Quality Control (QC) and Quality Assurance (QA) are fundamental to pharmaceutical quality management. QC focuses on analytical testing, sampling, in‑process controls and batch release to verify product quality, while QA establishes the systems, SOPs, documentation, GMP and oversight that prevent defects and ensure regulatory compliance. B.Pharm students should grasp validation types, method validation, calibration, stability testing, deviation/OOS handling, CAPA, root cause analysis, statistical quality control and pharmacopoeial standards (USP/IP/ICH). Strong understanding of QC/QA principles, tools and workflows prepares you for industry roles and inspections. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary goal of Quality Assurance (QA) in the pharmaceutical industry?
- To perform routine analytical testing on finished products
- To ensure systems and processes prevent defects and maintain compliance
- To calculate shelf life using statistical models
- To design marketing strategies for new drugs
Correct Answer: To ensure systems and processes prevent defects and maintain compliance
Q2. Which activity is typically classified under Quality Control (QC)?
- Developing company SOPs for production
- Conducting microbiological testing of a batch
- Approving supplier quality agreements
- Managing internal audits
Correct Answer: Conducting microbiological testing of a batch
Q3. Which document defines step-by-step operations for routine tasks in a pharmaceutical unit?
- Batch production record
- Standard Operating Procedure (SOP)
- Validation master plan
- Quality policy statement
Correct Answer: Standard Operating Procedure (SOP)
Q4. What does OOS stand for in QC terminology?
- Optimal On-site Sampling
- Out of Specification
- Operational Oversight System
- Official Observational Study
Correct Answer: Out of Specification
Q5. Which guideline primarily provides international standards for pharmaceutical quality?
- ICH (International Council for Harmonisation)
- FDA Food Code
- CFR Title 21 Part 11 exclusively
- ISO 14001
Correct Answer: ICH (International Council for Harmonisation)
Q6. Which of the following is a preventive QA activity?
- Releasing a batch after test results
- Conducting supplier audits prior to qualification
- Performing a stability study
- Investigating an OOS result
Correct Answer: Conducting supplier audits prior to qualification
Q7. What is the primary purpose of method validation in QC?
- To reduce manufacturing costs
- To demonstrate that an analytical method is suitable for its intended purpose
- To train staff on equipment use
- To establish marketing claims
Correct Answer: To demonstrate that an analytical method is suitable for its intended purpose
Q8. Which type of validation ensures consistent performance of a manufacturing process?
- Analytical method validation
- Cleaning validation
- Process validation
- Software validation
Correct Answer: Process validation
Q9. CAPA in QA stands for:
- Corrective and Preventive Actions
- Control and Process Automation
- Compliance Assessment of Product Attributes
- Critical Analytical Performance Assessment
Correct Answer: Corrective and Preventive Actions
Q10. Which is a critical component of a stability study?
- Marketing timeline
- Long-term and accelerated storage conditions
- Color preference surveys
- Packaging design only
Correct Answer: Long-term and accelerated storage conditions
Q11. What is an In-Process Control (IPC)?
- A final release test performed after packaging
- A check performed during manufacturing to monitor process parameters
- A financial audit of quality expenses
- A stability test under accelerated conditions
Correct Answer: A check performed during manufacturing to monitor process parameters
Q12. Which regulatory concept requires traceable, contemporaneous documentation of all production steps?
- Batch record maintenance
- Product marketing
- Sales forecasting
- Customer feedback collection
Correct Answer: Batch record maintenance
Q13. Root cause analysis in QA is used to:
- Determine market demand for a drug
- Identify underlying reasons for deviations or failures
- Calculate assay limits in an HPLC method
- Write SOPs for office administration
Correct Answer: Identify underlying reasons for deviations or failures
Q14. Which statistical tool is commonly used in QC to monitor process stability?
- Control charts (e.g., Shewhart chart)
- Pareto analysis for marketing
- ANOVA for clinical trials only
- SWOT analysis
Correct Answer: Control charts (e.g., Shewhart chart)
Q15. What does GMP primarily ensure in pharmaceutical manufacturing?
- That production is cost-effective
- That products are consistently produced and controlled to quality standards
- That marketing is effective across regions
- That clinical trials are successful
Correct Answer: That products are consistently produced and controlled to quality standards
Q16. Which of the following is an example of documentation required by QA?
- Employee personal performance reviews only
- Validated cleaning records and equipment logs
- Marketing brochures
- Customer satisfaction survey results only
Correct Answer: Validated cleaning records and equipment logs
Q17. The acceptance criteria for a QC test are usually based on:
- Arbitrary management decisions
- Regulatory requirements and product specifications
- Competitor product colors
- Supplier pricing
Correct Answer: Regulatory requirements and product specifications
Q18. Which type of validation assesses removal of contaminants between manufacturing campaigns?
- Process validation
- Cleaning validation
- Method validation
- Packaging validation
Correct Answer: Cleaning validation
Q19. What is the correct response when a QC analyst obtains an OOS result?
- Immediately release the batch to meet deadlines
- Initiate an investigation following established SOPs
- Ignore and retest without documentation
- Cancel all related records permanently
Correct Answer: Initiate an investigation following established SOPs
Q20. Which pharmacopoeial reference is often used for QC specifications?
- USP (United States Pharmacopeia)
- ISO 9001 exclusively
- ICH Q14 only
- SOP on office cleaning
Correct Answer: USP (United States Pharmacopeia)
Q21. Which QA function evaluates compliance through scheduled assessments?
- Internal audits
- Marketing analysis
- Clinical monitoring
- Sales visits
Correct Answer: Internal audits
Q22. What does “validation master plan” describe?
- A schedule and strategy for validation activities across a facility
- A marketing plan for validated products
- An employee hiring plan
- A list of approved suppliers only
Correct Answer: A schedule and strategy for validation activities across a facility
Q23. Which is an example of an attribute test in QC?
- Measuring tablet weight variation
- Estimating market share
- Assessing employee satisfaction
- Counting number of production employees
Correct Answer: Measuring tablet weight variation
Q24. The purpose of calibration is to:
- Adjust production schedules
- Verify and adjust instrument accuracy against standards
- Create marketing materials
- Train QC staff in writing SOPs
Correct Answer: Verify and adjust instrument accuracy against standards
Q25. Which term describes unexpected deviations that may affect product quality?
- Planned deviations
- Nonconformities or deviations
- Marketing variances
- Financial discrepancies
Correct Answer: Nonconformities or deviations
Q26. Which document authorizes release of a pharmaceutical batch?
- Quality control test reports only
- Certificate of analysis and QA batch release
- Sales order
- Purchase order
Correct Answer: Certificate of analysis and QA batch release
Q27. What is the significance of “traceability” in QA documentation?
- It ensures marketing claims are traceable to research
- It allows linking of each record to responsible personnel and actions
- It restricts access to only top management
- It documents supplier pricing history
Correct Answer: It allows linking of each record to responsible personnel and actions
Q28. Which QA practice helps manage risk to product quality?
- Risk assessment and control (e.g., FMEA)
- Ignoring minor deviations
- Reducing documentation
- Advertising to increase sales
Correct Answer: Risk assessment and control (e.g., FMEA)
Q29. Analytical specificity in method validation refers to:
- The method’s ability to assess one analyte in presence of others
- How fast the method runs
- Cost efficiency of the method
- Number of operators needed
Correct Answer: The method’s ability to assess one analyte in presence of others
Q30. Which is a key outcome of a robust QA system?
- Higher advertising spend
- Consistent product quality and regulatory compliance
- Reduced laboratory testing
- Elimination of all deviations
Correct Answer: Consistent product quality and regulatory compliance
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