Audit tools and GLP inspection process MCQs With Answer

Audit tools and GLP inspection process MCQs With Answer

This quiz set is designed for M.Pharm students to deepen understanding of audit tools and the Good Laboratory Practice (GLP) inspection process. It covers practical audit techniques (checklists, interviews, sampling, and document review), GLP-specific requirements (study plans, raw data integrity, QA unit responsibilities), and inspector interactions (pre-inspection, opening/close-out meetings, and observation classification). Questions focus on applying regulatory expectations to real-world non-clinical laboratory settings, identifying common deficiencies, and selecting appropriate corrective and preventive actions. These MCQs will help students prepare for regulatory roles, internal QA responsibilities, and inspections by emphasizing analytical thinking and detailed familiarity with GLP principles.

Q1. Which audit tool is most effective for systematically verifying compliance against a predefined set of GLP requirements during a facility walkthrough?

• Process flow diagram
• Structured checklist
• Root cause analysis report
• Management review minutes

Correct Answer: Structured checklist

Q2. During a GLP inspection, which document is essential for demonstrating the planned conduct and specific procedures of a non-clinical study?

• Study plan (protocol)
• Validation summary
• Training matrix
• Instrument logbook

Correct Answer: Study plan (protocol)

Q3. Which audit technique best uncovers discrepancies between what staff say they do and what is recorded in laboratory records?

• Statistical process control
• Direct observation
• Document trend analysis
• Supplier audits

Correct Answer: Direct observation

Q4. In GLP inspections, the QA unit is primarily responsible for which of the following?

• Performing the study as study director
• Conducting objective audits to ensure compliance
• Providing test article to the sponsor
• Authorizing budgets for animal procurement

Correct Answer: Conducting objective audits to ensure compliance

Q5. Which tool helps an auditor prioritize inspection focus by identifying high-risk processes or studies?

• Fishbone diagram
• Risk assessment matrix
• Meeting attendance sheet
• Archiving schedule

Correct Answer: Risk assessment matrix

Q6. What is the inspector’s primary purpose during the opening meeting of a GLP inspection?

• To issue citations immediately
• To review preliminary findings
• To outline the scope, objectives and logistics of the inspection
• To take custody of all raw data

Correct Answer: To outline the scope, objectives and logistics of the inspection

Q7. Which of the following is considered raw data in a GLP study?

• Final study report summary
• Original instrument printouts and notebooks
• Internal audit schedule
• Marketing authorization application

Correct Answer: Original instrument printouts and notebooks

Q8. What is the most appropriate auditor action when encountering an undocumented deviation observed during a study?

• Ignore it if results seem unaffected
• Discuss candidly with staff and request documented deviation and CAPA
• Seize all study files immediately
• Delay action until the close-out meeting

Correct Answer: Discuss candidly with staff and request documented deviation and CAPA

Q9. During GLP inspection, which evidence best demonstrates data integrity for computerized systems?

• Handwritten copies of electronic results only
• System user access logs, audit trails, and validation records
• Marketing materials referencing software
• Purchase invoices for software

Correct Answer: System user access logs, audit trails, and validation records

Q10. Which classification of inspection finding indicates a deficiency that could significantly affect the validity of study results?

• Observation
• Minor nonconformity
• Major nonconformity
• Informational note

Correct Answer: Major nonconformity

Q11. What audit tool is particularly helpful for tracing interactions and responsibilities across different functional units in a GLP facility?

• Control chart
• Responsibility (RACI) matrix
• Temperature map
• Trend histogram

Correct Answer: Responsibility (RACI) matrix

Q12. Which practice is essential for ensuring long-term accessibility and integrity of study records in GLP?

• Temporary off-site storage without tracking
• Secure archiving with controlled access and retrieval procedures
• Scanning and discarding originals immediately
• Relying solely on investigators’ personal copies

Correct Answer: Secure archiving with controlled access and retrieval procedures

Q13. In a GLP inspection, an auditor requests to interview the study director. What is the most appropriate expectation from the study director?

• Declining the interview due to busy schedule
• Providing clear, transparent answers and access to relevant records
• Directing the inspector to speak only with QA
• Withholding information until legal counsel is present

Correct Answer: Providing clear, transparent answers and access to relevant records

Q14. Which audit tool is used to identify potential root causes of recurring GLP deviations?

• Control plan
• Root cause analysis (e.g., 5 Whys, fishbone)
• Audit schedule
• Quality manual index

Correct Answer: Root cause analysis (e.g., 5 Whys, fishbone)

Q15. When an inspector finds missing signed entries in animal welfare logs, the deficiency most directly impacts which GLP principle?

• Facility aesthetics
• Data reproducibility
• Traceability and record completeness
• Marketing compliance

Correct Answer: Traceability and record completeness

Q16. Which element should be included in a post-audit corrective and preventive action (CAPA) plan to satisfy inspectors?

• Only verbal commitments
• Root cause, corrective actions, timelines, responsible persons, and verification steps
• Immediate staff termination list
• Unspecified future review date

Correct Answer: Root cause, corrective actions, timelines, responsible persons, and verification steps

Q17. For GLP compliance, how long should study raw data generally be retained after study completion (subject to local regulations)?

• Until the next audit only
• Typically for the lifetime of the product or as specified by regulations (often several years)
• One month after study report
• Only while the study is active

Correct Answer: Typically for the lifetime of the product or as specified by regulations (often several years)

Q18. Which pre-inspection activity by a facility can facilitate a smoother GLP inspection?

• Hiding known deficiencies
• Preparing a clear master list of ongoing studies, locations of records, and key contacts
• Requesting the inspector to focus only on positive items
• Deleting redundant records

Correct Answer: Preparing a clear master list of ongoing studies, locations of records, and key contacts

Q19. When auditing chemical inventory control in a GLP lab, which observation would raise the most concern to an inspector?

• Comprehensive MSDS available and current
• Unlabeled containers and missing receipt records
• Segregated hazardous storage
• Periodic reconciliation logs

Correct Answer: Unlabeled containers and missing receipt records

Q20. Which practice demonstrates effective use of audit findings to drive continuous GLP improvement?

• Filing findings without follow-up
• Implementing CAPA, verifying effectiveness, and updating procedures and training
• Ignoring minor findings permanently
• Replacing staff without addressing systemic issues

Correct Answer: Implementing CAPA, verifying effectiveness, and updating procedures and training

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