Premises, equipment, delivery and returns under GDP MCQs With Answer

Introduction: Premises, equipment, delivery and returns under Good Distribution Practices (GDP) are critical components of pharmaceutical supply chain integrity. This set of MCQs for M.Pharm students examines design, maintenance and operational controls needed to ensure product quality during storage, handling and transport. Topics include facility layout, HVAC and cold chain management, equipment qualification and calibration, documentation, segregation of quarantine/returned goods, secure delivery practices, and procedures for handling temperature excursions and product recalls. These questions focus on regulatory expectations, risk assessment principles, and practical scenarios that prepare students for real-world GDP responsibilities in manufacturing, distribution and quality assurance roles.

Q1. Which facility design feature is most important to prevent cross-contamination between different pharmaceutical products in a distribution warehouse?

• Proximity of loading docks to storage areas
• Dedicated, clearly segregated storage zones with controlled access
• High rack storage to maximize space
• Open-plan layout for easy movement

Correct Answer: Dedicated, clearly segregated storage zones with controlled access

Q2. Under GDP, which equipment qualification ensures that a temperature-controlled truck consistently maintains required conditions during routine transport?

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

Correct Answer: Performance Qualification (PQ)

Q3. What is the primary purpose of quarantine areas in a distribution centre operating under GDP?

• To provide temporary storage for overstocked items
• To hold products pending release after quality checks and documentation review
• To serve as a staging area for outgoing shipments
• To store returned expired goods for destruction

Correct Answer: To hold products pending release after quality checks and documentation review

Q4. Which document is essential to demonstrate the chain of custody during pharmaceutical product delivery?

• Purchase order copy
• Temperature log book
• Delivery note signed by consignee with timestamps
• Vehicle registration certificate

Correct Answer: Delivery note signed by consignee with timestamps

Q5. Which action is most appropriate when a temperature excursion is detected during transport of refrigerated drugs?

• Continue delivery and leave disposition to the consignee
• Immediately reject the shipment at recipient’s dock
• Quarantine the shipment and initiate documented investigation and risk assessment
• Adjust vehicle thermostat and proceed

Correct Answer: Quarantine the shipment and initiate documented investigation and risk assessment

Q6. Which of the following is a GDP requirement for vehicle hygiene and security?

• Vehicles must be painted a neutral colour
• Vehicles must be cleaned and, where necessary, disinfected before loading pharmaceutical products
• Drivers must use personal vehicles for convenience
• No specific requirements beyond regular maintenance

Correct Answer: Vehicles must be cleaned and, where necessary, disinfected before loading pharmaceutical products

Q7. What is the key consideration when handling returned pharmaceutical products under GDP?

• Automatically restock returned items if packaging looks intact
• Assess returned products through quarantine, documentation review and quality evaluation before any decision
• Destroy all returned products immediately
• Re-label returned products with a return sticker and reship

Correct Answer: Assess returned products through quarantine, documentation review and quality evaluation before any decision

Q8. Which calibration practice is most appropriate for temperature monitoring devices used in cold-chain storage?

• Calibration only when the device fails
• Periodic calibration traceable to national/international standards with documented records
• Calibration by the device operator using internal settings
• No calibration necessary if the device shows readings

Correct Answer: Periodic calibration traceable to national/international standards with documented records

Q9. Which control is most important to prevent mix-ups during loading and unloading at a distribution facility?

• Random selection of pallets for loading
• Use of a documented picking/packing checklist and verification by a second person
• Speeding up the process to reduce time on dock
• Allowing drivers to load their own vehicles

Correct Answer: Use of a documented picking/packing checklist and verification by a second person

Q10. In GDP, what is the purpose of route qualification for transport of temperature-sensitive medicines?

• To find the shortest route irrespective of conditions
• To ensure that the selected routes consistently meet time and temperature requirements and allow contingency planning
• To standardize fuel consumption across fleets
• To enable marketing teams to map distribution territories

Correct Answer: To ensure that the selected routes consistently meet time and temperature requirements and allow contingency planning

Q11. Which of the following documents should accompany returned products to support a decision on disposition?

