WHO GDP and USP GDP MCQs With Answer

Introduction:

WHO GDP and USP GDP MCQs With Answer is designed to help M.Pharm students deepen their understanding of Good Distribution Practices (GDP) as defined by the World Health Organization and guidance from the United States Pharmacopeia. This quiz-focused resource emphasizes practical regulatory expectations for storage, transportation, documentation, traceability, temperature-controlled logistics, and supply-chain integrity. Each question reflects real-world scenarios pharmacists and regulatory professionals face when ensuring pharmaceutical quality from manufacturer to patient. Use these MCQs to test knowledge, prepare for exams, and reinforce competencies in GDP responsibilities, risk management, and compliance auditing required for effective pharmaceutical distribution oversight.

Q1. Which of the following best describes the primary objective of WHO Good Distribution Practices (GDP)?

• To regulate manufacturing processes of active pharmaceutical ingredients
• To ensure that products are consistently stored, transported and handled under suitable conditions to maintain quality and integrity
• To set maximum retail prices for medicines
• To provide marketing guidelines for pharmaceutical companies

Correct Answer: To ensure that products are consistently stored, transported and handled under suitable conditions to maintain quality and integrity

Q2. According to GDP principles, which activity is the responsibility of the Quality Unit in a distributor organisation?

• Designing promotional materials
• Performing final release testing of incoming products when necessary and approving release to market
• Managing sales targets and distributor discounts
• Handling customer complaints without documentation

Correct Answer: Performing final release testing of incoming products when necessary and approving release to market

Q3. Which of the following is a key difference between GMP and GDP?

• GMP focuses on distribution logistics while GDP focuses on manufacturing processes
• GDP covers the supply chain after product release, whereas GMP focuses on manufacture and quality control before release
• GMP applies only to generic medicines and GDP only to biologics
• There is no difference; both terms are interchangeable

Correct Answer: GDP covers the supply chain after product release, whereas GMP focuses on manufacture and quality control before release

Q4. Which measure is essential for maintaining vaccine cold chain integrity during transport according to WHO GDP?

• Using insulated containers without temperature monitoring
• Transporting in ambient vehicles only at night
• Validated shipping containers with calibrated temperature monitors or data loggers
• Labeling vaccines as non-temperature-sensitive

Correct Answer: Validated shipping containers with calibrated temperature monitors or data loggers

Q5. Under WHO GDP, what should be done with suspicious or damaged consignments on receipt?

• Immediately put them on sale at a discount
• Accept them and redeliver without documentation
• Quarantine, document findings, notify supplier, and initiate investigation
• Destroy them without record

Correct Answer: Quarantine, document findings, notify supplier, and initiate investigation

Q6. Which element is emphasized by USP guidance on distribution to strengthen supply-chain integrity?

• Mandatory use of a particular courier company
• Serialization and traceability systems to verify authenticity and movement of product
• Complete elimination of paper records
• Allowing repackaging without quality oversight

Correct Answer: Serialization and traceability systems to verify authenticity and movement of product

Q7. Which documentation is fundamental to demonstrate compliance with GDP during transportation?

• Temperature excursion records, transport validation reports, and chain-of-custody documentation
• Advertising brochures and social media posts
• Employee private emails
• Verbal confirmations without written records

Correct Answer: Temperature excursion records, transport validation reports, and chain-of-custody documentation

Q8. What is the recommended action when a temperature excursion is detected for a refrigerated medicine during transit?

• Automatically discard the product without assessment
• Assess the excursion using documented procedures, quarantine product, and perform risk-based evaluation before release or rejection
• Ignore it if the package looks intact
• Return to sender without investigation

Correct Answer: Assess the excursion using documented procedures, quarantine product, and perform risk-based evaluation before release or rejection

Q9. In USP GDP guidance, which practice helps prevent distribution of counterfeit or diverted medicines?

• Use of tamper-evident packaging, pedigree records, and supplier qualification
• Reducing batch testing frequency
• Allowing third-party repackagers to operate without oversight
• Storing medicines together with consumer goods

Correct Answer: Use of tamper-evident packaging, pedigree records, and supplier qualification

Q10. What is the role of risk management within a GDP-compliant distribution system?

