Validation Master Plan (VMP) MCQs With Answer

Validation Master Plan (VMP) MCQs With Answer

This short quiz collection is designed for M.Pharm students studying Good Regulatory Practices, focusing on the Validation Master Plan (VMP). The VMP is the foundation of a compliant validation program and defines scope, responsibilities, strategies, acceptance criteria and deliverables across the lifecycle of facilities, systems and processes. These 20 multiple-choice questions probe conceptual knowledge and practical application — from preparation and approval to commissioning, IQ/OQ/PQ, computerised systems and change control. Use the questions to test understanding, identify gaps, and prepare for examinations or practical roles in pharmaceutical quality assurance and validation.

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

• To list daily manufacturing schedules and batch records
• To provide detailed equipment maintenance procedures
• To define the overall validation strategy, scope, responsibilities and deliverables for a facility, system or process
• To replace standard operating procedures for operators

Correct Answer: To define the overall validation strategy, scope, responsibilities and deliverables for a facility, system or process

Q2. Which of the following elements should typically be included in a VMP?

• Detailed analytical methods for every product
• Project scope, responsibilities, validation strategy, acceptance criteria and documentation list
• Marketing plans and sales forecasts
• Employee payroll and human resources policies

Correct Answer: Project scope, responsibilities, validation strategy, acceptance criteria and documentation list

Q3. Who is normally responsible for approving the VMP before validation activities begin?

• The manufacturing line supervisor only
• The internal audit team without QA involvement
• Quality Assurance and authorized senior management
• The procurement department

Correct Answer: Quality Assurance and authorized senior management

Q4. At what stage of a project should the VMP be prepared?

• After commercial production has started
• During project initiation and design planning
• Only after equipment installation is finished
• When a regulatory inspection is announced

Correct Answer: During project initiation and design planning

Q5. The VMP should address which part(s) of the lifecycle?

• Only the commissioning and qualification phase
• Only the decommissioning phase
• The entire lifecycle from design and installation to operation, maintenance and decommissioning
• Only production processes, excluding utilities and facilities

Correct Answer: The entire lifecycle from design and installation to operation, maintenance and decommissioning

Q6. Which item is generally NOT part of a VMP?

• Validation strategy and scope
• Individual batch manufacturing SOPs
• Acceptance criteria and testing approach
• Roles, responsibilities and timelines for validation activities

Correct Answer: Individual batch manufacturing SOPs

Q7. What formal tool is commonly referenced in a VMP for applying a risk-based approach?

• Financial risk models only
• Failure Modes and Effects Analysis (FMEA) or other formal risk assessments
• Employee opinion surveys
• Random guessing of high risk areas

Correct Answer: Failure Modes and Effects Analysis (FMEA) or other formal risk assessments

Q8. What is the correct typical sequence for commissioning and qualification activities?

• PQ → OQ → IQ → Commissioning
• Commissioning → IQ → OQ → PQ
• IQ → Commissioning → PQ → OQ
• OQ → PQ → IQ → Commissioning

Correct Answer: Commissioning → IQ → OQ → PQ

Q9. Acceptance criteria in a VMP should be based primarily on which of the following?

• Only historical operator preferences
• User Requirement Specification (URS) and applicable regulatory standards
• Cosmetic appearance of the equipment
• Budget constraints alone

Correct Answer: User Requirement Specification (URS) and applicable regulatory standards

Q10. How should the VMP address periodic review and revalidation?

• State that revalidation is never required after initial qualification
• Define scheduled review intervals and trigger events such as major changes
• Leave review frequency to each operator’s discretion
• Only perform reviews following regulatory citations

Correct Answer: Define scheduled review intervals and trigger events such as major changes

Q11. How should computerised systems be handled in the VMP?

• Be ignored because they are not part of physical validation
• Be referenced with a specific strategy for computerised system validation (CSV) and/or a separate CSV plan
• Be validated only by IT without QA involvement
• Be validated using the same tests as HVAC systems

Correct Answer: Be referenced with a specific strategy for computerised system validation (CSV) and/or a separate CSV plan

Q12. Retrospective validation is acceptable under which circumstance?

• Always acceptable for all new processes
• When prospective validation was not possible and sufficient historical data demonstrates consistent control, with justification
• Only for sterile manufacturing
• Never acceptable under any regulatory environment

Correct Answer: When prospective validation was not possible and sufficient historical data demonstrates consistent control, with justification

Q13. Who typically executes validation activities described in the VMP?

• The validation team (validation specialists) under QA oversight and project management
• External auditors only
• Sales representatives
• Untrained temporary staff

Correct Answer: The validation team (validation specialists) under QA oversight and project management

Q14. Which changes would normally trigger requalification or revalidation per the VMP?

• Changes that do not affect process or product quality
• Minor cosmetic repainting of office walls only
• Changes affecting process parameters, equipment design, utilities or product quality
• Change of cafeteria menu

Correct Answer: Changes affecting process parameters, equipment design, utilities or product quality

Q15. Who prepares validation protocols and who approves them as per common VMP practice?

• Validation specialists prepare protocols and Quality Assurance approves them
• The procurement team prepares and the warehouse approves them
• Operators prepare them and no approval is needed
• Regulatory inspectors prepare and approve them during inspections

Correct Answer: Validation specialists prepare protocols and Quality Assurance approves them

Q16. Which regulatory guidance specifically discusses qualification and validation plans and is commonly cited for preparing a VMP?

• FDA 21 CFR Part 210 (Packaging)
• EU GMP Annex 15 (Qualification and Validation)
• Occupational Safety and Health Administration (OSHA) guidelines
• International Financial Reporting Standards (IFRS)

Correct Answer: EU GMP Annex 15 (Qualification and Validation)

Q17. Performance Qualification (PQ) is intended to demonstrate what?

• That installation complies with vendor recommended paint color
• That the process consistently produces product meeting specifications under simulated or commercial conditions
• Only that the software compiles without errors
• That operators enjoy their work environment

Correct Answer: That the process consistently produces product meeting specifications under simulated or commercial conditions

Q18. What does Installation Qualification (IQ) verify?

• Operational performance under loaded production conditions
• That equipment or system is installed according to design, specifications and documentation
• Long-term stability of the product
• Correctness of marketing claims

Correct Answer: That equipment or system is installed according to design, specifications and documentation

Q19. What is the primary focus of Operational Qualification (OQ)?

• Verifying ongoing supplier invoices
• Verifying that the system operates within defined parameters and functional specifications
• Assessing employee satisfaction
• Recording environmental noise levels only

Correct Answer: Verifying that the system operates within defined parameters and functional specifications

Q20. Should the VMP describe training and competence requirements for personnel involved in validation activities?

• No, training is irrelevant to validation
• Yes, it should specify required training, qualifications and responsibilities for personnel
• Only external consultants need training
• Training details are always left undocumented

Correct Answer: Yes, it should specify required training, qualifications and responsibilities for personnel

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