Preparation of validation master plan MCQs With Answer

Introduction: The Validation Master Plan (VMP) is a strategic document that outlines the validation strategy, scope, responsibilities, timelines, and documentation for pharmaceutical manufacturing. For B.Pharm students, understanding VMP concepts—such as equipment qualification (DQ/IQ/OQ/PQ), process validation, cleaning validation, computer system validation, risk assessment, and regulatory compliance—is essential for ensuring product quality and patient safety. A well-prepared VMP links validation activities to cGMP requirements, defines acceptance criteria, and describes change control and re‑validation triggers. This guide focuses on practical elements and exam-relevant points to build strong foundations. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a Validation Master Plan (VMP)?

• To list all suppliers for a manufacturing site
• To define the overall validation strategy and scope for a facility
• To describe marketing strategies for a product
• To serve as a batch production record

Correct Answer: To define the overall validation strategy and scope for a facility

Q2. Which element is typically included in a VMP?

• Commercial pricing details
• Validation schedule and milestones
• Patient complaint investigations
• Company annual financial report

Correct Answer: Validation schedule and milestones

Q3. DQ in equipment qualification stands for:

• Design Qualification
• Detail Qualification
• Device Qualification
• Deployment Qualification

Correct Answer: Design Qualification

Q4. Which of the following correctly orders qualification phases?

• IQ, OQ, PQ, DQ
• IQ, PQ, OQ, DQ
• DQ, IQ, OQ, PQ
• PQ, OQ, IQ, DQ

Correct Answer: DQ, IQ, OQ, PQ

Q5. What is the main focus of Process Validation?

• Evaluating supplier financial stability
• Ensuring the process consistently produces quality products
• Certifying personnel training records
• Documenting market research

Correct Answer: Ensuring the process consistently produces quality products

Q6. Which regulatory guidance is often referenced when preparing a VMP?

• ICH Q7 and Q10
• US GAAP accounting standards
• FDA food labeling guidelines
• ISO 9001 only

Correct Answer: ICH Q7 and Q10

Q7. Which document typically follows the VMP to describe specific validation testing?

• Marketing authorization dossier
• Validation protocol
• Purchase order
• Training matrix

Correct Answer: Validation protocol

Q8. What is Acceptance Criteria in a validation protocol?

• Optional suggestions for testing
• Predefined limits that determine if the test is successful
• List of personnel involved in validation
• Supplier contact information

Correct Answer: Predefined limits that determine if the test is successful

Q9. Cleaning validation primarily ensures:

• That cleaning agents are inexpensive
• Removal of residues to acceptable levels to prevent cross-contamination
• Equipment is aesthetically clean
• That detergents are used in excess

Correct Answer: Removal of residues to acceptable levels to prevent cross-contamination

Q10. Which risk assessment tool is commonly used in validation planning?

• SWOT analysis
• Failure Mode and Effects Analysis (FMEA)
• Balance sheet analysis
• Monte Carlo pricing

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q11. Revalidation is required when:

• There is a minor label print change only
• A significant process change or equipment modification occurs
• Training records are updated
• Annual inventory audit is completed

Correct Answer: A significant process change or equipment modification occurs

Q12. Which section of VMP defines roles and responsibilities?

• Scope section
• Responsibilities and organizational structure section
• Appendix with SOPs only
• Financial summary

Correct Answer: Responsibilities and organizational structure section

Q13. Analytical method validation is usually documented in:

• Validation protocol and validation report
• Purchase requisition
• Marketing plan
• HR personnel file

Correct Answer: Validation protocol and validation report

Q14. Which of the following is a key output of PQ (Performance Qualification)?

• Installation instructions for equipment
• Evidence that equipment/process performs as intended under normal production
• Supplier selection criteria
• Budget forecast

Correct Answer: Evidence that equipment/process performs as intended under normal production

Q15. The VMP should be reviewed and approved by:

• Only the production supervisor
• Qualified persons including QA and technical leads
• Marketing department
• External vendors only

Correct Answer: Qualified persons including QA and technical leads

Q16. Computer system validation (CSV) focuses on:

• Software aesthetics
• Data integrity, security, and intended functionality of computerized systems
• Reducing software licensing costs
• Marketing automation tools only

Correct Answer: Data integrity, security, and intended functionality of computerized systems

Q17. Which metric is commonly used to demonstrate process capability during validation?

• Net profit margin
• Cpk (process capability index)
• Employee turnover rate
• Number of suppliers

Correct Answer: Cpk (process capability index)

Q18. A traceability matrix in validation links:

• Personnel names to their salaries
• Requirements to test cases and results
• Purchase orders to invoices
• Marketing claims to ad spend

Correct Answer: Requirements to test cases and results

Q19. Retrospective validation is applied when:

• A new product is introduced
• Historical production data is used to demonstrate consistent performance
• All validation was performed prospectively
• Equipment is never used

Correct Answer: Historical production data is used to demonstrate consistent performance

Q20. Which document summarizes the outcomes and conclusions of validation activities?

• Validation report
• Purchase order
• Training certificate
• Marketing brief

Correct Answer: Validation report

Q21. Which of the following is NOT typically a part of cleaning validation acceptance criteria?

• Maximum allowable carryover limits
• Visual cleanliness criteria
• Targeted residue concentration limits
• Supplier annual revenue

Correct Answer: Supplier annual revenue

Q22. Change control in the context of VMP is used to:

• Track employee holidays
• Manage and document changes that could affect validated state
• Publish marketing changes
• Record customer feedback only

Correct Answer: Manage and document changes that could affect validated state

Q23. Which test is typically performed during OQ (Operational Qualification)?

• Verification of installation location
• Testing equipment under a range of operating conditions
• Company financial audit
• Market acceptability testing

Correct Answer: Testing equipment under a range of operating conditions

Q24. Who is ultimately responsible for product release in many regulatory systems?

• Quality Assurance (QA) only
• Qualified Person (QP) or designated responsible person
• Sales manager
• External auditor

Correct Answer: Qualified Person (QP) or designated responsible person

Q25. A validation matrix typically helps to:

• Map validation activities to equipment and processes
• Calculate production costs
• Hire new staff
• Design product packaging

Correct Answer: Map validation activities to equipment and processes

Q26. Which of the following best describes prospective validation?

• Validation performed after commercial distribution using market complaints
• Validation performed before routine production to demonstrate process capability
• Validation based solely on supplier certifications
• Validation that ignores regulatory guidance

Correct Answer: Validation performed before routine production to demonstrate process capability

Q27. Qualification of utilities (e.g., HVAC, water) ensures:

• Optimal energy billing
• They meet specified performance and quality requirements
• Vendor profit margins
• Only visual cleanliness

Correct Answer: They meet specified performance and quality requirements

Q28. Which item should be part of VMP appendices?

• List of validation SOPs, templates, and forms
• Company picnic photo album
• External market research slide deck
• Product pricing history

Correct Answer: List of validation SOPs, templates, and forms

Q29. During validation, sampling plans should be based on:

• Random guesses
• Risk assessment, scientific rationale and regulatory expectations
• Marketing schedules
• Only supplier recommendations

Correct Answer: Risk assessment, scientific rationale and regulatory expectations

Q30. Which statement best reflects the relationship between qualification and validation?

• Qualification is unrelated to validation
• Qualification demonstrates equipment readiness; validation demonstrates process performance
• Validation replaces the need for qualification
• Qualification is only for office equipment

Correct Answer: Qualification demonstrates equipment readiness; validation demonstrates process performance

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