Legal GDP requirements worldwide MCQs With Answer

Legal GDP requirements worldwide MCQs With Answer

Introduction: This quiz collection focuses on the legal requirements of Good Distribution Practice (GDP) as applied to medicines and pharmaceutical products around the world. It is designed for M.Pharm students preparing for regulatory, quality assurance, and supply‑chain roles. Questions cover international guidance (WHO, PIC/S), regional laws (EU Falsified Medicines Directive, DSCSA in the USA), key GDP elements such as licensing, temperature control, documentation, serialization, returns, and risk management. Practicing these MCQs will help reinforce practical knowledge of regulatory expectations and legal obligations that ensure product integrity, patient safety, and compliant distribution operations worldwide.

Q1. Which international body publishes a widely referenced guideline specifically titled “Guidelines on Good Distribution Practices (GDP)” for pharmaceutical products?

• European Commission — Guidelines on Good Distribution Practice (GDP)
• World Health Organization — Guidelines on Good Distribution Practices (GDP)
• PIC/S — Guide to Good Distribution Practice for Pharmaceutical Products
• International Council for Harmonisation (ICH) — Q10 Pharmaceutical Quality System

Correct Answer: World Health Organization — Guidelines on Good Distribution Practices (GDP)

Q2. Which European legal instrument introduced mandatory safety features and a unique identifier on certain medicinal product packs to combat falsified medicines?

• EU Falsified Medicines Directive (2011/62/EU)
• EU GDP Guidelines (2013/C 343/01)
• European Medicines Agency Regulation on Cold Chain (2015/CPH/12)
• EU Clinical Trial Regulation (536/2014)

Correct Answer: EU Falsified Medicines Directive (2011/62/EU)

Q3. In the United States, which act established enhanced product tracing, verification, and serialization requirements across the pharmaceutical supply chain?

• Food Drug and Cosmetic Act (FDCA)
• Drug Supply Chain Security Act (DSCSA)
• Controlled Substances Act (CSA)
• Biologics Price Competition and Innovation Act (BPCIA)

Correct Answer: Drug Supply Chain Security Act (DSCSA)

Q4. Which organization issues a guide used by many inspectorates for harmonized GDP expectations among participating inspectorates worldwide?

• International Council for Harmonisation (ICH)
• PIC/S — Guide to Good Distribution Practice for Pharmaceutical Products
• FDA — Current Good Distribution Practice Guidance
• World Trade Organization — Pharmaceutical Trade Guidelines

Correct Answer: PIC/S — Guide to Good Distribution Practice for Pharmaceutical Products

Q5. Which of the following is a universal legal requirement for pharmaceutical wholesalers in many countries under GDP rules?

• Obtain and maintain a wholesale distribution authorization (license)
• Only source APIs directly from the manufacturer
• Perform final batch release for all products
• Conduct clinical trials for distribution validation

Correct Answer: Obtain and maintain a wholesale distribution authorization (license)

Q6. Which is a legally required practice under GDP for temperature-controlled pharmaceutical distribution?

• Use unmonitored passive packaging for all refrigerated products
• Maintain validated cold-chain systems with qualification, temperature monitoring, and documented controls
• Rely solely on carrier guarantees without internal monitoring
• Allow temperature excursions up to 24 hours before assessment

Correct Answer: Maintain validated cold-chain systems with qualification, temperature monitoring, and documented controls

Q7. Which of the following is commonly required documentation under GDP regulations?

• Standard Operating Procedures (SOPs)
• Training and competence records
• Temperature and transport records
• All of the above

Correct Answer: All of the above

Q8. Which measure is specifically used to prevent and detect falsified medicines by providing a unique code at the pack level?

• Batch number only
• Serialization with a unique identifier and tamper-evident closure
• Manufacturer’s internal tracking sheet
• Barcode without aggregation or verification

Correct Answer: Serialization with a unique identifier and tamper-evident closure

Q9. Under EU legislation, which entity retains ultimate legal responsibility for the quality and safety of a medicinal product placed on the market?

• Wholesale distributor
• Marketing Authorization Holder (MAH)
• Logistics service provider
• National competent authority

Correct Answer: Marketing Authorization Holder (MAH)

Q10. According to GDP principles, how should returned pharmaceutical products typically be handled?