• Only the customer’s verbal reason for return
• Complete return form including product batch number, expiry, reason for return and supporting documentation
• Delivery driver’s delivery note only
• Sales invoice and payment receipt only

Correct Answer: Complete return form including product batch number, expiry, reason for return and supporting documentation

Q12. Which environmental control is critical in a warehouse storing both sterile and non-sterile pharmaceuticals?

• Common HVAC system without zoning
• Zoned HVAC with differential controls to maintain required temperature, humidity and air cleanliness where applicable
• Only natural ventilation
• Use of ceiling fans to circulate air

Correct Answer: Zoned HVAC with differential controls to maintain required temperature, humidity and air cleanliness where applicable

Q13. What is the correct GDP approach for handling damaged packaging discovered during receipt of a batch?

• Accept the goods if the inner products appear fine
• Quarantine the batch, document damage, and initiate inspection and possible rejection or return to supplier
• Discard immediately without documentation
• Mark the batch for expedited shipping

Correct Answer: Quarantine the batch, document damage, and initiate inspection and possible rejection or return to supplier

Q14. Which monitoring system feature is most valuable for real-time control of cold-chain distribution?

• Local display only on the device
• Remote continuous monitoring with alarm notification and data logging
• Manual temperature checks once per day
• Printed stickers placed on each pallet

Correct Answer: Remote continuous monitoring with alarm notification and data logging

Q15. When returning a recalled product under GDP, what is the recommended initial action for the distributor?

• Resell the product at a discount
• Isolate and quarantine all affected stock, stop distribution and notify relevant authorities as per procedure
• Ignore the recall until stock is exhausted
• Mix recalled product with other stock to dilute effect

Correct Answer: Isolate and quarantine all affected stock, stop distribution and notify relevant authorities as per procedure

Q16. Which preventive maintenance practice helps ensure reliability of refrigerated storage equipment?

• Servicing only when equipment breaks down
• Scheduled preventive maintenance with records, including checks of alarms, defrost cycles and seals
• Relying on ambient facility temperature to compensate
• Turning equipment off during weekends to save energy

Correct Answer: Scheduled preventive maintenance with records, including checks of alarms, defrost cycles and seals

Q17. Which principle should guide segregation of returned goods that may be subject to reuse after evaluation?

• Store returns with saleable stock to avoid extra handling
• Place returns in a clearly marked, secure quarantine area pending evaluation and documented disposition
• Immediately repackage and place on shelf
• Allow sales staff to decide on reuse

Correct Answer: Place returns in a clearly marked, secure quarantine area pending evaluation and documented disposition

Q18. What is the role of SOPs (Standard Operating Procedures) related to delivery and returns under GDP?

• They are optional and used only during audits
• They define consistent processes for handling, documentation, traceability, discrepancies and corrective actions to ensure compliance
• They are used only for employee training and not for operations
• They are marketing documents to inform customers

Correct Answer: They define consistent processes for handling, documentation, traceability, discrepancies and corrective actions to ensure compliance

Q19. Which factor is most critical when selecting an external transport provider for GDP-regulated products?

• Lowest cost per kilometre
• Demonstrated competence in temperature-controlled transport, written procedures, training, and traceable records
• Proximity to your head office
• Availability of advertising space on vehicles

Correct Answer: Demonstrated competence in temperature-controlled transport, written procedures, training, and traceable records

Q20. Which record is essential to retain for investigating a suspected mix-up between two batches during distribution?

• Employee payroll records
• Complete batch traceability records including picking lists, loading manifests, delivery notes and reconciliation logs
• Marketing brochures
• Supplier marketing contacts

Correct Answer: Complete batch traceability records including picking lists, loading manifests, delivery notes and reconciliation logs

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