IPQC and line clearance MCQs With Answer

Introduction: IPQC and Line Clearance MCQs With Answer is designed to strengthen M.Pharm students’ understanding of in-process quality control (IPQC) and line clearance practices within pharmaceutical manufacturing. This concise blog provides concept-driven multiple-choice questions that emphasize regulatory expectations, practical procedures, documentation, and decision-making during production changeovers and in-process checks. Questions cover sampling, acceptance criteria, reconciliation, cleaning checks, segregation, and handling deviations—topics integral to cGMP compliance and batch integrity. Each MCQ includes four plausible options and a clear answer to help students prepare for exams and practical inspections, while promoting critical thinking for effective quality management on the shop floor.

Q1. What is the primary objective of in-process quality control (IPQC) during a pharmaceutical production run?

• To perform final product release testing after packaging
• To ensure process parameters are controlled and critical quality attributes are met during manufacturing
• To replace the need for finished product testing
• To record batch manufacturing details for archival only

Correct Answer: To ensure process parameters are controlled and critical quality attributes are met during manufacturing

Q2. Which activity best defines a line clearance procedure before starting a new batch on a production line?

• Running a test batch to verify machine speed
• Removing previous batch materials, cleaning equipment, and verifying documentation to prevent mix-ups
• Calibrating analytical instruments in the quality control laboratory
• Performing a final visual inspection of packaged products

Correct Answer: Removing previous batch materials, cleaning equipment, and verifying documentation to prevent mix-ups

Q3. Who is usually responsible for performing the actual line clearance and signing off prior to a new batch?

• Quality assurance only
• Production operator followed by independent verification by a supervisor or QA representative
• Warehouse manager
• Final packager

Correct Answer: Production operator followed by independent verification by a supervisor or QA representative

Q4. Which document must be checked and matched during line clearance to avoid using wrong materials?

• Calibration certificates
• Batch manufacturing record (BMR) or batch production record (BPR) and material labels
• Environmental monitoring logs from the previous day
• Employee training records

Correct Answer: Batch manufacturing record (BMR) or batch production record (BPR) and material labels

Q5. During IPQC, which parameter is typically monitored for a granulation process to ensure consistency?

• Ambient humidity only in the packaging area
• Granule size distribution, binder concentration, and moisture content
• Color of the final carton
• Reconciled paper documents

Correct Answer: Granule size distribution, binder concentration, and moisture content

Q6. What is the purpose of a hold point in the manufacturing process related to IPQC?

• To delay production indefinitely
• To require QA release before proceeding to the next critical step
• To store samples for stability testing only
• To clean the equipment after each shift

Correct Answer: To require QA release before proceeding to the next critical step

Q7. Which of the following is a critical element of a line clearance checklist?

• Verification of promotional materials
• Confirmation that all residues from the previous batch have been removed and equipment is clean
• Updating the company website
• Shipping schedule for finished goods

Correct Answer: Confirmation that all residues from the previous batch have been removed and equipment is clean

Q8. What should be done if an IPQC check indicates an out-of-specification (OOS) value during processing?

• Ignore it if only one value is OOS
• Quarantine affected material, investigate root cause, document findings and decide disposition with QA
• Continue processing and correct at final testing
• Discard the entire batch immediately without investigation

Correct Answer: Quarantine affected material, investigate root cause, document findings and decide disposition with QA

Q9. Which sampling plan is most appropriate for in-process checks when monitoring tablet weight during compression?

• Random sampling of a few tablets at defined intervals based on risk and statistical rationale
• Sampling only the first tablet produced
• Testing every tablet in the entire batch
• Sampling only after the batch is packaged

Correct Answer: Random sampling of a few tablets at defined intervals based on risk and statistical rationale

Q10. During line clearance, what is the significance of verifying label and packaging components?

• Labels are decorative and don’t affect quality
• To ensure correct labeling and prevent mislabeling, which could lead to product mix-ups or safety issues
• Packaging components can be verified after dispatch
• It is only necessary for marketing purposes

Correct Answer: To ensure correct labeling and prevent mislabeling, which could lead to product mix-ups or safety issues

Q11. Which of the following best describes reconciliation in the context of line clearance and IPQC?

• Balancing financial accounts for raw material purchases
• Accounting for quantities of materials used, yielded, and waste to ensure no unaccounted material remains
• Comparing employee attendance logs
• Confirming final product color consistency

Correct Answer: Accounting for quantities of materials used, yielded, and waste to ensure no unaccounted material remains

Q12. What action is essential immediately after a changeover when a product with high cross-contamination risk is followed by a different product?

• Skip cleaning if visual inspection is clean
• Perform validated cleaning procedures, swab for residuals, and verify results before starting the next batch
• Only change labels without cleaning equipment
• Proceed with production under supervision without tests

Correct Answer: Perform validated cleaning procedures, swab for residuals, and verify results before starting the next batch

Q13. Which regulatory expectation most directly drives the need for formal line clearance procedures?

• ISO 9001 requirements for marketing
• cGMP requirements to prevent contamination, mix-ups, and ensure traceability
• Financial auditing standards
• Occupational health rules unrelated to production

Correct Answer: cGMP requirements to prevent contamination, mix-ups, and ensure traceability

Q14. What documentation should be generated and retained after each line clearance event?

• Only verbal confirmation is required
• Completed line clearance checklist, signatures of responsible personnel, and any corrective actions taken
• Only a photograph of the cleaned line
• Sales order and delivery note

Correct Answer: Completed line clearance checklist, signatures of responsible personnel, and any corrective actions taken

Q15. Which is a critical in-process control for aseptic filling operations?

• Monitoring tablet weight
• Environmental monitoring of viable counts, differential pressure, and filter integrity checks
• Color matching of cartons
• Counting packing slips

Correct Answer: Environmental monitoring of viable counts, differential pressure, and filter integrity checks

Q16. In IPQC, trend analysis of in-process data is used primarily to:

• Increase production speed regardless of quality
• Identify drifts or shifts in process performance early and enable corrective actions
• Replace the need for any QC testing
• Only satisfy auditors without operational benefit

Correct Answer: Identify drifts or shifts in process performance early and enable corrective actions

Q17. What is the appropriate disposition for materials found remaining on line after a line clearance failure?

• Use them for the new batch if they look clean
• Quarantine and investigate; do not use until QA approves disposition
• Dispose of them immediately without documentation
• Ignore and proceed with production

Correct Answer: Quarantine and investigate; do not use until QA approves disposition

Q18. Which of the following is an important training topic for personnel performing line clearance and IPQC?

• Corporate social responsibility policies
• Procedure for line clearance, identification of critical control points, and documentation requirements
• How to design marketing brochures
• Stock market basics

Correct Answer: Procedure for line clearance, identification of critical control points, and documentation requirements

Q19. Which tool is commonly used to verify cleanliness during line clearance of equipment surfaces?

• pH paper for tablet coating
• Swab sampling followed by appropriate analytical testing for residues
• Counting labels manually
• Listening for unusual machine noises

Correct Answer: Swab sampling followed by appropriate analytical testing for residues

Q20. How does effective line clearance contribute to patient safety and product quality?

• By reducing paperwork only
• By preventing cross-contamination, ensuring correct labeling and batch integrity, thereby reducing risk to patients
• By increasing packaging speed at the cost of quality
• By eliminating the need for stability studies

Correct Answer: By preventing cross-contamination, ensuring correct labeling and batch integrity, thereby reducing risk to patients

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