Validation Master Plan and organization MCQs With Answer is designed to help M.Pharm students master the fundamentals and advanced concepts of validation planning and organizational responsibilities in pharmaceutical manufacturing. This blog focuses on the Validation Master Plan (VMP) — its purpose, structure, lifecycle approach, risk-based strategies, and the roles and responsibilities of cross‑functional teams. Expect questions that probe into qualification stages (DQ/IQ/OQ/PQ), documentation hierarchy, change control triggers, supplier qualification, cleaning validation, computerized system validation, and ongoing revalidation criteria. The MCQs emphasize regulatory expectations and practical implementation to prepare you for academic assessments and real-world validation challenges.
Q1. What is the primary purpose of a Validation Master Plan (VMP)?
- To provide a high-level document describing overall validation strategy, scope, responsibilities, schedule and deliverables
- To replace individual validation protocols for each activity
- To serve only as a training manual for operators
- To list only the equipment serial numbers and purchase dates
Correct Answer: To provide a high-level document describing overall validation strategy, scope, responsibilities, schedule and deliverables
Q2. Who is typically responsible for final approval of the Validation Master Plan?
- Head of Quality Assurance (Quality Unit)
- Plant Maintenance Supervisor
- Purchasing Manager
- Line Operators’ Representative
Correct Answer: Head of Quality Assurance (Quality Unit)
Q3. Which element must a VMP include to prioritize validation activities based on impact to product quality?
- Risk assessment methodology and criticality ranking
- Only a simple alphabetical list of equipment
- Financial depreciation schedule for equipment
- Annual holiday calendar for the validation team
Correct Answer: Risk assessment methodology and criticality ranking
Q4. Which approach best describes the lifecycle covered by a well‑written VMP?
- Lifecycle approach from design to commissioning, operation, maintenance and decommissioning
- Commissioning only, excluding design and operation
- Operation only, with no documentation of commissioning
- Decommissioning only after product discontinuation
Correct Answer: Lifecycle approach from design to commissioning, operation, maintenance and decommissioning
Q5. What is the ideal composition of a validation team as recommended in VMPs?
- Multidisciplinary team with QA, engineering, production, QC, and subject matter experts
- Only QA personnel with no input from other departments
- External consultants only to perform all work
- Single internal technician assigned to all validation tasks
Correct Answer: Multidisciplinary team with QA, engineering, production, QC, and subject matter experts
Q6. What is the correct sequence of qualification activities?
- Design Qualification -> Installation Qualification -> Operational Qualification -> Performance Qualification
- Operational Qualification -> Design Qualification -> Performance Qualification -> Installation Qualification
- Performance Qualification -> Installation Qualification -> Operational Qualification -> Design Qualification
- Installation Qualification -> Performance Qualification -> Operational Qualification -> Design Qualification
Correct Answer: Design Qualification -> Installation Qualification -> Operational Qualification -> Performance Qualification
Q7. What is the purpose of the master validation schedule included in the VMP?
- To list validation projects with timelines, priorities, milestones and resource allocation
- To document the personal leave schedule of validation staff
- To provide a public relations calendar for product launches
- To record the purchase history of spare parts
Correct Answer: To list validation projects with timelines, priorities, milestones and resource allocation
Q8. Which event should trigger a revalidation according to good practice and VMP guidance?
- Any change affecting process, equipment, materials or product quality attributes
- Minor office redecoration near the QA office
- Only when a regulatory inspector requests it
- Every time a new hire joins the validation team
Correct Answer: Any change affecting process, equipment, materials or product quality attributes
Q9. What is the correct documentation hierarchy for validation activities?
- Validation Master Plan -> Validation Protocols -> Validation Reports
- Validation Reports -> Validation Master Plan -> Validation Protocols
- Individual SOPs only without any master plan
- Training records -> Validation Master Plan -> Equipment invoices
Correct Answer: Validation Master Plan -> Validation Protocols -> Validation Reports
Q10. How should acceptance criteria in validation protocols be defined?
