Administration of audits MCQs With Answer is a focused quiz resource designed for M.Pharm students preparing for professional exams and practical roles in quality assurance and regulatory affairs. This set covers the administration and management of audits, emphasizing planning, scope definition, audit charters, team selection, checklist development, sampling strategies, opening and closing meetings, report writing, classification of nonconformities, CAPA, follow‑up audits, supplier and computerized system audits, and regulatory inspection readiness. Each question probes both conceptual understanding and application in pharmaceutical contexts, helping students gain deeper insight into how audits support Good Manufacturing Practice (GMP) compliance and continual quality improvement.
Q1. What is the primary objective of conducting a quality audit in a pharmaceutical facility?
- To evaluate compliance with regulatory and quality requirements
- To train production staff on new procedures
- To determine market demand for a new product
- To finalize annual financial reports
Correct Answer: To evaluate compliance with regulatory and quality requirements
Q2. What is the first activity in the audit planning phase?
- Issuing the final audit report
- Defining audit scope and objectives
- Sampling finished product batches
- Scheduling the closing meeting
Correct Answer: Defining audit scope and objectives
Q3. Which document formally authorizes and defines the overall audit program and its authority?
- Audit checklist
- Audit charter
- Corrective action plan
- Training matrix
Correct Answer: Audit charter
Q4. Which sampling approach is most aligned with modern pharmaceutical auditing practices?
- Random sampling without risk consideration
- Risk‑based sampling focused on critical processes
- Sampling only finished product lots
- Sampling based solely on production date
Correct Answer: Risk‑based sampling focused on critical processes
Q5. Who typically approves the overall annual audit plan within a pharmaceutical organization?
- Audit program manager
- Production supervisor
- Sales director
- External consultant
Correct Answer: Audit program manager
Q6. What is the main purpose of the opening meeting at the start of an audit?
- To perform sampling of raw materials
- To communicate scope, objectives and logistics to auditee
- To finalize corrective actions
- To issue certificates of conformity
Correct Answer: To communicate scope, objectives and logistics to auditee
Q7. Which element must be included in an effective audit checklist for GMP audits?
- References to applicable regulatory requirements and standards
- Company marketing strategies
- Employee salary details
- Product pricing information
Correct Answer: References to applicable regulatory requirements and standards
Q8. How are observed issues commonly classified in pharmaceutical audits?
- Critical, Routine, Informational
- Major, Minor and Observation
- High, Medium, Low based on cost only
- Administrative and Non‑administrative
Correct Answer: Major, Minor and Observation
Q9. Who is normally responsible for compiling and issuing the final audit report?
- Lead auditor
- Plant manager
- Quality control analyst
- Human resources officer
Correct Answer: Lead auditor
Q10. What is a commonly accepted timeframe for issuing a formal audit report after fieldwork completion?
- Within 48 hours
- Within 10 working days
- Within 90 calendar days
- Only at the next annual review
Correct Answer: Within 10 working days
Q11. What is the primary purpose of a Corrective and Preventive Action (CAPA) process following an audit?
- To punish staff responsible for nonconformities
- To correct root causes and prevent recurrence
- To document financial losses from deviations
- To increase production targets
Correct Answer: To correct root causes and prevent recurrence
Q12. What is the main objective of a follow‑up audit?
- To select new suppliers
- To verify implementation and effectiveness of CAPAs
- To renegotiate contracts
- To validate new analytical methods
Correct Answer: To verify implementation and effectiveness of CAPAs
Q13. What is an important confidentiality measure for audit administration?
- Sharing audit findings on social media
- Signing non‑disclosure agreements for audit team members
- Publishing raw audit notes externally
- Allowing unrestricted photos of documents
Correct Answer: Signing non‑disclosure agreements for audit team members
Q14. Which statement best distinguishes a regulatory inspection from an internal audit?
- Inspections are informal conversations with staff
- Inspections are conducted by regulators with legal authority
- Internal audits always result in fines
- Inspections focus only on marketing materials
Correct Answer: Inspections are conducted by regulators with legal authority
Q15. When auditing a supplier, what is the primary focus?
- Supplier’s marketing strategy
- Supplier’s quality system and compliance to GMP
- Supplier’s employee turnover rate only
- Supplier’s retail pricing policy
Correct Answer: Supplier’s quality system and compliance to GMP
Q16. What does an audit trail in a computerized system provide?
- A chronological record of system access and data changes
- The marketing history of a product
- Employee personal opinions about processes
- Financial transaction summaries only
Correct Answer: A chronological record of system access and data changes
Q17. Which root cause analysis technique is commonly used during audit investigations?
- Random guessing
- Fishbone (Ishikawa) diagram and 5 Whys
- Only reviewing the audit checklist
- Relying solely on external consultants
Correct Answer: Fishbone (Ishikawa) diagram and 5 Whys
Q18. Which metric is useful for measuring the performance of an audit program?
- Number of product launches per year
- Audit closure rate and time to close CAPAs
- Number of marketing campaigns
- Employee cafeteria usage
Correct Answer: Audit closure rate and time to close CAPAs
Q19. What is the main purpose of conducting a mock regulatory inspection?
- To train sales staff on product features
- To prepare the organization for actual regulatory inspections
- To increase production speed
- To update pricing strategies
Correct Answer: To prepare the organization for actual regulatory inspections
Q20. When is a re‑audit typically necessary?
- After a major nonconformity to verify CAPA effectiveness
- Only when a new building is constructed
- Every month regardless of findings
- When the marketing team requests one
Correct Answer: After a major nonconformity to verify CAPA effectiveness