• To eliminate all possible risks by stopping distribution
• To identify, assess, and control supply chain risks proportionately to protect product quality
• To transfer responsibility entirely to transport contractors
• To focus only on financial risks and ignore product integrity

Correct Answer: To identify, assess, and control supply chain risks proportionately to protect product quality

Q11. For wholesalers, which practice is mandated by WHO GDP regarding returned products?

• Immediately restocking returns without inspection
• Segregating returns, documenting reasons, and performing quarantine and evaluation before decisions on resale
• Automatically selling returns overseas
• Mixing returns with new stock to save space

Correct Answer: Segregating returns, documenting reasons, and performing quarantine and evaluation before decisions on resale

Q12. Which calibration practice is consistent with GDP requirements?

• Calibrating temperature monitors only when they fail
• Using uncalibrated instruments with visual checks
• Regularly calibrating and maintaining monitoring and transport instruments against traceable standards
• Delegating calibration records to drivers

Correct Answer: Regularly calibrating and maintaining monitoring and transport instruments against traceable standards

Q13. Which element should a GDP audit of a logistics provider evaluate according to USP and WHO principles?

• Quality of their advertising campaigns
• Competence of personnel, temperature control systems, security measures, and documentation practices
• Their ability to reduce prices each quarter
• Their social media following

Correct Answer: Competence of personnel, temperature control systems, security measures, and documentation practices

Q14. Under GDP, what is the significance of a written quality agreement between manufacturer and distributor?

• It is optional and used for marketing only
• It defines responsibilities for storage, transport, complaints, recalls and quality investigation ensuring clarity of roles
• It only covers payment terms
• It replaces the need for batch records

Correct Answer: It defines responsibilities for storage, transport, complaints, recalls and quality investigation ensuring clarity of roles

Q15. What is a required control for repackaging or relabelling performed by a distributor under GDP?

• No documentation is required if done quickly
• Repackaging must be covered by validated procedures, traceability, and quality oversight to prevent mix-ups and maintain expiry data
• Labels can be handwritten without authorization
• Expiry dates may be extended arbitrarily after repackaging

Correct Answer: Repackaging must be covered by validated procedures, traceability, and quality oversight to prevent mix-ups and maintain expiry data

Q16. According to GDP principles, how should complaints related to distributed product quality be handled?

• Logged, investigated promptly, and corrective and preventive actions implemented with records retained
• Ignored if complaints are under a set threshold
• Forwarded to marketing for response without investigation
• Only responded to verbally

Correct Answer: Logged, investigated promptly, and corrective and preventive actions implemented with records retained

Q17. Which practice is recommended for storage area design under GDP?

• Storage areas should allow cross-contamination between different product classes
• Storage must provide suitable environmental controls, segregation for quarantined and rejected items, and adequate access control
• Storing products on the floor for easier handling
• Allowing public access to warehouses for transparency

Correct Answer: Storage must provide suitable environmental controls, segregation for quarantined and rejected items, and adequate access control

Q18. Which is a key requirement for transport qualification under WHO GDP?

• Transport qualification is unnecessary for domestic shipments
• Demonstration by challenge studies or validation that packaging and transport conditions maintain required temperatures and protect product integrity
• Only the vehicle driver needs training
• Using the same unvalidated box for all products regardless of temperature needs

Correct Answer: Demonstration by challenge studies or validation that packaging and transport conditions maintain required temperatures and protect product integrity

Q19. Which control helps ensure product traceability throughout the distribution network?

• Discarding batch records after one year
• Maintaining complete shipment records, batch numbers, recipient details and serialization where applicable
• Relying on verbal confirmation of delivery only
• Mixing batch numbers to simplify inventory

Correct Answer: Maintaining complete shipment records, batch numbers, recipient details and serialization where applicable

Q20. According to GDP guidance, what training should distribution personnel receive?

• Only generic customer service training
• Specific GDP training covering product handling, temperature control, documentation, security and how to respond to excursions and deviations
• Training only in sales techniques
• No training is necessary for experienced staff

Correct Answer: Specific GDP training covering product handling, temperature control, documentation, security and how to respond to excursions and deviations

Download