Production management in pharma MCQs With Answer

Introduction

Production management in pharmaceuticals blends scientific rigor with robust operational control to ensure medicines are manufactured safely, efficiently, and compliantly. For M. Pharm students studying Modern Pharmaceutics (MPH 103T), mastering production planning and control, GMP systems, process validation, capacity utilization, and lean strategies is essential. This MCQ set focuses on core production concepts such as MPS/MRP, line clearance, change control, OEE, equipment qualification, HVAC, cleaning validation, and risk-based decision-making aligned with ICH guidelines. Each question is designed to test deeper understanding of practical shop-floor controls, documentation, and performance metrics that drive compliant, high-yield operations. Use these to assess your readiness for real-world production leadership in regulated pharmaceutical environments.

Q1. In a pharmaceutical plant, the Master Production Schedule (MPS) primarily serves to

• Translate sales and operations planning into a feasible, time-phased batch plan at SKU level
• Define equipment qualification protocols for critical process equipment
• Generate purchase orders directly to suppliers without BOM linkage
• Approve deviations arising during manufacturing

Correct Answer: Translate sales and operations planning into a feasible, time-phased batch plan at SKU level

Q2. The main objective of line clearance before starting a new batch is to

• Verify calibration and preventive maintenance of all shop-floor instruments
• Ensure complete removal of previous product/lot and materials to prevent mix-ups and cross-contamination
• Approve the Batch Manufacturing Record (BMR) for issuance
• Perform real-time release testing for the new batch

Correct Answer: Ensure complete removal of previous product/lot and materials to prevent mix-ups and cross-contamination

Q3. Overall Equipment Effectiveness (OEE) is calculated as

• Availability + Performance + Quality
• Availability × Performance × Quality
• (Availability × Performance) + Quality
• Performance × Quality ÷ Availability

Correct Answer: Availability × Performance × Quality

Q4. Which is the correct sequence of equipment qualification in pharmaceutical manufacturing?

• IQ → DQ → OQ → PQ
• DQ → IQ → OQ → PQ
• OQ → PQ → IQ → DQ
• PQ → OQ → IQ → DQ

Correct Answer: DQ → IQ → OQ → PQ

Q5. In the FDA’s 2011 process validation guidance, the three stages are

• Process Design, Performance Qualification, Continued Process Verification
• Process Qualification, Method Validation, Ongoing Verification
• Design Verification, Process Validation, Product Release
• Feasibility Study, Pilot Validation, Commercial Validation

Correct Answer: Process Design, Performance Qualification, Continued Process Verification

Q6. Material Requirements Planning (MRP) in a pharma context is used to

• Convert MPS into time-phased procurement and production orders using BOM and inventory status
• Schedule maintenance shutdowns for critical utilities
• Calculate OEE for filling lines
• Define sampling plans for IPC tests

Correct Answer: Convert MPS into time-phased procurement and production orders using BOM and inventory status

Q7. Yield reconciliation in the Batch Production Record (BPR) should account for

• Only the final finished goods yield versus theoretical
• All input materials and packaging components, intermediates, losses, rejects, and labels with documented variances
• In-process yields but not labeling components
• Utility consumption variance versus standard

Correct Answer: All input materials and packaging components, intermediates, losses, rejects, and labels with documented variances

Q8. A Kanban card on a packaging line is primarily used to

• Authorize batch release by QA
• Signal replenishment based on consumption to implement pull production and control WIP
• Record deviations during packaging
• Trigger preventive maintenance activities

Correct Answer: Signal replenishment based on consumption to implement pull production and control WIP

Q9. Which document captures unplanned departures from an approved process during manufacturing?

