Laboratory control system inspection MCQs With Answer

Introduction: This collection of Laboratory Control System Inspection MCQs with answers is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T). The questions focus on practical and regulatory aspects of laboratory control systems, including documentation, equipment qualification, calibration, data integrity, sampling, reagent management, stability testing, and inspection readiness. Each MCQ probes deeper into inspection criteria, investigator responsibilities, and common findings during regulatory audits. Practicing these MCQs will help reinforce critical concepts, improve interpretative skills for real-world laboratory scenarios, and prepare students for examinations and professional roles in quality control, quality assurance, and regulatory affairs within pharmaceutical laboratories.

Q1. What is the primary objective of a laboratory control system during regulatory inspection?

• To maximize laboratory throughput irrespective of documentation
• To ensure analytical methods are changed frequently
• To ensure the reliability, integrity, and traceability of test results
• To reduce the number of qualified personnel

Correct Answer: To ensure the reliability, integrity, and traceability of test results

Q2. Which document should describe the responsibilities, procedures, and controls for laboratory operations?

• The master production record
• The laboratory standard operating procedures (SOPs)
• The marketing authorization dossier
• The facility maintenance contract

Correct Answer: The laboratory standard operating procedures (SOPs)

Q3. During inspection, a regulator asks for evidence of equipment qualification. Which sequence correctly represents the qualification lifecycle?

• OQ → IQ → PQ
• IQ → OQ → PQ
• PQ → OQ → IQ
• IQ → PQ only

Correct Answer: IQ → OQ → PQ

Q4. What is the most important element to verify when reviewing chromatographic system suitability records?

• Operator handwriting style
• System suitability acceptance criteria and documented compliance
• The brand of solvent bottles used
• Whether the run time was minimized

Correct Answer: System suitability acceptance criteria and documented compliance

Q5. Which principle is central to data integrity during a laboratory inspection?

• ALCOA+: data must be Attributable, Legible, Contemporaneous, Original, Accurate (and complete, consistent, enduring, available)
• Only digital data are acceptable
• All raw data must be destroyed after analysis
• Data can be modified without trace if supervisor approves

Correct Answer: ALCOA+: data must be Attributable, Legible, Contemporaneous, Original, Accurate (and complete, consistent, enduring, available)

Q6. A laboratory inspector finds outdated reference standard certificates. What is the best immediate corrective action?

• Continue using standards until they run out
• Quarantine affected standards and initiate investigation and replacement with certified standards
• Modify test results to match expectations
• Ignore the issue if past results look acceptable

Correct Answer: Quarantine affected standards and initiate investigation and replacement with certified standards

Q7. Which practice demonstrates appropriate chain-of-custody for samples under inspection?

• Leaving samples unlabeled on a bench
• Using a documented log showing sample receipt, storage conditions, transfers and analysts involved
• Recording only the final result without sample history
• Storing all stability samples together without identification

Correct Answer: Using a documented log showing sample receipt, storage conditions, transfers and analysts involved

Q8. In the context of laboratory inspections, what defines an Out-of-Specification (OOS) result?

• Any result that is better than the specification limit
• A result that does not conform to predefined specifications or acceptance criteria
• Any result obtained after working hours
• A result without chromatogram printout

Correct Answer: A result that does not conform to predefined specifications or acceptance criteria

Q9. Which element is essential in an effective OOS investigation seen during inspection?

• Immediate re-release of affected batch
• A documented root cause analysis, retest plan, and verification of corrective actions
• Destruction of all related raw data
• Blaming the analyst without investigation

Correct Answer: A documented root cause analysis, retest plan, and verification of corrective actions

Q10. What should an inspector expect to find regarding stability sample retention?

• No retention samples once product is released
• Defined retention sample policy with location, size, and retention period documented and followed
• Retention samples held without labeling indefinitely
• Samples returned to production for reuse

Correct Answer: Defined retention sample policy with location, size, and retention period documented and followed

Q11. Which aspect is critical when inspecting computerized laboratory systems (e.g., LIMS, chromatography data systems)?

• Presence of internet connectivity only
• Validation status, access controls, audit trails, and compliance with 21 CFR Part 11 principles
• Use of the latest operating system irrespective of validation
• Removal of all electronic logs to save storage

Correct Answer: Validation status, access controls, audit trails, and compliance with 21 CFR Part 11 principles

Q12. During an inspection, what indicates proper calibration practice for balances and pipettes?

• Calibrations performed irregularly without records
• Up-to-date calibration certificates, scheduled intervals, and documented acceptance criteria
• Calibration performed only when instruments fail
• Using visual checks instead of documented calibration

Correct Answer: Up-to-date calibration certificates, scheduled intervals, and documented acceptance criteria

Q13. Which factor is most relevant when assessing reagent and reference material control during inspection?

• Reagent bottles share the same label for all chemicals
• Traceability to supplier certificates, expiry monitoring and proper storage conditions
• Using highest concentration reagents for all tests
• Reagent lot numbers are not recorded

Correct Answer: Traceability to supplier certificates, expiry monitoring and proper storage conditions

Q14. How should deviations discovered during routine lab operations be managed to pass inspection?

• Documented, investigated for root cause, risk-assessed, and subject to CAPA with verification
• Ignored if they do not affect the final product
• Corrected verbally without records
• Logged only if a customer complains

Correct Answer: Documented, investigated for root cause, risk-assessed, and subject to CAPA with verification

Q15. What is an inspector likely to review to confirm analyst competency?

• Only the analyst’s resume without training records
• Training records, proficiency testing results, qualifications, and documented supervision
• Number of years employed irrespective of training
• Attendance records only

Correct Answer: Training records, proficiency testing results, qualifications, and documented supervision

Q16. Which control is important for preventing mix-ups in sample identification during inspection?

• Handwritten, ambiguous labels
• Unique sample identifiers, barcoding, and cross-check procedures
• Labeling with batch code only on request
• Storing multiple samples in the same container

Correct Answer: Unique sample identifiers, barcoding, and cross-check procedures

Q17. What should a robust analytical method transfer package contain for inspection review?

• Only the final report without supporting data
• Method protocol, validation data, acceptance criteria, and site-specific verification results
• Verbal confirmation of transfer
• Justified method deviations without verification

Correct Answer: Method protocol, validation data, acceptance criteria, and site-specific verification results

Q18. Which environmental control is typically evaluated during a laboratory inspection?

• Only the color of laboratory walls
• Temperature, humidity monitoring, cleanliness, and appropriate storage segmentation
• Noise levels in the cafeteria
• Number of windows in the lab

Correct Answer: Temperature, humidity monitoring, cleanliness, and appropriate storage segmentation

Q19. When an inspector reviews corrective and preventive action (CAPA) files, what demonstrates effectiveness?

• CAPA raised without implementation plan
• Defined actions, implementation timelines, impact assessment, and follow-up verification showing reduced recurrence
• CAPA closed immediately after opening
• CAPA actions recorded verbally only

Correct Answer: Defined actions, implementation timelines, impact assessment, and follow-up verification showing reduced recurrence

Q20. What is a critical inspection expectation for documentation of analytical results?

• Results summarized without raw data
• Complete documentation of raw data, calculations, instrument printouts, and reviewer approvals
• Only the electronic summary is acceptable without signatures
• Erase drafts after finalization to save space

Correct Answer: Complete documentation of raw data, calculations, instrument printouts, and reviewer approvals

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