Problems in non-sterile manufacturing MCQs With Answer

Introduction: This question bank focuses on common and critical problems encountered in non-sterile pharmaceutical manufacturing, tailored for M. Pharm students. It highlights operational, microbiological, quality assurance, and regulatory challenges that affect product quality, safety and compliance. The MCQs explore real-world issues such as cross-contamination, cleaning validation, process deviations, packaging failures, stability concerns, and environmental monitoring. Each question is designed to deepen understanding of root causes, preventive controls, and appropriate corrective actions under GMP. Use these items to test conceptual knowledge, prepare for viva/assessment, and sharpen problem-solving skills needed to manage and mitigate risks in non-sterile manufacturing environments.

Q1. What is the most likely root cause of cross-contamination between intermediate batches in a non-sterile solid dosage facility?

• Poorly trained QC analysts
• Inadequate equipment cleaning and segregation
• Incorrect raw material specification
• Expired stability samples

Correct Answer: Inadequate equipment cleaning and segregation

Q2. Which control is most effective to prevent airborne dust migration in a tablet compression room?

• Increased employee rotations
• High-efficiency local exhaust ventilation and proper airflows
• More frequent environmental monitoring
• Use of compressed air for cleaning

Correct Answer: High-efficiency local exhaust ventilation and proper airflows

Q3. During cleaning validation for non-sterile equipment, what is the primary acceptance criterion?

• Visual cleanliness only
• Absence of microbial growth on swabs
• Residue below established health-based or analytical limits
• Number of cleaning cycles performed

Correct Answer: Residue below established health-based or analytical limits

Q4. Which documentation best prevents label mix-ups during packaging of multiple products?

• Batch production record with in-line checks and label reconciliation
• Monthly inventory reports
• Operator verbal confirmation
• Manufacturer’s marketing brochures

Correct Answer: Batch production record with in-line checks and label reconciliation

Q5. A rise in microbial counts is observed in non-sterile oral liquid batches. What is the most appropriate initial investigation step?

• Discard all finished goods immediately
• Review recent water system and preservative efficacy test results
• Change the preservative system without investigation
• Increase sampling size for finished products only

Correct Answer: Review recent water system and preservative efficacy test results

Q6. Which factor most commonly leads to tablet capping and lamination during compression?

• Use of wrong colorant
• Inadequate granule consolidation or incorrect compression force
• Incorrect packaging orientation
• Excessive coating time

Correct Answer: Inadequate granule consolidation or incorrect compression force

Q7. For a potent API handled in a non-sterile facility, which risk control is essential to protect operators and prevent cross-contamination?

• Relocating QC lab to a different building
• Appropriate containment (closed transfer), local exhaust, and dedicated equipment
• Using shared bulk storage silos
• Reducing operator breaks

Correct Answer: Appropriate containment (closed transfer), local exhaust, and dedicated equipment

Q8. What is the best indicator that an in-process change is significant and requires formal change control?

• Minor cleaning procedure wording change
• Change that affects critical quality attributes, e.g., formulation composition or process parameters
• Reordering of stationery
• Operator preference for different gloves

Correct Answer: Change that affects critical quality attributes, e.g., formulation composition or process parameters

Q9. Which non-sterile packaging defect poses the highest patient safety risk?

• Wrong print color on box
• Incorrect dosage strength printed on label
• Minor tear in outer carton
• Slightly loose shrink wrap

Correct Answer: Incorrect dosage strength printed on label

Q10. What is a common cause of instability (assay loss) in non-sterile liquid formulations?

• Using amber bottles for light-sensitive drugs
• Inadequate antioxidant or preservative system and uncontrolled pH
• Excess headspace only
• Over-specified dissolution conditions

Correct Answer: Inadequate antioxidant or preservative system and uncontrolled pH

Q11. Which environmental monitoring practice is most critical for non-sterile manufacturing of topical creams?

• Air particulate monitoring only
• Surface and personnel monitoring combined with periodic air sampling in critical zones
• Weekly visual inspections only
• Monthly full cleanroom certification

Correct Answer: Surface and personnel monitoring combined with periodic air sampling in critical zones

Q12. In cleaning validation, the use of swab sampling is primarily to detect what?

• Remaining endotoxin levels
• Residual chemical/active substance on contact surfaces
• Bulk powder particle size distribution
• Electrical grounding compliance

Correct Answer: Residual chemical/active substance on contact surfaces

Q13. Which CAPA action is most appropriate when recurring packaging line jams cause product damage?

• Increase production speed to clear backlog
• Perform root cause analysis and implement engineering control changes and operator training
• Ignore minor product damage as acceptable
• Switch to a different supplier without analysis

Correct Answer: Perform root cause analysis and implement engineering control changes and operator training

Q14. What regulatory documentation supports justification for rework of non-sterile batches?

• Vendor marketing claim
• Approved rework protocol within the quality system and documented validation supporting the rework
• Operator’s verbal approval
• Uncontrolled email discussion

Correct Answer: Approved rework protocol within the quality system and documented validation supporting the rework

Q15. Which sampling scheme is most appropriate to detect blend uniformity issues in a large powder mixing operation?

• Single grab sample from one tote
• Multiple increment sampling across different depths and locations (composite or stratified)
• Only end-of-line finished product sampling
• Sampling the cleaning solution

Correct Answer: Multiple increment sampling across different depths and locations (composite or stratified)

Q16. Which preservative test is required to ensure microbiological stability of non-sterile aqueous formulations?

• Particle size analysis
• Preservative Efficacy Test (PET) / Challenge test
• Disintegration test
• Moisture sorption isotherm

Correct Answer: Preservative Efficacy Test (PET) / Challenge test

Q17. What is the primary concern when reworking partially compressed tablets by de-dusting and re-coating?

• Higher coating gloss
• Potential change in drug content uniformity and dissolution profile
• Improvement in tablet friability
• Reduction in manufacturing time

Correct Answer: Potential change in drug content uniformity and dissolution profile

Q18. Which preventive measure reduces the risk of waterborne contamination in non-sterile product manufacture?

• Use of potable water without monitoring
• Validated purified water system, routine microbiological monitoring and sanitary design
• Storing water in open drums
• Using steam directly without separation

Correct Answer: Validated purified water system, routine microbiological monitoring and sanitary design

Q19. A finished product shows unexpected odor and color change during stability. What is the best immediate action?

• Continue distribution as scheduled
• Quarantine affected lots and initiate stability failure investigation including chemical degradation analysis
• Change label to hide color variation
• Increase storage temperature for remainder of batches

Correct Answer: Quarantine affected lots and initiate stability failure investigation including chemical degradation analysis

Q20. Which analytical validation parameter is most critical when testing non-sterile drug content to detect low-level cross-contamination?

• Robustness only
• Limit of detection (LOD) and limit of quantitation (LOQ) with specificity
• Retention time only
• Vendor supplied method acceptance without verification

Correct Answer: Limit of detection (LOD) and limit of quantitation (LOQ) with specificity

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