Qualification and validation concepts in QA MCQs With Answer

Qualification and validation concepts in QA MCQs With Answer

This concise introduction explains key qualification and validation concepts for B. Pharm students, covering equipment qualification (IQ, OQ, PQ), process validation, analytical validation, cleaning validation, validation master plan, and regulatory compliance with GMP and quality assurance. Emphasis is on validation lifecycle, risk assessment, protocols, acceptance criteria, documentation, revalidation triggers, and computer system validation to ensure consistent product quality, patient safety, and audit readiness. Understanding these topics helps link theoretical quality principles to practical pharmaceutical operations, documentation and inspections. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of equipment qualification in pharmaceutical QA?

• To document cleaning procedures for the equipment
• To ensure equipment is installed and operates according to specifications
• To validate the analytical method used for product testing
• To perform routine production without interruption

Correct Answer: To ensure equipment is installed and operates according to specifications

Q2. Which stage of qualification verifies performance under simulated or actual operating conditions?

• Installation Qualification (IQ)
• Dry Run Qualification (DRQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Correct Answer: Performance Qualification (PQ)

Q3. What does IQ stand for in qualification terminology?

• Initial Quality
• Installation Qualification
• Instrument Qualification
• Inspection Qualification

Correct Answer: Installation Qualification

Q4. Which document outlines the overall validation strategy for a facility or product line?

• Validation Report
• Validation Master Plan (VMP)
• Standard Operating Procedure (SOP)
• Master Production Record

Correct Answer: Validation Master Plan (VMP)

Q5. Which of the following is a critical element of a validation protocol?

• Color of the equipment paint
• Acceptance criteria and test procedures
• Employee personal preference
• Marketing strategy for the product

Correct Answer: Acceptance criteria and test procedures

Q6. Process validation primarily demonstrates what?

• The manufacturing process is profitable
• The process consistently produces a product meeting predetermined quality attributes
• The analytical method is specific
• The facility layout is optimal

Correct Answer: The process consistently produces a product meeting predetermined quality attributes

Q7. Which validation type assesses analytical methods for accuracy, precision, specificity, linearity and robustness?

• Process Validation
• Analytical Method Validation
• Cleaning Validation
• Installation Qualification

Correct Answer: Analytical Method Validation

Q8. In cleaning validation, a commonly used acceptance approach is based on:

• Employee satisfaction surveys
• Permissible carryover limits and residue limits based on toxicology or 1/1000th dose rules
• Visual inspection only
• Equipment age

Correct Answer: Permissible carryover limits and residue limits based on toxicology or 1/1000th dose rules

Q9. Which guideline is most closely associated with pharmaceutical Quality Management and validation principles?

• ICH Q9 (Quality Risk Management)
• ISO 9001 only
• OECD Good Laboratory Practice only
• ICMP culinary standards

Correct Answer: ICH Q9 (Quality Risk Management)

Q10. What triggers revalidation of a process or equipment?

• A minor cosmetic change to the building facade
• Significant changes in process parameters, equipment, formulation or out-of-specification results
• Routine staff training sessions
• A change in label design

Correct Answer: Significant changes in process parameters, equipment, formulation or out-of-specification results

Q11. Design Qualification (DQ) is primarily concerned with:

• Verifying equipment paint color matches the design book
• Documenting that proposed design meets user and regulatory requirements
• Calibrating analytical instruments
• Cleaning the facility before installation

Correct Answer: Documenting that proposed design meets user and regulatory requirements

Q12. FAT and SAT in qualification stand for:

• Factory Acceptance Test and Site Acceptance Test
• Final Audit Test and Standard Approval Test
• First Authorization Trial and Safety Assessment Test
• Full Assembly Test and System Audit Test

Correct Answer: Factory Acceptance Test and Site Acceptance Test

Q13. Which is an appropriate characteristic to evaluate during analytical method validation?

• Employee attendance
• Sensitivity (LOD and LOQ)
• Facility parking capacity
• Marketing approvals

Correct Answer: Sensitivity (LOD and LOQ)

Q14. Computerized System Validation (CSV) requires:

• Only visual verification that screens look good
• Risk-based approach, requirement specifications, testing, and controlled change management
• No documentation if the system is cloud-based
• Only vendor certificates without testing

Correct Answer: Risk-based approach, requirement specifications, testing, and controlled change management

Q15. What is an Out of Specification (OOS) result?

