Concept of Quality Control and Quality Assurance MCQs With Answer

Concept of Quality Control and Quality Assurance MCQs With Answer

This collection of multiple-choice questions is specifically designed for M.Pharm students to deepen their understanding of Quality Control (QC) and Quality Assurance (QA) in pharmaceutical practice. The questions cover core concepts such as GMP, validation, stability, sampling plans, analytical method validation, OOS/OOT investigations, CAPA, change control, regulatory expectations (ICH/USP), and sterility assurance. Each item emphasizes practical application and critical thinking needed for batch release, documentation, and regulatory compliance. Use these MCQs to assess knowledge, prepare for exams, or stimulate discussion in seminars and journal clubs focused on maintaining product quality and patient safety.

Q1. What is the primary objective of Quality Assurance (QA) in a pharmaceutical manufacturing organization?

• To perform routine analytical testing of finished products
• To ensure processes and systems consistently produce products meeting predefined quality standards
• To reduce production costs by minimizing raw material usage
• To maximize batch throughput regardless of documentation

Correct Answer: To ensure processes and systems consistently produce products meeting predefined quality standards

Q2. Which of the following best describes Quality Control (QC)?

• A proactive system to manage change and continuous improvement
• An independent audit function that approves batch release
• The operational techniques and laboratory testing to verify product quality
• A regulatory body that enforces GMP

Correct Answer: The operational techniques and laboratory testing to verify product quality

Q3. Under ICH Q9, what is the main purpose of Quality Risk Management (QRM)?

• To replace all existing SOPs with risk-based procedures
• To prioritize resources by identifying and controlling potential quality risks to patients
• To eliminate the need for stability testing
• To standardize equipment across all manufacturing sites

Correct Answer: To prioritize resources by identifying and controlling potential quality risks to patients

Q4. Which parameter is NOT typically part of analytical method validation for an assay as per ICH Q2(R1)?

• Specificity
• Linearity
• Microbial bioburden
• Precision

Correct Answer: Microbial bioburden

Q5. What does OOS (Out Of Specification) primarily indicate?

• An analytical result that falls outside predefined acceptance criteria
• A batch that has passed all quality checks
• A minor labeling discrepancy
• A manufacturing process parameter trending within control limits

Correct Answer: An analytical result that falls outside predefined acceptance criteria

Q6. Which action is the most appropriate first step after obtaining an OOS result?

• Immediately release the batch with justification
• Discard all samples without investigation
• Initiate an OOS investigation following a documented procedure
• File a regulatory deviation without testing

Correct Answer: Initiate an OOS investigation following a documented procedure

Q7. In stability testing, what is the main reason for performing accelerated stability studies?

• To determine microbial contamination over decades
• To rapidly predict long-term stability by exposing product to elevated stress conditions
• To evaluate organoleptic properties only
• To replace real-time stability requirements entirely

Correct Answer: To rapidly predict long-term stability by exposing product to elevated stress conditions

Q8. Which document typically contains the acceptance criteria for release testing of a pharmaceutical batch?

• Purchase order
• Master Production Record (MPR)
• Product specification or specification sheet
• Employee training file

Correct Answer: Product specification or specification sheet

Q9. What is the role of Certificate of Analysis (CoA) in pharmaceutical QA/QC?

• To list supplier prices and purchase details
• To provide documented evidence that a specific lot meets defined specifications
• To act as the manufacturing batch record
• To replace stability studies for shelf-life determination

Correct Answer: To provide documented evidence that a specific lot meets defined specifications

Q10. Which statistical metric describes how well a process can produce output within specification limits?

• Standard deviation
• Cp and Cpk (process capability indices)
• Mean recovery
• Pearson correlation coefficient

Correct Answer: Cp and Cpk (process capability indices)

Q11. What is Change Control primarily intended to manage in a pharmaceutical quality system?

• Continuous minor adjustments with no documentation
• Planned or unplanned changes that may impact product quality, requiring evaluation and approval
• Employee vacation schedules
• Raw material invoice processing

Correct Answer: Planned or unplanned changes that may impact product quality, requiring evaluation and approval

Q12. Which guideline specifically addresses pharmaceutical quality systems and continuous improvement?

• ICH Q1A
• ICH Q10
• ICH Q2(R1)
• USP General Chapter only

Correct Answer: ICH Q10

Q13. In sterility assurance, what is the meaning of SAL (Sterility Assurance Level)?

• The maximum permitted level of endotoxin
• The probability of a single viable microorganism occurring on an item after sterilization
• A measure of disinfection contact time
• The dose of antibiotic used in media

Correct Answer: The probability of a single viable microorganism occurring on an item after sterilization

Q14. Which of the following is a key requirement for sampling plans in QC according to GMP principles?

• Samples should be randomly selected and representative of the batch
• Samples must always be taken from the first container only
• Sampling can be omitted if the batch is visually uniform
• All samples must be taken by the production operator without witnessing

Correct Answer: Samples should be randomly selected and representative of the batch

Q15. What is the main purpose of system suitability tests (SST) in chromatographic analysis?

• To replace calibration with standards
• To verify that the analytical system is functioning properly before sample analysis
• To measure dissolution only
• To assess packaging integrity

Correct Answer: To verify that the analytical system is functioning properly before sample analysis

Q16. Which regulatory expectation governs documentation of corrective and preventive actions (CAPA)?

• CAPA documentation is optional unless an audit requests it
• CAPA should be documented, investigated, and evaluated for effectiveness as part of a quality management system
• CAPA only applies to commercial products, not clinical supplies
• CAPA records should be kept only for one month

Correct Answer: CAPA should be documented, investigated, and evaluated for effectiveness as part of a quality management system

Q17. When an analytical method shows consistent bias during method validation, the most appropriate QA action is:

• Ignore the bias if precision is acceptable
• Investigate root causes, re-optimize the method, and revalidate affected parameters
• Release all batches tested using that method
• Switch to a different manufacturer’s reagents without documentation

Correct Answer: Investigate root causes, re-optimize the method, and revalidate affected parameters

Q18. Which of these best describes Out of Trend (OOT) results?

• Results that are outside specification limits
• Results that deviate from an established trend but remain within specification limits and require investigation
• Results that match historical averages exactly
• Results that are intentionally adjusted to meet specifications

Correct Answer: Results that deviate from an established trend but remain within specification limits and require investigation

Q19. In environmental monitoring of aseptic areas, what is the primary reason for monitoring both viable and non-viable particles?

• Non-viable particles are irrelevant and need not be monitored
• Viable monitoring indicates microbial contamination risk, while non-viable monitoring helps assess air cleanliness and potential sources for viable particles
• Only non-viable monitoring determines sterility
• To reduce the frequency of personnel monitoring

Correct Answer: Viable monitoring indicates microbial contamination risk, while non-viable monitoring helps assess air cleanliness and potential sources for viable particles

Q20. Which ICH guideline provides principles for pharmaceutical development and stability indicating methods used to support shelf-life?

• ICH Q3C
• ICH Q1A(R2)
• ICH Q8(R2)
• ICH Q5E

Correct Answer: ICH Q1A(R2)

Download