- Predefined measurable limits based on critical quality attributes (CQAs) and regulatory requirements
- Arbitrarily chosen values after testing is complete
- General statements like “acceptable” without numeric limits
- Based solely on supplier recommendations
Correct Answer: Predefined measurable limits based on critical quality attributes (CQAs) and regulatory requirements
Q11. When is prospective validation performed versus retrospective validation?
- Prospective for new products/processes before distribution; retrospective for historical data review of existing processes
- Prospective only after products fail testing; retrospective only before launch
- Prospective for cleaning only; retrospective for equipment only
- Both are performed randomly without relation to product lifecycle
Correct Answer: Prospective for new products/processes before distribution; retrospective for historical data review of existing processes
Q12. What role does Quality Risk Management (QRM) play in the VMP?
- To identify, assess and control risks to ensure CQAs are met and to define critical process parameters (CPPs)
- To replace all analytical testing with judgmental decisions
- To determine marketing strategies for new products
- To assign blame after deviations occur without preventive measures
Correct Answer: To identify, assess and control risks to ensure CQAs are met and to define critical process parameters (CPPs)
Q13. Which document typically defines roles and responsibilities for validation activities?
- Validation Master Plan
- Purchase Order
- Payroll Schedule
- Building Floor Plan
Correct Answer: Validation Master Plan
Q14. Should supplier and outsourced service qualification be included in the VMP?
- Yes, a supplier and outsourced service qualification strategy should be included
- No, suppliers are not relevant to validation
- Only if the supplier is outside the country
- Only for suppliers of office supplies
Correct Answer: Yes, a supplier and outsourced service qualification strategy should be included
Q15. How is cleaning validation typically addressed within a VMP?
- As a cleaning validation strategy with selection of worst-case products, acceptance criteria and sampling plan
- By documenting only the detergent brand used
- By visual inspection only with no analytical support
- By relying solely on the production team’s opinion
Correct Answer: As a cleaning validation strategy with selection of worst-case products, acceptance criteria and sampling plan
Q16. Which of the following best describes when revalidation is mandatory?
- After significant process/equipment/formulation changes, periodic review, or when trending and quality data indicate deterioration
- Only when an inspector requests it and never otherwise
- Every time the company changes its logo
- Revalidation is never mandatory if initial validation passed
Correct Answer: After significant process/equipment/formulation changes, periodic review, or when trending and quality data indicate deterioration
Q17. What is the primary purpose of a validation traceability or matrix?
- To map process steps, controls, tests and responsibility for verification of CQAs and CPPs
- To list employee birthdays for the validation team
- To show the physical location of fire extinguishers
- To document vendor contact details only
Correct Answer: To map process steps, controls, tests and responsibility for verification of CQAs and CPPs
Q18. How often should the VMP be formally reviewed?
- Reviewed periodically (at least annually) and whenever significant changes occur
- Only once at initial creation and never again
- Every ten years irrespective of changes
- Only when a product is discontinued
Correct Answer: Reviewed periodically (at least annually) and whenever significant changes occur
Q19. Who is typically responsible for retaining validation records and reports?
- Quality Assurance (QA) maintains validation records per retention policy
- Production line staff keeps all validation reports in their lockers
- External contractors keep primary copies without QA oversight
- Human Resources stores validation PDFs in personal files
Correct Answer: Quality Assurance (QA) maintains validation records per retention policy
Q20. How should Computerized System Validation (CSV) be addressed within the VMP?
- Include CSV approach covering lifecycle, risk‑based testing, traceability, data integrity and change control
- CSV can be ignored because computers are not critical for quality
- Only document user names and passwords without validation testing
- CSV should be outsourced with no internal oversight or documentation
Correct Answer: Include CSV approach covering lifecycle, risk‑based testing, traceability, data integrity and change control
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com