What this round covers
- Self-inspection programmes
- Regulatory inspection readiness
- Form 483 and Warning Letter responses
- Vendor and contract-site audits
- Observation classification and CAPA
10 Audits & Compliance interview questions with answers
- Q1Self-InspectionBeginner
What is the primary purpose of an internal self-inspection programme?
Model answer: Self-inspections proactively find and correct compliance gaps before external inspections or failures occur.
- Proactive detection
- Independent auditors
- CAPA tracking
- Q2Self-InspectionBeginner
EU GMP Chapter 9 requires self-inspection frequency to be:
Model answer: A documented self-inspection programme with a defined schedule, usually annual, is required under EU GMP.
- Documented schedule
- Trained auditors
- Follow-up CAPA
- Q3Self-InspectionBeginner
Who should ideally conduct a self-inspection of a department?
Model answer: Independence ensures objectivity; auditors should not review their own area of direct responsibility.
- Independence
- Competence/training
- Objectivity
- Q4Mock AuditsIntermediate
A mock regulatory inspection primarily helps to:
Model answer: Mock audits simulate a real inspection to test readiness, front/back room processes and staff behaviour.
- Simulates real inspection
- Staff behaviour training
- Gap closure before actual audit
- Q5Vendor AuditsIntermediate
Vendor audits for contract manufacturers should be scheduled based on:
Model answer: Risk-based audit scheduling considers material/product criticality, past performance and regulatory risk.
- Risk ranking
- Criticality of supply
- Audit frequency justified
- Q6Vendor AuditsIntermediate
A Quality Agreement with a contract manufacturer should define:
Model answer: Quality agreements delineate GMP responsibilities, change notification, deviation handling and audit rights.
- Responsibility matrix
- Change notification
- Audit rights
- Q7Inspection ClassificationBeginner
Which classification does the USFDA use to describe an inspection with no objectionable observations?
Model answer: NAI (No Action Indicated) means no objectionable conditions were found warranting further action.
- No 483 issued
- Lowest risk classification
- Still may get EIR
- Q8Inspection ClassificationIntermediate
VAI classification means:
Model answer: VAI indicates objectionable conditions were found but do not warrant regulatory action if voluntarily corrected.
- Voluntary correction expected
- 483 may be issued
- No warning letter typically
- Q9Inspection ClassificationAdvanced
OAI classification can lead to:
Model answer: Official Action Indicated triggers formal regulatory consequences such as warning letters or import alerts.
- Regulatory consequences
- Delayed approvals
- Consent decree possible
- Q10Form 483Beginner
A Form 483 is issued when:
Model answer: Form 483 lists objectionable conditions observed by the FDA investigator at inspection close-out.
- Issued at close-out
- Not a final agency determination
- Requires timely response
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