Introduction
This quiz collection on “Quality assurance functions in audit” is designed specifically for M.Pharm students preparing for advanced coursework and professional practice. The set focuses on the role of Quality Assurance (QA) within audit activities—covering audit planning, execution, reporting, follow-up, CAPA verification, data integrity checks, supplier and process audits, and regulatory inspection preparedness. Each question emphasizes the practical QA responsibilities during internal and external audits, interpretation of findings, root cause analysis, and implementation of corrective and preventive actions. Use these MCQs to deepen conceptual understanding, reinforce audit decision-making skills, and prepare for real-world pharmaceutical quality assurance challenges.
Q1. Which activity is a primary responsibility of Quality Assurance during an internal audit?
- Performing routine laboratory testing on all batches
- Planning and coordinating the audit schedule and scope
- Supervising production staff shifts
- Issuing purchase orders for raw materials
Correct Answer: Planning and coordinating the audit schedule and scope
Q2. During audit execution, what is the most appropriate method QA auditors should use to verify compliance?
- Rely solely on management statements
- Review documented procedures and observe actual operations
- Interview only senior management
- Conduct informal chats without documentation
Correct Answer: Review documented procedures and observe actual operations
Q3. Which document is essential for demonstrating an auditor’s independence and qualifications?
- Batch manufacturing record
- Auditor’s CV and declaration of independence
- Purchase requisition
- Daily production log
Correct Answer: Auditor’s CV and declaration of independence
Q4. What is the primary purpose of an audit checklist in a QA-led audit?
- To replace the need for auditor judgment
- To provide a structured framework ensuring consistent coverage of key areas
- To document employee attendance
- To act as a legal contract with suppliers
Correct Answer: To provide a structured framework ensuring consistent coverage of key areas
Q5. How should findings be classified in an audit report to reflect severity?
- Minor, Major, Critical
- Low, Medium, High
- Informal, Formal
- Resolved, Unresolved
Correct Answer: Minor, Major, Critical
Q6. After identifying a major nonconformity, what is the immediate QA function?
- Close the audit without further action
- Initiate containment, document the finding, and require a CAPA plan
- Terminate the employment of implicated staff
- Ignore until the next scheduled audit
Correct Answer: Initiate containment, document the finding, and require a CAPA plan
Q7. What is the role of QA in verifying the effectiveness of corrective actions?
- Approve CAPA without verification
- Perform verification activities and document evidence of effectiveness
- Delegate verification to production without oversight
- Only accept verbal assurance from departments
Correct Answer: Perform verification activities and document evidence of effectiveness
Q8. Which QA audit focuses on review of historical quality data, trends, and product quality review (PQR)?
- Supplier audit
- Combined regulatory inspection
- Systems and quality metrics audit (PQR/trend analysis)
- Environmental monitoring audit only
Correct Answer: Systems and quality metrics audit (PQR/trend analysis)
Q9. In supplier audits, what is a critical QA assessment point?
- Supplier’s cafeteria menu
- Supplier’s quality management system and raw material change control
- Number of parking spaces
- Local weather patterns
Correct Answer: Supplier’s quality management system and raw material change control
Q10. Which practice is essential for QA auditors when assessing data integrity?
- Assume data are accurate without review
- Examine audit trails, system controls, and data change logs
- Only review printed reports
- Check only signatures
Correct Answer: Examine audit trails, system controls, and data change logs
Q11. What is the significance of independence in QA audits?
- Independence is irrelevant if the auditor is busy
- Ensures impartial evaluation and avoids conflicts of interest
- Means auditors should work in production
- Requires auditors to approve CAPAs personally
Correct Answer: Ensures impartial evaluation and avoids conflicts of interest
Q12. Which audit type specifically evaluates compliance of laboratory operations and test methods?
- Financial audit
- Quality control (QC) laboratory audit
- Human resources audit
- Facility maintenance audit
Correct Answer: Quality control (QC) laboratory audit
Q13. What is an appropriate QA action when recurring minor deviations are observed across audits?
- Ignore since each is minor
- Perform root cause analysis and evaluate systemic causes
- Increase batch sizes to dilute deviations
- Change auditors each time
Correct Answer: Perform root cause analysis and evaluate systemic causes
Q14. When preparing an audit report, which element must QA ensure is included?
- Only positive comments
- Clear findings, evidence, risk impact, and agreed action items with timelines
- Employees’ personal contact details
- Unsubstantiated allegations without evidence
Correct Answer: Clear findings, evidence, risk impact, and agreed action items with timelines
Q15. How does a risk-based approach influence QA audit planning?
- Allocate equal audit frequency to all areas regardless of risk
- Prioritize audits and resources based on product/process risk and historical performance
- Eliminate audits for high-risk areas
- Audit only administrative departments
Correct Answer: Prioritize audits and resources based on product/process risk and historical performance
Q16. What is the QA role in sponsor or contract manufacturing organization (CMO) audits?
- Arrange social events only
- Define audit scope, verify contractual quality obligations, and assess GMP compliance
- Perform production activities for the CMO
- Approve invoices
Correct Answer: Define audit scope, verify contractual quality obligations, and assess GMP compliance
Q17. Which technique is valuable for QA auditors to gather objective evidence during interviews?
- Leading questions that suggest answers
- Open-ended and probing questions tied to documented procedures and observations
- Asking only yes/no questions
- Collecting anecdotal stories unrelated to processes
Correct Answer: Open-ended and probing questions tied to documented procedures and observations
Q18. For follow-up audits, what is a key QA consideration?
- Assume previous CAPAs are effective without review
- Verify implementation and effectiveness of previously agreed corrective actions
- Only check that the report was filed
- Change the audit scope completely
Correct Answer: Verify implementation and effectiveness of previously agreed corrective actions
Q19. Which regulatory expectation pertains to QA audit documentation?
- Audit documentation may be destroyed after one week
- Maintain traceable, complete, and readily retrievable audit records for the required retention period
- Allow undocumented verbal agreements to replace formal reports
- Store documentation only offsite without access
Correct Answer: Maintain traceable, complete, and readily retrievable audit records for the required retention period
Q20. In the context of audits, what best describes “audit trail review” performed by QA?
- Evaluation of historical weather data
- Review of electronic and manual records to ensure changes are authorized, dated, and attributable
- Checking employee lunch breaks
- Review only summaries without raw data
Correct Answer: Review of electronic and manual records to ensure changes are authorized, dated, and attributable
