Production system inspection MCQs With Answer

Introduction: Production system inspection MCQs With Answer is a focused quiz set designed for M.Pharm students preparing for Quality Management Systems (MQA 102T). These questions emphasize inspection principles applied across pharmaceutical production—covering visual and automated inspections, sampling plans, in-process controls, equipment calibration, environmental monitoring, and acceptance criteria. The MCQs aim to deepen understanding of regulatory expectations (GMP, FDA, WHO), qualification stages, and risk-based inspection strategies. Each question is crafted to test conceptual clarity and practical decision-making skills required during production audits and batch release. Use this set for revision, self-assessment, and to strengthen competence in production system inspection and quality assurance practices.

Q1. Which document typically defines the acceptance criteria and inspection procedures for routine visual inspection of finished parenteral products?

• Quality Assurance Annual Report
• Batch Manufacturing Record
• Sampling and Inspection Plan / Inspection Procedure
• Maintenance Log

Correct Answer: Sampling and Inspection Plan / Inspection Procedure

Q2. During qualification of a new automated inspection machine, which stage verifies that the system performs consistently under simulated production conditions?

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Design Qualification (DQ)

Correct Answer: Performance Qualification (PQ)

Q3. Which acceptance sampling standard is most commonly referenced for lot-by-lot acceptance in pharmaceutical visual inspection?

• ISO 9001
• ANSI/ASQ Z1.4 (AQL sampling)
• ICH Q7
• ISO 14644

Correct Answer: ANSI/ASQ Z1.4 (AQL sampling)

Q4. In a risk-based inspection approach, which factor is most critical when prioritizing inspection focus for a production line?

• Operator seniority
• Product market price
• Patient safety and product quality impact
• Number of operators on the line

Correct Answer: Patient safety and product quality impact

Q5. What is the primary purpose of in-process inspection during production?

• To document operator attendance
• To identify potential nonconformities early and ensure control of critical parameters
• To reduce the number of final inspections
• To calibrate inspection equipment

Correct Answer: To identify potential nonconformities early and ensure control of critical parameters

Q6. Which parameter is most relevant when inspecting sterile manufacture areas as part of production system inspection?

• Relative humidity in warehouse
• Airborne particle counts and viable monitoring in classified cleanrooms
• Operator shoe size
• Number of manufacturing shifts per week

Correct Answer: Airborne particle counts and viable monitoring in classified cleanrooms

Q7. What is the main objective of container closure integrity (CCI) inspection for sterile products?

• To check label accuracy
• To ensure packaging aesthetics
• To verify the physical integrity of the container closure to prevent contamination
• To confirm expiration date printing

Correct Answer: To verify the physical integrity of the container closure to prevent contamination

Q8. Which corrective action is appropriate when an automated visual inspection system shows an increased false-reject rate?

• Lower acceptance criteria permanently
• Investigate cause, recalibrate/improve lighting or algorithms, and perform requalification if required
• Ignore and continue production
• Increase sample size without investigation

Correct Answer: Investigate cause, recalibrate/improve lighting or algorithms, and perform requalification if required

Q9. Which audit evidence is most effective to demonstrate that inspection procedures are followed on the production floor?

• Verbal confirmation from staff
• Signed inspection checklists, integrated camera logs, and batch records with timestamps
• Annual training certificates only
• Purchase orders for inspection equipment

Correct Answer: Signed inspection checklists, integrated camera logs, and batch records with timestamps

Q10. When inspecting a line for particulate contamination in parenteral products, which sampling approach is most appropriate?

• Random visual inspection of a single unit
• Statistically justified sample size based on AQL and criticality
• Inspect only the first and last unit of the batch
• Inspect units chosen by production supervisor preference

Correct Answer: Statistically justified sample size based on AQL and criticality

Q11. What is the role of calibration records during equipment inspection of measurement devices used in production?

• To show purchase date
• To provide evidence of traceability, calibration status, and measurement uncertainty for control decisions
• To record operator preferences
• To track supplier names only

Correct Answer: To provide evidence of traceability, calibration status, and measurement uncertainty for control decisions

Q12. Which inspection finding should trigger a formal deviation investigation and possible hold on batch release?

• Minor typo on a non-critical internal memo
• Critical defect in 2% of inspected dose units exceeding predefined acceptance criteria
• Operator late arrival by 5 minutes
• Temporary lighting flicker with no documented impact

Correct Answer: Critical defect in 2% of inspected dose units exceeding predefined acceptance criteria

Q13. For sterile fill-finish, which document typically outlines the environmental monitoring frequencies and alert/action limits relevant to inspection?

• Environmental Monitoring Program / SOP
• Employee Handbook
• Sales Forecast
• Supplier Qualification File

Correct Answer: Environmental Monitoring Program / SOP

Q14. Which statistical tool is most useful for monitoring trends in inspection defect counts over time?

• Pareto chart and control chart (SPC)
• Income statement
• Venn diagram
• Gantt chart

Correct Answer: Pareto chart and control chart (SPC)

Q15. When performing visual inspection of blister-packed tablets, what defect category is considered critical?

• Minor print smudge on outer carton
• Missing tablet in primary cavity exposed to environment
• Incorrect font size on inner leaflet
• Small cosmetic scratch on secondary packaging

Correct Answer: Missing tablet in primary cavity exposed to environment

Q16. Which element is essential in an inspection checklist to ensure regulatory compliance during production audits?

• Brand color preferences
• Reference to applicable GMP clauses, acceptance criteria, and responsible QA sign-offs
• Marketing slogans
• Employee birthdates

Correct Answer: Reference to applicable GMP clauses, acceptance criteria, and responsible QA sign-offs

Q17. In-process controls that are inspected during production of a tablet batch typically include which of the following?

• Media fill test
• Disintegration, weight variation, hardness, and moisture content checks
• Annual facility audit schedule
• Supplier price lists

Correct Answer: Disintegration, weight variation, hardness, and moisture content checks

Q18. Which of the following is an appropriate verification activity after corrective actions from an inspection finding are implemented?

• Assume issue resolved without evidence
• Effectiveness check: re-inspection, review of trending data, and follow-up audit
• Remove the finding from records
• Delay verification for one year

Correct Answer: Effectiveness check: re-inspection, review of trending data, and follow-up audit

Q19. For visual inspection of glass vials, what automated technology is commonly used to detect small cracks or foreign particles?

• Mass spectrometry
• Machine vision systems with backlighting and high-resolution cameras
• Ultrasound for label adhesion
• pH titration

Correct Answer: Machine vision systems with backlighting and high-resolution cameras

Q20. Which practice improves the reliability of inspection data collected during production audits?

• Using uncalibrated stopwatches for timing
• Standardized forms/checklists, trained inspectors, controlled sampling plans, and data integrity controls
• Allowing each inspector to use their own checklist format
• Recording results only verbally

Correct Answer: Standardized forms/checklists, trained inspectors, controlled sampling plans, and data integrity controls

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