Types of audits, audit process and FDA inspection preparedness MCQs With Answer

Types of audits, audit process and FDA inspection preparedness MCQs With Answer

Introduction: This quiz collection is designed for M.Pharm students studying Clinical Research (MPP 104T) to deepen understanding of audits, the audit lifecycle, and FDA inspection preparedness. The questions cover audit types (internal, sponsor, regulatory, supplier), detailed steps of audit planning and execution, recording findings and CAPA, and regulatory expectations such as 21 CFR, ICH GCP and Part 11 for electronic records. Practical inspection readiness topics include mock inspections, responding to Form FDA 483, documentation retention, and site/sponsor responsibilities. Use these MCQs to test knowledge, identify learning gaps, and reinforce procedures needed to maintain compliance in clinical research and pharmaceutical operations.

Q1. Which of the following lists best represents common types of audits relevant to clinical research and pharmaceutical quality systems?

• Internal, External, Regulatory and Supplier audits
• Financial, Marketing, IT and Sales audits
• Product Release, Packaging, Promotion and Distribution audits
• Patient Satisfaction, Epidemiology, Clinical and Environmental audits

Correct Answer: Internal, External, Regulatory and Supplier audits

Q2. What is the correct initial phase of a formal audit process?

• Opening meeting with auditee
• Audit planning and preparation
• Issuing the audit report
• Conducting corrective actions

Correct Answer: Audit planning and preparation

Q3. The primary purpose of the opening meeting in an audit is to:

• Present final audit findings and corrective actions
• Review scope, objectives, logistics and confirm key contacts
• Train staff on CAPA procedures
• Require immediate document revisions

Correct Answer: Review scope, objectives, logistics and confirm key contacts

Q4. Which guidance document enumerates the essential documents to be maintained for clinical trials?

• ICH E6 (Good Clinical Practice)
• FDA 21 CFR Part 820
• ICH Q7 (API GMP)
• ICH Q1A (Stability)

Correct Answer: ICH E6 (Good Clinical Practice)

Q5. Which FDA form is issued to document investigator or firm observations at the conclusion of an inspection?

• Form FDA 483 (Inspectional Observations)
• Form FDA 1572
• Establishment Inspection Report (EIR)
• Warning Letter

Correct Answer: Form FDA 483 (Inspectional Observations)

Q6. In audit terminology CAPA stands for:

• Corrective and Preventive Action
• Control and Product Assessment
• Compliance and Procedure Audit
• Corrective Audit Process Action

Correct Answer: Corrective and Preventive Action

Q7. Which regulation specifically addresses electronic records and electronic signatures in FDA-regulated industries?

• 21 CFR Part 11
• 21 CFR Part 210
• 21 CFR Part 312
• 21 CFR Part 58

Correct Answer: 21 CFR Part 11

Q8. What is the commonly recommended timeframe for a formal written response to an FDA Form 483?

• 15 business days
• 7 calendar days
• 90 days
• One year

Correct Answer: 15 business days

Q9. Which of the following is NOT part of the ALCOA+ principles for data integrity?

• Attributable
• Legible
• Compliant
• Original

Correct Answer: Compliant

Q10. A practical and effective step to improve FDA inspection preparedness is to:

• Conduct regular mock inspections and document walkthroughs
• Erase old audit records to simplify review
• Limit staff training to managers only
• Wait for the FDA to provide inspection checklists

Correct Answer: Conduct regular mock inspections and document walkthroughs

Q11. Who holds primary responsibility for overall monitoring and oversight of investigator sites in a clinical trial?

• The study sponsor
• The Institutional Review Board only
• The drug distributor
• The local hospital administration

Correct Answer: The study sponsor

Q12. What does the FDA term EIR stand for in inspection reporting?

• Establishment Inspection Report
• External Inspection Review
• Electronic Inspection Record
• Enforcement Inspection Record

Correct Answer: Establishment Inspection Report

Q13. Which 21 CFR parts contain the current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals?

• 21 CFR Parts 210 and 211
• 21 CFR Part 11 only
• 21 CFR Part 312
• 21 CFR Parts 600 and 610

Correct Answer: 21 CFR Parts 210 and 211

Q14. An audit trail in an electronic system should provide which of the following?

• A chronological record of who made changes and when
• A summary of marketing activities
• A list of supplier invoices only
• An inventory count without timestamps

Correct Answer: A chronological record of who made changes and when

Q15. Audit findings are commonly categorized into which severity levels?

• Critical, Major and Minor
• High, Medium, Low and Zero
• Type I, Type II and Type III
• Acceptable, Conditional and Rejected

Correct Answer: Critical, Major and Minor

Q16. Which type of FDA inspection is most likely to be unannounced and triggered by specific concerns?

• For-cause inspection
• Pre-approval inspection
• Routine surveillance inspection
• Annual registration inspection

Correct Answer: For-cause inspection

Q17. A complete audit report should always include which of the following elements?

• Observed findings with evidence, root cause analysis and recommended CAPA
• Only a pass/fail statement without details
• Financial implications of findings only
• Staff performance reviews unrelated to audit scope

Correct Answer: Observed findings with evidence, root cause analysis and recommended CAPA

Q18. According to ICH GCP, clinical trial essential documents should generally be retained for at least how long after the last marketing approval in an ICH region?

• 2 years after the last approval
• 6 months after trial completion
• 25 years regardless of approval status
• Until the investigator changes institutions

Correct Answer: 2 years after the last approval

Q19. If an FDA investigator requests immediate access to trial records during an inspection, the most appropriate immediate action is to:

• Allow access to requested records per SOP and notify QA/regulatory immediately
• Refuse access until the sponsor provides written permission
• Delete irrelevant files to speed up the review
• Delay access and ask the inspector to return on another day

Correct Answer: Allow access to requested records per SOP and notify QA/regulatory immediately

Q20. Which factor is the best single indicator that a clinical research site or pharmaceutical facility is inspection-ready?

• Consistent, well-organized documentation, trained staff and completed CAPAs demonstrated by mock inspections
• Having no prior audit history
• Only senior management knowing where records are kept
• Keeping records offsite without access procedures

Correct Answer: Consistent, well-organized documentation, trained staff and completed CAPAs demonstrated by mock inspections

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