Good Distribution Practices (GDP) MCQs With Answer

Good Distribution Practices (GDP) MCQs With Answer

Introduction: This blog provides a focused set of multiple-choice questions on Good Distribution Practices (GDP) tailored for M.Pharm students preparing for exams and professional practice. The questions cover core GDP principles—storage, transportation, documentation, cold chain management, traceability, returns handling, audits and regulatory expectations—presented with clear options and answers to reinforce learning. Each question is designed to deepen understanding of how GDP preserves pharmaceutical quality and patient safety throughout the distribution chain, highlighting practical and regulatory aspects you will encounter in industry and inspections. Use these MCQs to test knowledge, identify gaps, and consolidate best practices for compliant distribution systems.

Q1. What is the primary objective of Good Distribution Practices (GDP)?

• Ensure product cost-effectiveness in the supply chain
• Ensure correct advertising of pharmaceutical products
• Ensure that the quality and integrity of medicinal products are maintained throughout the distribution chain
• Ensure faster delivery times only

Correct Answer: Ensure that the quality and integrity of medicinal products are maintained throughout the distribution chain

Q2. Which of the following activities is directly covered by GDP?

• Manufacturing process validation
• Storage and transportation of finished medicinal products
• Clinical trial design
• Active pharmaceutical ingredient (API) synthesis

Correct Answer: Storage and transportation of finished medicinal products

Q3. Who is ultimately responsible for ensuring GDP compliance within a distribution organization?

• Only the warehouse manager
• Only the company’s CEO
• All persons involved in the distribution process following designated responsibilities and SOPs
• The transport driver alone

Correct Answer: All persons involved in the distribution process following designated responsibilities and SOPs

Q4. For temperature-sensitive medicinal products, what is a key GDP requirement during transport?

• Use of any available vehicle without monitoring
• Continuous temperature-controlled transport with validated packaging and temperature monitoring devices
• Only visual inspection on receipt at destination
• Transport only at night to reduce exposure

Correct Answer: Continuous temperature-controlled transport with validated packaging and temperature monitoring devices

Q5. What type of record is essential for product traceability in GDP?

• Employee payroll records
• Batch-level records linking supplier, batch number, shipping and receiving data
• Marketing campaign logs
• Customer satisfaction surveys

Correct Answer: Batch-level records linking supplier, batch number, shipping and receiving data

Q6. Which stock rotation principle is recommended under GDP for expiry control?

• Last In First Out (LIFO)
• First Expired First Out (FEFO)
• Random selection
• First In Last Out (FILO)

Correct Answer: First Expired First Out (FEFO)

Q7. What action should be taken when receiving a shipment that shows visible damage or signs of temperature excursion?

• Put into general stock and sell quickly
• Quarantine the shipment, document observations, and initiate investigation before release
• Return to sender without documentation
• Ignore and distribute if packaging still sealed

Correct Answer: Quarantine the shipment, document observations, and initiate investigation before release

Q8. What is meant by qualification of transport vehicles in GDP?

• Testing drivers’ knowledge only
• Assessment and validation that vehicles and transport systems consistently maintain required conditions (e.g., temperature) under defined operating ranges
• Painting vehicles with company logo
• Scheduling more frequent trips

Correct Answer: Assessment and validation that vehicles and transport systems consistently maintain required conditions (e.g., temperature) under defined operating ranges

Q9. According to common GDP guidance, how long should distribution records generally be retained?

• 1 week after dispatch
• At least one year after the expiry date of the batch or as required by local regulation
• Only until stock is depleted
• Records can be discarded immediately after delivery

Correct Answer: At least one year after the expiry date of the batch or as required by local regulation

Q10. Which of the following is a primary risk GDP aims to mitigate?

• Incorrect clinical trial results
• Product quality deterioration, diversion, and falsification during distribution
• Poor manufacturing yields
• Marketing non-compliance

Correct Answer: Product quality deterioration, diversion, and falsification during distribution

Q11. If a temperature excursion is detected during storage, what is the correct GDP response?

• Immediately dispose of all stock without assessment
• Quarantine affected stock, assess impact via investigation and laboratory testing if necessary, and decide on release or disposal
• Return stock to supplier without documentation
• Continue to distribute older stock first

Correct Answer: Quarantine affected stock, assess impact via investigation and laboratory testing if necessary, and decide on release or disposal

Q12. How often should internal GDP audits typically be performed?

• Never, audits are optional
• At least annually and after significant changes to systems or processes
• Only when there is a regulatory inspection imminent
• Only when a customer complains

Correct Answer: At least annually and after significant changes to systems or processes

Q13. Which information is critical on distribution labels under GDP?

• Storage conditions, batch number and expiry date
• Employee salary details
• Competitor pricing
• Customer purchasing history

Correct Answer: Storage conditions, batch number and expiry date

Q14. What documents should accompany temperature-sensitive shipments to demonstrate compliance?

• Only the invoice
• Temperature records, calibration certificates for monitoring devices, and shipping documentation
• Employee personal IDs
• Marketing brochures

Correct Answer: Temperature records, calibration certificates for monitoring devices, and shipping documentation

Q15. In GDP, what does “traceability” enable a distributor to do?

• Determine the cheapest shipping route
• Track the history, application or location of an item to enable recall and investigation
• Manipulate expiry dates
• Automate sales promotions

Correct Answer: Track the history, application or location of an item to enable recall and investigation

Q16. Why are Standard Operating Procedures (SOPs) important in GDP?

• They replace regulatory requirements
• They provide consistent, documented methods to perform distribution tasks in compliance with GDP
• They are only useful for marketing staff
• They eliminate the need for training

Correct Answer: They provide consistent, documented methods to perform distribution tasks in compliance with GDP

Q17. What is the purpose of a quarantine area in a GDP-compliant warehouse?

• To store fast-moving products for quick access
• To segregate suspect, returned or unreleased goods until they are released or disposed
• To display new products to customers
• To store employee personal belongings

Correct Answer: To segregate suspect, returned or unreleased goods until they are released or disposed

Q18. Which organization published authoritative global guidelines specifically for GDP of pharmaceutical products?

• World Health Organization (WHO)
• International Olympic Committee
• World Trade Organization
• United Nations Security Council

Correct Answer: World Health Organization (WHO)

Q19. How should returned medicines be handled under GDP?

• Immediately returned to general stock
• Assessed, quarantined, documented and released only after evaluation confirms they meet quality requirements
• Sold at discount without checks
• Discarded without documentation

Correct Answer: Assessed, quarantined, documented and released only after evaluation confirms they meet quality requirements

Q20. Which situation represents a critical deviation from GDP for cold chain products?

• Using validated insulated packaging and monitoring temperature
• Complete loss of temperature control for vaccines during transit without documentation or investigation
• Recording temperature readings as required
• Maintaining calibrated temperature loggers

Correct Answer: Complete loss of temperature control for vaccines during transit without documentation or investigation

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