Validation is a cornerstone of pharmaceutical manufacturing, ensuring that processes, equipment, cleaning, and computerized systems consistently deliver safe, effective medicines. For B.Pharm students, understanding validation concepts—process validation, equipment qualification (DQ/IQ/OQ/PQ), cleaning validation, analytical method validation, and computerized system validation—is essential for regulatory compliance and Good Manufacturing Practice (GMP). Validation reduces product risk, prevents cross-contamination, and provides documented evidence through protocols, reports, and change control. Emphasis on validation documentation, validation master plan (VMP), statistical monitoring, and risk-based approaches will deepen your practical skills. These MCQs cover theory, practical examples, regulatory expectations, and problem-solving scenarios to prepare you for exams and industry. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of process validation in pharmaceutical manufacturing?
- To verify that each raw material meets supplier specifications
- To confirm that a process consistently produces a product meeting predetermined quality attributes
- To ensure finished product packaging is tamper-evident
- To document employee training records
Correct Answer: To confirm that a process consistently produces a product meeting predetermined quality attributes
Q2. Which document typically outlines the company-wide approach to validation activities?
- Batch Manufacturing Record (BMR)
- Standard Operating Procedure (SOP) for cleaning
- Validation Master Plan (VMP)
- Change Control Form
Correct Answer: Validation Master Plan (VMP)
Q3. What are the stages of equipment qualification?
- Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Material Qualification, Process Qualification, Product Qualification
- Raw Material Testing, In-Process Testing, Final Testing
- Design Review, Production Run, Marketing Approval
Correct Answer: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Q4. Which type of validation is most appropriate for sterile aseptic filling?
- Analytical method validation
- Process validation with media fills
- Cleaning validation only
- Packaging validation
Correct Answer: Process validation with media fills
Q5. What is the main goal of cleaning validation?
- To reduce utility costs
- To ensure removal of product residues, cleaning agents, and microbial contamination to acceptable levels
- To validate employee cleaning techniques
- To verify label accuracy
Correct Answer: To ensure removal of product residues, cleaning agents, and microbial contamination to acceptable levels
Q6. Which regulatory guideline is commonly referenced for pharmaceutical validation?
- ICH Q7 and ICH Q8 only
- Good Clinical Practice (GCP)
- ICH Q8/Q9/Q10 and relevant GMP regulations
- Pharmacopoeial monographs exclusively
Correct Answer: ICH Q8/Q9/Q10 and relevant GMP regulations
Q7. In equipment qualification, what does IQ verify?
- That the equipment operates under production conditions
- That the equipment design meets user needs
- That the equipment is installed according to specifications
- That the process yields are acceptable
Correct Answer: That the equipment is installed according to specifications
Q8. What is ‘worst-case’ selection in validation planning?
- Selecting the easiest-to-control scenario for validation
- Choosing the most challenging conditions within normal operating ranges to demonstrate robustness
- Picking the most expensive materials for testing
- Using historical data without experimental verification
Correct Answer: Choosing the most challenging conditions within normal operating ranges to demonstrate robustness
Q9. Which validation type ensures that analytical methods produce reliable data?
- Process validation
- Analytical method validation
- Cleaning validation
- Computer system validation
Correct Answer: Analytical method validation
Q10. Which parameter is NOT typically assessed during analytical method validation?
- Accuracy
- Precision
- Linearity
- Color of the reagent bottle
Correct Answer: Color of the reagent bottle
Q11. What triggers revalidation of a process?
- Minor cleaning schedule adjustments without risk assessment
- Significant process changes, equipment modification, or failed trends indicating loss of control
- Routine monthly production runs within validated limits
- Employee turnover in marketing
Correct Answer: Significant process changes, equipment modification, or failed trends indicating loss of control
Q12. What is the purpose of a validation protocol?
- To describe the marketing strategy for the product
- To detail objectives, acceptance criteria, test plans, and responsibilities for validation
- To record employee performance reviews
- To list suppliers for raw materials
Correct Answer: To detail objectives, acceptance criteria, test plans, and responsibilities for validation
Q13. Which statistical tool is commonly used to monitor process capability during validation?
- Control charts and process capability indices (Cp, Cpk)
- Financial ROI analysis
- Histogram of employee ages
- UV spectral scans only
Correct Answer: Control charts and process capability indices (Cp, Cpk)
Q14. What is computerized system validation (CSV) focused on?