• A result that is within the specified acceptance limits
• A deviation from expected financial forecasts
• A test result that falls outside defined acceptance criteria
• A scheduled maintenance notification

Correct Answer: A test result that falls outside defined acceptance criteria

Q16. Which statistical measure is commonly used to assess process capability?

• Cp and Cpk indices
• Mean absolute deviation only
• Skewness alone
• Visual histogram color

Correct Answer: Cp and Cpk indices

Q17. The purpose of a validation report is to:

• Provide marketing information to customers
• Summarize validation activities, results, deviations and conclusions
• Replace the validation protocol
• Record employee birthdays

Correct Answer: Summarize validation activities, results, deviations and conclusions

Q18. Which activity is NOT typically part of Operational Qualification (OQ)?

• Testing alarms, interlocks and control limits
• Verifying software logic and sequence of operations
• Long-term production stability over months
• Confirming instrument performance across set ranges

Correct Answer: Long-term production stability over months

Q19. Cleaning validation sampling can use which of the following approaches?

• Swab and rinse sampling with validated analytical methods
• Only visual inspection without chemical testing
• Employee tasting for residues
• Sampling by random public volunteers

Correct Answer: Swab and rinse sampling with validated analytical methods

Q20. Which element is essential when writing acceptance criteria for validation?

• They must be subjective and flexible
• They must be predefined, objective and measurable
• They should be decided after the test results are known
• They should depend on staff preferences

Correct Answer: They must be predefined, objective and measurable

Q21. Media fill studies are most relevant to validating which process?

• Packaging label printing
• Aseptic manufacturing operations
• Chemical stability testing
• Analytical method linearity

Correct Answer: Aseptic manufacturing operations

Q22. What is the role of risk assessment in validation planning?

• To eliminate all documentation requirements
• To identify critical process parameters and prioritize validation activities
• To ensure marketing materials meet design standards
• To replace performance qualification entirely

Correct Answer: To identify critical process parameters and prioritize validation activities

Q23. Which of the following best describes revalidation frequency?

• Revalidation is never required once initial validation is complete
• Revalidation is performed periodically and when changes or failures occur
• Revalidation is only required for new products
• Revalidation should occur daily

Correct Answer: Revalidation is performed periodically and when changes or failures occur

Q24. Which documentation typically follows successful execution of a validation protocol?

• Validation report summarizing results and conclusions
• Only handwritten notes in a personal diary
• An unrelated marketing flyer
• A verbal statement with no record

Correct Answer: Validation report summarizing results and conclusions

Q25. What is a critical quality attribute (CQA)?

• A property that has no impact on product efficacy or safety
• A physical, chemical or microbiological property that must be controlled to ensure product quality
• An attribute related only to packaging aesthetics
• An employee performance metric

Correct Answer: A physical, chemical or microbiological property that must be controlled to ensure product quality

Q26. Which is a common acceptance criterion for sterilization validation?

• 100% visual sterility assurance
• Biological indicator kill data demonstrating required log reduction
• Employee opinion poll on sterility
• Color matching of packaging to a standard

Correct Answer: Biological indicator kill data demonstrating required log reduction

Q27. Change control in validation context is used to:

• Log cosmetic changes only
• Manage and evaluate the impact of changes on validated state and trigger revalidation if needed
• Authorize marketing campaigns
• Avoid documenting deviations

Correct Answer: Manage and evaluate the impact of changes on validated state and trigger revalidation if needed

Q28. Which practice helps ensure ongoing validated state after initial validation?

• Ignoring trends in process data
• Continuous monitoring, calibration, preventive maintenance and periodic review
• Changing protocols frequently without review
• Removing acceptance criteria to simplify testing

Correct Answer: Continuous monitoring, calibration, preventive maintenance and periodic review

Q29. During method validation, robustness testing evaluates:

• How method performance is affected by small deliberate changes in method parameters
• Only the user-friendliness of the method software
• The cost of reagents over time
• Employee satisfaction with the laboratory environment

Correct Answer: How method performance is affected by small deliberate changes in method parameters

Q30. A suitable sampling plan for process validation should be based on:

• Random guesses by production staff
• Statistical rationale, criticality of attributes, and regulatory expectations
• Marketing deadlines only
• Personal preferences of QA managers

Correct Answer: Statistical rationale, criticality of attributes, and regulatory expectations

G S Sachin

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