• Change control
• Deviation report
• Validation protocol
• Quality risk management plan

Correct Answer: Deviation report

Q10. In production scheduling, the Critical Ratio (CR) rule uses the formula

• (Processing time) ÷ (Remaining time until due date)
• (Due date − Current date) ÷ (Remaining processing time)
• (Setup time + Run time) ÷ (Batch size)
• (WIP) ÷ (Throughput)

Correct Answer: (Due date − Current date) ÷ (Remaining processing time)

Q11. Economic Order Quantity (EOQ) is a model that determines the order quantity that

• Maximizes supplier discounts irrespective of holding cost
• Minimizes total ordering and holding costs under steady demand and lead time
• Eliminates the need for safety stock in regulated environments
• Minimizes setup time for batch changeovers

Correct Answer: Minimizes total ordering and holding costs under steady demand and lead time

Q12. According to ICH Q9, Quality Risk Management in production primarily aims to

• Eliminate all risks through 100% inspection
• Systematically assess, control, communicate, and review risks to product quality
• Replace validation with real-time release testing
• Transfer risks from manufacturing to suppliers

Correct Answer: Systematically assess, control, communicate, and review risks to product quality

Q13. Pressure differentials in pharmaceutical HVAC systems are maintained mainly to

• Reduce energy consumption in cleanrooms
• Control airflows from high-cleanliness to lower-cleanliness areas to prevent contamination ingress
• Increase operator comfort during long shifts
• Ensure compliance with GDP documentation standards

Correct Answer: Control airflows from high-cleanliness to lower-cleanliness areas to prevent contamination ingress

Q14. A hold-time study for in-process bulk is performed to establish

• The minimum batch size based on equipment capacity
• The maximum allowable storage time and conditions without adverse impact on quality
• The stability of finished product in market packs
• The appropriate sampling plan for IPC tests

Correct Answer: The maximum allowable storage time and conditions without adverse impact on quality

Q15. Which of the following is NOT a commonly accepted approach for cleaning validation limits?

• Visually clean to specified criteria
• 10 ppm of previous product in next product
• 1/1000th of the minimum therapeutic dose carryover
• 5% of the maximum daily dose carryover

Correct Answer: 5% of the maximum daily dose carryover

Q16. Blend uniformity testing in solid dosage production is primarily intended to

• Confirm assay of finished dosage units meets label claim
• Demonstrate uniform API distribution within the blend before compression or encapsulation
• Assess lubricants’ impact on disintegration time
• Qualify the metal detector performance

Correct Answer: Demonstrate uniform API distribution within the blend before compression or encapsulation

Q17. A key benefit of implementing Electronic Batch Records (EBR) with MES is

• Elimination of QA oversight in batch release
• Real-time enforcement of process checks and improved data integrity (ALCOA+)
• Removal of the need for process validation
• Reduction of environmental monitoring frequency

Correct Answer: Real-time enforcement of process checks and improved data integrity (ALCOA+)

Q18. Which statement best differentiates reprocessing from rework in pharma production?

• Reprocessing repeats one or more steps as per the approved process; rework uses alternative processing outside the approved sequence
• Reprocessing is always prohibited; rework is always permitted
• Reprocessing changes the formulation; rework changes the batch size
• Reprocessing applies only to packaging; rework applies only to manufacturing

Correct Answer: Reprocessing repeats one or more steps as per the approved process; rework uses alternative processing outside the approved sequence

Q19. In Theory of Constraints (TOC) applied to pharma manufacturing, an appropriate action to improve throughput is to

• Maximize non-bottleneck utilization regardless of WIP
• Exploit and elevate the bottleneck by reducing changeovers there and protecting it with buffers (Drum-Buffer-Rope)
• Eliminate all quality checks to speed flow
• Increase batch sizes across all operations

Correct Answer: Exploit and elevate the bottleneck by reducing changeovers there and protecting it with buffers (Drum-Buffer-Rope)

Q20. Which activity should be initiated through change control prior to implementation?

• Temporary deviation to re-weigh a dispensed material
• Planned replacement of a mixer impeller design impacting shear profile
• Recording of an out-of-trend IPC result
• Label reconciliation at batch close-out

Correct Answer: Planned replacement of a mixer impeller design impacting shear profile

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