Supply chain integrity standards MCQs With Answer

This blog offers a focused set of multiple-choice questions on Supply Chain Integrity Standards tailored for M.Pharm students preparing for exams in Good Regulatory Practices. The questions cover core topics such as Good Distribution Practice (GDP), serialization and traceability (GS1, EU FMD, US DSCSA), cold chain management, supplier qualification, anti‑counterfeiting measures, risk assessment (ICH Q9) and documentation/chain-of-custody requirements. Each MCQ is designed to test applied understanding of regulatory expectations, operational controls and risk‑based decision making across manufacturing, distribution and transportation. Use these questions for self-assessment, classroom discussion, and targeted revision to strengthen compliance knowledge essential for pharmaceutical supply chain management.

Q1. What is the primary international standard focused on ensuring quality in the storage and distribution of pharmaceutical products?

• Good Pharmacovigilance Practice (GVP)
• Good Manufacturing Practice (GMP)
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)

Correct Answer: Good Distribution Practice (GDP)

Q2. Which European regulatory instrument specifically requires unique identifier serialization on medicinal packs to prevent falsified medicines?

• EU Good Distribution Practice Guidelines
• Falsified Medicines Directive (FMD) – Delegated Regulation 2016/161
• Pharmacovigilance Risk Assessment Committee (PRAC) guidance
• ICH Q12 Guidance

Correct Answer: Falsified Medicines Directive (FMD) – Delegated Regulation 2016/161

Q3. The US Drug Supply Chain Security Act (DSCSA) primarily requires which of the following for prescription drug supply chains?

• Immediate ban on international suppliers
• Product tracing, verification and use of authorised trading partners
• Exclusive use of RFID for all products
• No requirement for serialization or traceability

Correct Answer: Product tracing, verification and use of authorised trading partners

Q4. What is the main purpose of GS1 standards in pharmaceutical supply chains?

• To set manufacturing batch sizes
• To provide unique identification (GTIN and serial numbers) and data exchange for traceability
• To establish clinical trial protocols
• To regulate pricing and reimbursement

Correct Answer: To provide unique identification (GTIN and serial numbers) and data exchange for traceability

Q5. In cold chain integrity, what constitutes a temperature excursion?

• Any opening of a refrigerated container during loading
• Deviation of product temperature outside the predefined acceptable limits
• Using a different courier than planned
• Delay of shipment without temperature monitoring

Correct Answer: Deviation of product temperature outside the predefined acceptable limits

Q6. Tamper‑evident packaging in pharmaceutical distribution is primarily intended to:

• Improve aesthetic appeal of the product
• Indicate whether a pack has been opened or altered after release
• Extend the product shelf life
• Reduce production costs

Correct Answer: Indicate whether a pack has been opened or altered after release

Q7. Which activity is essential during supplier qualification to maintain supply chain integrity?

• Conducting on-site audits and establishing quality agreements
• Only relying on supplier brochures
• Accepting verbal assurances without documentation
• Choosing suppliers solely on lowest cost

Correct Answer: Conducting on-site audits and establishing quality agreements

Q8. Chain of custody documentation for pharmaceutical shipments should typically include which of the following?

• Only the invoice amount
• Bill of lading, transfer records and custody handover signatures
• Marketing brochures and promotional material
• Pharmacovigilance case reports

Correct Answer: Bill of lading, transfer records and custody handover signatures

Q9. Which anti‑counterfeiting technology combination is commonly implemented to improve product authentication at point of dispensing?

• Serialization with unique identifiers and 2D/QR codes for verification
• Changing the pill colour every batch
• Using larger boxes to hide contents
• Removing batch numbers from labels

Correct Answer: Serialization with unique identifiers and 2D/QR codes for verification

Q10. According to ICH Q9 principles, risk assessment in supply chain management is used to:

• Replace all quality controls with inspections
• Identify, evaluate and control risks to product quality and supply chain integrity
• Justify not monitoring temperature during transport
• Automate regulatory inspections

Correct Answer: Identify, evaluate and control risks to product quality and supply chain integrity

Q11. Which validation activity is required to demonstrate the suitability of refrigerated transport for a vaccine shipment?

• Temperature mapping and transport validation studies
• Only visual inspection of the container
• Counting the number of packages shipped
• Ensuring the courier has an icebox in the vehicle

Correct Answer: Temperature mapping and transport validation studies

Q12. Which organization provides widely referenced Good Distribution Practice (GDP) guidance for global use, especially in low- and middle-income countries?

• World Health Organization (WHO)
• International Conference on Harmonisation (ICH)
• European Centre for Disease Prevention and Control (ECDC)
• World Trade Organization (WTO)

Correct Answer: World Health Organization (WHO)

Q13. A best practice for securing pharmaceutical shipments during transport includes which measure?

• Tamper‑evident seals combined with GPS tracking and route security
• Leaving packages visible in unlocked vehicles overnight
• Using unlabelled personal vehicles for large consignments
• Mixing pharmaceuticals with unrelated cargo to disguise contents

Correct Answer: Tamper‑evident seals combined with GPS tracking and route security

Q14. When suspected counterfeit or diverted medicines are discovered in a warehouse, the immediate regulatory‑aligned action should be to:

• Sell them quickly to recover costs
• Quarantine the products and notify the competent regulatory authority
• Destroy all other stock without investigation
• Mix them with legitimate stock to dilute risk

Correct Answer: Quarantine the products and notify the competent regulatory authority

Q15. A quality agreement between a manufacturer and a distributor should primarily define which of the following?

• Responsibilities for storage, shipping, complaint handling, recalls and change control
• The colour scheme for marketing materials
• Employee dress code at the distributor
• Pricing strategy for the product

Correct Answer: Responsibilities for storage, shipping, complaint handling, recalls and change control

Q16. The GS1 data model for identifying an individual pharmaceutical pack normally combines which elements?

• Carrier name and vehicle registration
• GTIN plus a unique serial number
• Expiry date only
• Manufacturer logo and batch code only

Correct Answer: GTIN plus a unique serial number

Q17. Under DSCSA, an Authorized Trading Partner (ATP) requirement is intended to ensure what?

• That only large companies can trade prescription drugs
• Trustworthy entities handle product transactions to enhance supply chain security
• All products must be exported within 24 hours
• Manufacturers no longer need to keep records

Correct Answer: Trustworthy entities handle product transactions to enhance supply chain security

Q18. Effective management of returned pharmaceutical products should include which control?

• Immediate reintegration into stock without checks
• Verification, quarantine and documented disposition decision
• Automatic resale on a discount platform
• Discarding all returned products without recording

Correct Answer: Verification, quarantine and documented disposition decision

Q19. Which is a key benefit of implementing an electronic track‑and‑trace system across the supply chain?

• Increased paperwork and manual reconciliation
• Real‑time visibility, faster recalls and improved verification of authenticity
• Reduced ability to detect diversion
• Longer lead times for distribution

Correct Answer: Real‑time visibility, faster recalls and improved verification of authenticity

Q20. How should audit frequency for distributors and transport partners be determined to maintain supply chain integrity?

• Based on a fixed annual schedule irrespective of risk
• Risk‑based, with regular intervals and triggered by significant changes or incidents
• Only when a regulatory inspector requests it
• Never, audits are unnecessary if contracts exist

Correct Answer: Risk‑based, with regular intervals and triggered by significant changes or incidents

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