• Immediately restocked if packaging looks intact
• Quarantined and subject to a documented risk assessment before any reuse or destruction
• Automatically destroyed without assessment
• Resold to other wholesalers to avoid losses

Correct Answer: Quarantined and subject to a documented risk assessment before any reuse or destruction

Q11. Which US regulation is most commonly referenced for compliance when using electronic records and electronic signatures in distribution operations?

• 21 CFR Part 210 — GMP for Finished Pharmaceuticals
• 21 CFR Part 11 — Electronic Records; Electronic Signatures
• 21 CFR Part 58 — Good Laboratory Practice
• 21 CFR Part 820 — Quality System Regulation

Correct Answer: 21 CFR Part 11 — Electronic Records; Electronic Signatures

Q12. Which validation is specifically expected by GDP for ensuring the integrity of cold-chain transport?

• Analytical method validation only
• Transport qualification including temperature mapping and performance qualification
• Cleaning validation for transport vehicles only
• None — transport does not require formal validation

Correct Answer: Transport qualification including temperature mapping and performance qualification

Q13. What major DSCSA requirement reached full implementation milestones aimed at enabling interoperable electronic tracing of prescription drugs?

• Mandatory barcodes on OTC items
• Interoperable exchange of transaction information, transaction history, and transaction statements at the unit level
• Complete ban on re‑packagers
• Removal of serialization requirements for biologics

Correct Answer: Interoperable exchange of transaction information, transaction history, and transaction statements at the unit level

Q14. Which authority typically conducts inspections for GDP compliance of wholesalers within EU Member States?

• European Medicines Agency (EMA) inspectors for all wholesalers
• National Competent Authority (NCA) of the member state where the wholesaler is established
• World Health Organization inspectors
• Local municipal health inspectors only

Correct Answer: National Competent Authority (NCA) of the member state where the wholesaler is established

Q15. Which approach is central to modern legal GDP expectations for planning distribution controls and supplier oversight?

• Zero documentation policy
• Risk-based approach to distribution, qualification of carriers, and supplier auditing
• Relying only on supplier certificates without audits
• Ad hoc decisions without documented assessments

Correct Answer: Risk-based approach to distribution, qualification of carriers, and supplier auditing

Q16. For controlled substances under GDP and narcotics regulations, which of the following is typically a legal requirement for distributors?

• Maintain secure storage, restricted access, and complete transaction records for all movements
• Store controlled substances together with all other products without segregation
• Allow any employee to access controlled items with manager approval only
• Destroy records after 30 days

Correct Answer: Maintain secure storage, restricted access, and complete transaction records for all movements

Q17. Within GDP, what temperature range is generally considered the standard “refrigerated” condition for many pharmaceutical products?

• –20 °C to –10 °C
• 2 °C to 8 °C
• 15 °C to 25 °C
• 30 °C to 40 °C

Correct Answer: 2 °C to 8 °C

Q18. Which certificate is commonly used to support export of a medicinal product by confirming its regulatory status and compliance in the country of origin?

• Certificate of Analysis (CoA) only
• Certificate of Pharmaceutical Product (CPP) (WHO model)
• GDP Compliance Sticker
• Local Sales Tax Certificate

Correct Answer: Certificate of Pharmaceutical Product (CPP) (WHO model)

Q19. What is the primary purpose of serialization aggregation in pharmaceutical distribution?

• To increase packing speed without tracking
• To link unit-level unique identifiers to higher level shipping cases to enable efficient track-and-trace, recalls, and verification
• To avoid regulatory inspections
• To anonymize products for parallel trade

Correct Answer: To link unit-level unique identifiers to higher level shipping cases to enable efficient track-and-trace, recalls, and verification

Q20. When a cold-chain temperature excursion occurs during transport, what is the compliant GDP action for the distributor?

• Ignore the excursion if delivery is on time
• Quarantine the shipment, perform a documented risk assessment and investigation, and decide on disposition with records
• Automatically return to sender without assessment
• Donate the product if packaging remains intact

Correct Answer: Quarantine the shipment, perform a documented risk assessment and investigation, and decide on disposition with records

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