Production planning and control MCQs With Answer

Production planning and control (PPC) is a cornerstone of pharmaceutical manufacturing that ensures medicines are produced on time, in the right quantity, and with required quality while meeting stringent regulatory demands. This quiz collection focuses on advanced PPC concepts relevant to M.Pharm students, integrating operational techniques (MRP, scheduling, capacity planning), quality and regulatory interfaces (batch release, validation, change control), and modern lean tools (JIT, Kanban, OEE). The questions emphasize practical decision-making, real-world constraints such as testing lead times and cleanroom scheduling, and metrics used to measure performance. Use these MCQs to sharpen both theoretical understanding and applied problem-solving skills in pharmaceutical production environments.

Q1. Which statement best describes the primary objective of production planning and control in pharmaceutical manufacturing?

• Maximize production output regardless of regulatory requirements
• Ensure timely availability of quality products while maintaining regulatory compliance and optimal resource utilization
• Minimize labor costs by automating all processes
• Maintain the largest possible inventory to avoid stockouts

Correct Answer: Ensure timely availability of quality products while maintaining regulatory compliance and optimal resource utilization

Q2. How does Material Requirements Planning (MRP) principally differ from an Enterprise Resource Planning (ERP) system in a pharmaceutical setting?

• MRP manages quality control, ERP manages only production
• MRP focuses on materials and component scheduling; ERP integrates MRP with finance, QA, HR and broader enterprise functions
• MRP is hardware, ERP is software
• MRP schedules personnel shifts, ERP handles lab testing

Correct Answer: MRP focuses on materials and component scheduling; ERP integrates MRP with finance, QA, HR and broader enterprise functions

Q3. In project-level scheduling for a campaign changeover of a sterile product, which technique uses deterministic task durations and identifies the longest path through the network?

• PERT (Program Evaluation and Review Technique)
• Critical Path Method (CPM)
• Kanban scheduling
• Time-driven Activity-Based Costing

Correct Answer: Critical Path Method (CPM)

Q4. In pharmaceutical PPC, which action must occur before a finished batch can be released for distribution?

• Automatic release after production completion
• Release by Quality Unit after satisfactory sampling and analytical testing
• Immediate packaging without documentation review
• Release only after shipment

Correct Answer: Release by Quality Unit after satisfactory sampling and analytical testing

Q5. Which of the following is NOT typically considered a component of total lead time in pharmaceutical production planning?

• Procurement lead time for active and excipients
• Manufacturing (processing) lead time
• Analytical testing and release lead time
• Historical market share data analysis

Correct Answer: Historical market share data analysis

Q6. For a product with stable demand in a pharmaceutical packing line, which lot-sizing method is most focused on minimizing the combined ordering and holding costs?

• Economic Order Quantity (EOQ)
• Lot-for-lot (L4L)
• Fixed period ordering
• Push scheduling

Correct Answer: Economic Order Quantity (EOQ)

Q7. Which statement best characterizes the applicability of Kanban and Just-In-Time (JIT) in pharmaceutical manufacturing?

• Kanban and JIT are universally applicable to sterile batch manufacture without modification
• They are most applicable to low-variability, short lead-time activities such as secondary packaging and component replenishment; their use in core sterile processing is limited due to long testing and release times
• These methods eliminate the need for quality control sampling
• They replace the need for master production scheduling

Correct Answer: They are most applicable to low-variability, short lead-time activities such as secondary packaging and component replenishment; their use in core sterile processing is limited due to long testing and release times

Q8. Overall Equipment Effectiveness (OEE) is the product of which three factors used to evaluate equipment performance?

• Availability, Performance, and Quality
• Throughput, Inventory, and Lead time
• Setup time, Downtime, and Labor efficiency
• Yield, Purity, and Potency

Correct Answer: Availability, Performance, and Quality

Q9. Which planning horizon is typically associated with aggregate planning of production in pharmaceuticals (balancing capacity and demand at a product family level)?

• Short-term operational (days to weeks)
• Medium-term aggregate (months; e.g., 3–18 months)
• Instantaneous real-time control
• Long-term strategic (10+ years)

Correct Answer: Medium-term aggregate (months; e.g., 3–18 months)

Q10. A typical MRP system for a capsule product will produce which of the following outputs critical for PPC?

• Planned order releases and purchase requisitions for components
• Final batch release certificates
• Regulatory inspection reports
• Finished product marketing strategy

Correct Answer: Planned order releases and purchase requisitions for components

Q11. Which document is central to production planning and defines what finished products will be built, in what quantity, and when?

• Master Production Schedule (MPS)
• Batch Manufacturing Record (BMR)
• Analytical Test Report
• Quality Manual

Correct Answer: Master Production Schedule (MPS)

Q12. In PPC terminology, how does routing differ from scheduling?

• Routing defines the sequence of operations and resources; scheduling assigns specific start and finish times for those operations
• Routing sets batch sizes; scheduling determines quality tests
• Routing is a finance activity; scheduling is a maintenance activity
• Routing is used only for distribution, scheduling only for production

Correct Answer: Routing defines the sequence of operations and resources; scheduling assigns specific start and finish times for those operations

Q13. Which type of process validation is performed before routine commercial production to demonstrate that a process consistently produces product meeting predetermined specifications?

• Concurrent validation
• Retrospective validation
• Prospective validation
• Cleaning validation only

Correct Answer: Prospective validation

Q14. What is the primary purpose of maintaining safety stock in pharmaceutical inventory planning?

• To increase carrying costs deliberately
• To provide a buffer against variability in demand and supply, including testing and release delays
• To eliminate the need for forecasting
• To ensure batch sizes are always maximized

Correct Answer: To provide a buffer against variability in demand and supply, including testing and release delays

Q15. Which planning tool provides a visual timeline of tasks and is commonly used on the shop floor to track campaign progress and changeovers?

• Gantt chart
• Pareto chart
• Control chart
• Affinity diagram

Correct Answer: Gantt chart

Q16. According to the Theory of Constraints applied to a pharmaceutical production line, improving overall throughput is best achieved by focusing resources on:

• Non-critical free-capacity machines
• Bottleneck operations that limit system throughput
• Only on packaging to speed final output
• Increasing workforce across all areas equally

Correct Answer: Bottleneck operations that limit system throughput

Q17. Where should received raw materials be stored before they are released for production in a GMP-compliant PPC system?

• Directly on the production floor with released stock
• In a designated quarantine area separated from released and rejected materials
• Mixed with finished goods in the warehouse
• Discarded immediately after receipt

Correct Answer: In a designated quarantine area separated from released and rejected materials

Q18. Why is formal change control critical within production planning and control for pharmaceuticals?

• It speeds up production by removing documentation requirements
• It ensures changes to processes, equipment, or materials are evaluated, authorized, and documented to maintain compliance and product quality
• It allows managers to make ad-hoc changes without informing QA
• It replaces the need for re-validation

Correct Answer: It ensures changes to processes, equipment, or materials are evaluated, authorized, and documented to maintain compliance and product quality

Q19. Which KPI most directly measures how well production adheres to scheduled completion dates for pharmaceutical batches?

• On-time completion rate (schedule adherence)
• Inventory turnover ratio
• Gross margin percentage
• Number of pending CAPAs

Correct Answer: On-time completion rate (schedule adherence)

Q20. What is the role of poka-yoke (error-proofing) techniques in pharmaceutical production planning and control?

• To eliminate the need for skilled operators
• To create deliberate process complexity
• To prevent human errors at the point of operation and thereby reduce deviations and rework
• To replace all laboratory testing

Correct Answer: To prevent human errors at the point of operation and thereby reduce deviations and rework

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