Vendor qualification MCQs With Answer

Introduction:

Vendor qualification MCQs With Answer is designed specifically for M. Pharm students preparing for exams in Quality Management Systems (MQA 102T). This quiz set focuses on vendor qualification principles, regulatory expectations, supplier assessment, auditing, documentation, and ongoing monitoring — topics central to ensuring a robust pharmaceutical supply chain. Each question reinforces key concepts such as prequalification, technical/quality agreements, sampling, COA interpretation, CAPA, change control, and supplier performance metrics. Practicing these targeted MCQs with answers helps students build practical understanding applicable to GMP-compliant vendor management, audit preparation, and regulatory inspections, while strengthening problem-solving skills required in pharmaceutical quality assurance.

Q1. What is the primary objective of vendor qualification in pharmaceutical quality systems?

• To establish commercial terms and negotiate pricing
• To ensure consistent quality and regulatory compliance of supplied materials and services
• To certify suppliers to ISO standards only
• To delegate final product release to the vendor

Correct Answer: To ensure consistent quality and regulatory compliance of supplied materials and services

Q2. Which sequence best describes the typical stages of vendor qualification?

• Approval → Audit → Prequalification → Monitoring
• Prequalification → On-site audit → Approval → Ongoing monitoring and requalification
• Monitoring → Approval → Audit → Prequalification
• Contract signing → Product release → Audit → Requalification

Correct Answer: Prequalification → On-site audit → Approval → Ongoing monitoring and requalification

Q3. Which document specifically defines responsibilities for quality, specifications, testing and change control between manufacturer and supplier?

• Purchase order
• Technical or Quality Agreement
• Certificate of Analysis
• Commercial invoice

Correct Answer: Technical or Quality Agreement

Q4. What is the primary purpose of a supplier self-assessment questionnaire during vendor qualification?

• To replace an on-site audit permanently
• To provide preliminary information on the supplier’s systems and identify risks before deciding on on-site audit
• To validate test methods used by the supplier
• To serve as the final approval document for high-risk suppliers

Correct Answer: To provide preliminary information on the supplier’s systems and identify risks before deciding on on-site audit

Q5. Which audit type is typically performed remotely by reviewing submitted documents and records rather than visiting the supplier site?

• On-site audit
• Process capability audit
• Desk or remote (documentary) audit
• Regulatory inspection

Correct Answer: Desk or remote (documentary) audit

Q6. How should a company classify a supplier that provides active pharmaceutical ingredients (APIs) critical to product safety and efficacy?

• Low-risk indirect supplier
• Critical supplier requiring stringent qualification and monitoring
• Supplier exempt from qualification if COA provided
• Only a commercial supplier with no GMP relevance

Correct Answer: Critical supplier requiring stringent qualification and monitoring

Q7. Which document issued by a supplier contains test results for a specific batch and is used during incoming release?

• Certificate of Analysis (COA)
• Certificate of Origin (COO)
• Quality agreement
• Bill of lading

Correct Answer: Certificate of Analysis (COA)

Q8. For suppliers classified as critical, what is a commonly recommended maximum interval for formal re-audit under GMP guidance?

• 10 years
• Annually
• Every 10 months only if issues arise
• No re-audit is necessary after initial approval

Correct Answer: Annually

Q9. Which formal system is used to record and track corrective and preventive actions following supplier audit findings?

• Purchase order tracking
• CAPA (Corrective and Preventive Action) system
• Invoice reconciliation
• Batch release log

Correct Answer: CAPA (Corrective and Preventive Action) system

Q10. If incoming raw material COA indicates an out-of-specification (OOS) result, the immediate correct action is to:

• Release the material and note the discrepancy
• Quarantine the material and initiate investigation with supplier involvement
• Return the material without further investigation
• Ignore COA and perform only visual inspection

Correct Answer: Quarantine the material and initiate investigation with supplier involvement

Q11. Which metric is commonly used to monitor supplier performance in a pharmaceutical supply chain?

• On-time-in-full (OTIF) delivery rate
• Supplier office decor
• Number of social media followers
• Supplier’s annual marketing spend

Correct Answer: On-time-in-full (OTIF) delivery rate

Q12. A supplier holds ISO 9001 certification. Which statement is true regarding GMP compliance?

• ISO 9001 certification automatically ensures full GMP compliance
• ISO 9001 proves quality but does not substitute for GMP-specific qualification or inspection
• ISO 9001 is irrelevant to pharmaceutical suppliers
• ISO 9001 certifies sterility of products

Correct Answer: ISO 9001 proves quality but does not substitute for GMP-specific qualification or inspection

Q13. Which element should always be included in a technical/quality agreement with a vendor?

• Detailed personal salaries of supplier staff
• Responsibilities for change control and prior notification of changes affecting quality
• Supplier marketing plans
• Retail prices for finished products

Correct Answer: Responsibilities for change control and prior notification of changes affecting quality

Q14. What information does a Drug Master File (DMF) provided by an API supplier typically contain that is useful for vendor qualification?

• Complete corporate financial statements
• Chemistry, Manufacturing and Controls (CMC) information and manufacturing details
• Retail distribution lists
• Patient level adverse event reports

Correct Answer: Chemistry, Manufacturing and Controls (CMC) information and manufacturing details

Q15. Which department in a pharmaceutical company holds primary responsibility for approving and maintaining vendor qualification records?

• Sales and marketing
• Quality Assurance (QA)
• Facilities maintenance
• Packing operations

Correct Answer: Quality Assurance (QA)

Q16. If a supplier repeatedly receives major findings during audits, the most appropriate regulatory-compliant action is to:

• Ignore the findings and continue normal ordering
• Place the supplier on probation, increase oversight, and require corrective action plans
• Immediately terminate all contracts without investigation
• Reduce purchase volumes but take no further action

Correct Answer: Place the supplier on probation, increase oversight, and require corrective action plans

Q17. Who is primarily responsible for performing sampling of incoming critical raw materials under GMP?

• Quality Control (QC) personnel following approved sampling procedures
• Only the supplier without company presence
• Logistics staff with no sampling training
• Marketing team

Correct Answer: Quality Control (QC) personnel following approved sampling procedures

Q18. For a newly introduced excipient, what vendor-supplied data is essential to support acceptance and shelf-life assignment?

• Supplier’s corporate logo files
• Stability data and supporting analytical method validation information
• Supplier’s employee handbook
• Supplier sales brochures

Correct Answer: Stability data and supporting analytical method validation information

Q19. Electronic Certificates of Analysis (e-COAs) from a vendor are acceptable provided which condition is met?

• They are emailed with no audit trail
• The electronic system is validated, ensures data integrity, secure transmission and traceability
• They are hand-typed into spreadsheets by purchasing staff
• No validation is required if the supplier is local

Correct Answer: The electronic system is validated, ensures data integrity, secure transmission and traceability

Q20. What is the appropriate supplier obligation regarding notification of changes that may affect product quality or regulatory filings?

• Notify the purchaser only after the change is implemented
• Provide advance (prior) notification and documentation for changes affecting quality or regulatory status
• Never disclose changes due to confidentiality
• Only inform the logistics team

Correct Answer: Provide advance (prior) notification and documentation for changes affecting quality or regulatory status

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