- Validating raw material suppliers
- Ensuring software and IT systems perform intended functions and maintain data integrity
- Assessing the sterility of a product
- Cleaning validation of laboratory glassware
Correct Answer: Ensuring software and IT systems perform intended functions and maintain data integrity
Q15. During process validation, what is the role of ‘acceptance criteria’?
- They define the marketing claims for the product
- They establish measurable limits that determine whether the process is acceptable
- They list employees authorized to sign documents
- They are optional suggestions with no regulatory importance
Correct Answer: They establish measurable limits that determine whether the process is acceptable
Q16. What is ‘prospective validation’?
- Validation performed after a process has been used in commercial production
- Validation carried out during the development of a process before routine production
- Validation based solely on literature without experiments
- Validation of marketing claims
Correct Answer: Validation carried out during the development of a process before routine production
Q17. Which is a key output of a validation exercise?
- Validation report summarizing results, deviations, conclusions, and recommendations
- Only the raw test data without interpretation
- Marketing materials for the product launch
- Supplier invoices
Correct Answer: Validation report summarizing results, deviations, conclusions, and recommendations
Q18. What is the main risk addressed by cleaning validation in multi-product facilities?
- Product labeling errors
- Cross-contamination between successive products
- Incorrect storage conditions
- Poor employee hygiene
Correct Answer: Cross-contamination between successive products
Q19. Which factor is important when selecting sampling locations for cleaning validation?
- Areas that are hardest to clean and most likely to retain residues
- Only the cleanest possible surfaces
- Locations near the factory entrance
- Random office desks
Correct Answer: Areas that are hardest to clean and most likely to retain residues
Q20. What is the significance of Design Qualification (DQ)?
- It verifies that the equipment is available in the warehouse
- It documents that the proposed design meets user and regulatory requirements
- It confirms the manufacturing date of equipment
- It is a marketing document
Correct Answer: It documents that the proposed design meets user and regulatory requirements
Q21. Which validation approach uses risk assessment to prioritize activities?
- Risk-based validation
- Destructive validation
- Random validation
- Cosmetic validation
Correct Answer: Risk-based validation
Q22. What is an example of a critical process parameter (CPP)?
- Ambient office temperature
- Tablet compression force affecting dissolution
- Brand color of the packaging
- Employee staffing levels
Correct Answer: Tablet compression force affecting dissolution
Q23. In cleaning validation, what does TOC measurement assess?
- Total organic carbon to detect organic residues
- Total oxidative capacity of detergents
- Time of cleaning
- Temperature of cleaning solution
Correct Answer: Total organic carbon to detect organic residues
Q24. What is the role of change control in validation lifecycle?
- To allow unlimited undocumented changes
- To evaluate and document impacts of changes on validated state and trigger revalidation if needed
- To record holidays
- To change employee job titles
Correct Answer: To evaluate and document impacts of changes on validated state and trigger revalidation if needed
Q25. Which of the following is a typical acceptance criterion for sterilization validation?
- Bioburden reduction to a specified log reduction and sterility assurance level (SAL)
- Visual clarity of the sterilization chamber
- Operator preference for cycle time
- Packaging color matching
Correct Answer: Bioburden reduction to a specified log reduction and sterility assurance level (SAL)
Q26. What does PQ (Performance Qualification) verify?
- That the system is installed as per drawings
- That the process performs as intended under simulated worst-case conditions and routine production
- That suppliers are GMP certified
- That financial projections are accurate
Correct Answer: That the process performs as intended under simulated worst-case conditions and routine production
Q27. Which document records all deviations observed during validation runs?
- Validation deviation report or non-conformance report
- Employee payroll sheet
- Marketing budget
- Supplier price list
Correct Answer: Validation deviation report or non-conformance report
Q28. What is the difference between verification and validation?
- Verification checks that you built the system right; validation ensures you built the right system to meet user needs
- They are identical terms with no difference
- Verification is only for marketing, validation is only for manufacturing
- Verification applies to packaging only, validation to formulations only
Correct Answer: Verification checks that you built the system right; validation ensures you built the right system to meet user needs
Q29. Which monitoring practice helps detect trends that may require revalidation?
- Routine trending of critical quality attributes and process parameters
- Random social media checks
- Monthly cafeteria surveys
- Annual company picnic attendance
Correct Answer: Routine trending of critical quality attributes and process parameters
Q30. Why is documentation critical in validation?
- Because auditors and regulators require evidence that processes are controlled and validated
- Because it reduces the need for training
- Because it speeds up production regardless of quality
- Because it increases packaging costs
Correct Answer: Because auditors and regulators require evidence that processes are controlled and validated
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