC sampling, what does a representative sample ensure?
- That every container is tested
- That the sample reflects the true quality of the whole batch
- That testing is faster
- That only extremes of the batch are assessed
Correct Answer: That the sample reflects the true quality of the whole batch
Q8. What is an Out-of-Specification (OOS) result?
- A result within specification limits
- A result that falls outside established acceptance criteria and requires investigation
- An intentionally invalid test
- A method validation parameter
Correct Answer: A result that falls outside established acceptance criteria and requires investigation
Q9. Which parameter is NOT typically part of analytical method validation?
- Specificity
- Accuracy
- Market exclusivity
- Precision
Correct Answer: Market exclusivity
Q10. Which guideline provides principles for pharmaceutical quality systems and continuous improvement?
- ICH Q2(R1)
- EU Directive on pricing
- ICH Q10
- USP General Chapter on dissolution only
Correct Answer: ICH Q10
Q11. What is the primary regulatory concern for sterility testing of parenteral dosage forms?
- Color stability
- Microbial contamination
- Tablet hardness
- pH of packaging material
Correct Answer: Microbial contamination
Q12. Which test measures the API concentration in a finished product?
- Assay
- Disintegration
- Friability
- Visual inspection
Correct Answer: Assay
Q13. The term ‘specification’ in QC refers to:
- The manufacturing batch size
- Acceptance criteria for a test or attribute
- The shipping schedule
- The packaging artwork
Correct Answer: Acceptance criteria for a test or attribute
Q14. Which organization issues internationally recognized pharmacopoeial standards used in many countries?
- WHO, but pharmacopoeias include USP, BP, and Ph.Eur
- ISO only
- Local advertising agencies
- Drug distributors
Correct Answer: WHO, but pharmacopoeias include USP, BP, and Ph.Eur
Q15. What is the purpose of accelerated stability testing?
- To evaluate long-term market demand
- To predict long-term stability by stressing the product under elevated conditions
- To replace in-use stability studies
- To test packaging aesthetics
Correct Answer: To predict long-term stability by stressing the product under elevated conditions
Q16. Which concept assesses risks to product quality and prioritizes control measures?
- Quality Risk Management (QRM)
- Pharmacovigilance
- Good Distribution Practice (GDP)
- Market research
Correct Answer: Quality Risk Management (QRM)
Q17. What does GMP require regarding laboratory documentation?
- Loose, informal notes are acceptable
- Complete, accurate, and contemporaneous records with traceability
- Only electronic records without signatures
- No records are required for routine tests
Correct Answer: Complete, accurate, and contemporaneous records with traceability
Q18. Which test helps determine tablet mechanical strength during handling?
- Dissolution
- Hardness and friability
- Assay potency
- Microbial limit test
Correct Answer: Hardness and friability
Q19. In dissolution method development, which factor is commonly varied to optimize method performance?
- Tablet color
- Medium composition, paddle speed, and temperature
- Company logo placement
- Shipping route
Correct Answer: Medium composition, paddle speed, and temperature
Q20. Which of the following is a common acceptance criterion for microbial limits in non-sterile products?
- Zero colony forming units per gram for all products
- Specified maximum total aerobic microbial count and absence of specified pathogens
- Arbitrary values set by marketing
- Only pH requirements
Correct Answer: Specified maximum total aerobic microbial count and absence of specified pathogens
Q21. What is the role of batch release testing?
- To confirm the batch meets specifications before distribution
- To increase production time
- To reduce the number of stability studies
- To set pricing strategies
Correct Answer: To confirm the batch meets specifications before distribution
Q22. Which parameter indicates an analytical method’s ability to measure the analyte in presence of impurities and excipients?
- Linearity
- Specificity (selectivity)
- Range only
- Precision only
Correct Answer: Specificity (selectivity)
Q23. What is an Out-of-Trend (OOT) result?
- A result that matches previous data exactly
- A result that deviates from historical trends and may indicate a developing issue
- A result never documented
- A result within specification so no action needed
Correct Answer: A result that deviates from historical trends and may indicate a developing issue
Q24. Which regulatory procedure governs change control for manufacturing processes and specifications?
- Change control system under GMP and quality management
- Labeling only
- Advertising approvals
- Financial audits
Correct Answer: Change control system under GMP and quality management
Q25. Which stability-indicating attribute must a method demonstrate?
- Inability to detect degradation products
- Capability to separate and quantify active from its degradation products
- Only high sensitivity to excipients
- Only linearity at high concentrations
Correct Answer: Capability to separate and quantify active from its degradation products
Q26. What does ‘system suitability test’ verify before running QC assays?
- That marketing materials are ready
- That instrumental and chromatographic conditions are adequate for the analysis
- That the product is approved by regulators
- That only the API is present in raw material
Correct Answer: That instrumental and chromatographic conditions are adequate for the analysis
Q27. Which document defines the acceptance criteria and test methods for a specific drug product batch?
- Specification
- Personal resume
- Sales brochure
- Warehouse receipt
Correct Answer: Specification
Q28. Why is environmental monitoring important in sterile product manufacturing?
- To control the facility temperature for comfort only
- To monitor airborne and surface contamination that could compromise sterility
- To measure employee productivity
- To ensure the correct color of the walls
Correct Answer: To monitor airborne and surface contamination that could compromise sterility
Q29. Which test would commonly be used to assess the uniformity of weight in tablets?
- Uniformity of dosage units by weight variation
- Assay by HPLC only
- Sterility test
- Microbial limit test
Correct Answer: Uniformity of dosage units by weight variation
Q30. What action should be taken when QC detects a confirmed OOS result?
- Immediate destruction of the entire batch without investigation
- Initiate formal investigation, quarantine the batch, and document findings and corrective actions
- Ignore if within marketing timelines
- Release the batch if most tests pass
Correct Answer: Initiate formal investigation, quarantine the batch, and document findings and corrective actions
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