Validation and qualification types MCQs With Answer

Introduction

This quiz set focuses on validation and qualification types, a core area of Good Regulatory Practices for M.Pharm students. These MCQs are designed to deepen understanding of concepts such as design, installation, operational and performance qualifications (DQ, IQ, OQ, PQ), process validation (prospective, concurrent, retrospective), cleaning and analytical method validation, computerised system validation, and revalidation strategies. Emphasis is placed on regulatory expectations, documentation requirements, acceptance criteria, risk-based approaches, and common pitfalls encountered during validation campaigns. Attempting these questions will help you integrate theoretical knowledge with practical regulatory application, preparing you for exams and industry responsibilities.

Q1. Which statement best defines Design Qualification (DQ)?

• Documented evidence that the chosen design of facilities, systems or equipment is suitable for the intended purpose
• Recorded verification that installed equipment operates within specified limits
• Proof that the production process consistently yields product meeting predetermined quality attributes
• Confirmation that routine calibration meets traceability requirements

Correct Answer: Documented evidence that the chosen design of facilities, systems or equipment is suitable for the intended purpose

Q2. Installation Qualification (IQ) primarily verifies which of the following?

• That the equipment performs consistently under normal operating conditions
• That the equipment is installed correctly and all utilities, components and documentation are present
• That the product meets stability acceptance criteria over shelf-life
• That the manufacturing process yields consistent quality attributes

Correct Answer: That the equipment is installed correctly and all utilities, components and documentation are present

Q3. Operational Qualification (OQ) should demonstrate:

• The process is validated across commercial batches
• The equipment or system operates within established operating ranges and alarms function
• The facility layout prevents cross-contamination
• The analytical method is precise and accurate across its range

Correct Answer: The equipment or system operates within established operating ranges and alarms function

Q4. Performance Qualification (PQ) focuses on which objective?

• Verifying the equipment was built according to specifications
• Confirming the process produces acceptable product under simulated or routine production conditions
• Ensuring design inputs match user requirements
• Documenting maintenance schedules for critical utilities

Correct Answer: Confirming the process produces acceptable product under simulated or routine production conditions

Q5. Which type of validation is performed before routine production to confirm a new process will deliver consistent quality?

• Retrospective validation
• Concurrent validation
• Prospective validation
• Cleaning validation

Correct Answer: Prospective validation

Q6. Retrospective validation is most appropriate when:

• Introducing a new commercial process for the first time
• No historical production and test data are available
• There is a significant historical batch record demonstrating consistency and regulatory acceptance
• Validating a computerized system

Correct Answer: There is a significant historical batch record demonstrating consistency and regulatory acceptance

Q7. In cleaning validation, the concept of ‘worst-case’ is used to:

• Identify the least toxic product for safety assessment
• Select the most difficult-to-remove product or hardest-to-clean location to challenge the cleaning process
• Determine the minimal sample size required for statistical power
• Specify the typical production batch for validation runs

Correct Answer: Select the most difficult-to-remove product or hardest-to-clean location to challenge the cleaning process

Q8. Which statement best describes Process Validation lifecycle as per modern regulatory guidance?

• Validation is a one-time activity completed before commercial release and never revisited
• Validation lifecycle includes process design, process qualification and continued process verification
• Only large-scale batches need validation; small batches are exempt
• Cleaning validation is part of design qualification

Correct Answer: Validation lifecycle includes process design, process qualification and continued process verification

Q9. Which of the following is a primary objective of Computerised System Validation (CSV)?

• To ensure paper records are replaced by electronic signatures only
• To demonstrate that the computerized system is fit for intended use and data integrity is maintained
• To validate the manufacturing process rather than the software
• To confirm user training is not required for system operation

Correct Answer: To demonstrate that the computerized system is fit for intended use and data integrity is maintained

Q10. Which validation approach uses planned samples from production batches while manufacturing is occurring?

• Prospective validation
• Concurrent validation
• Continuous process verification
• Retrospective validation

Correct Answer: Concurrent validation

Q11. Analytical method validation should demonstrate which key parameters?

• Design qualification and IQ only
• Specificity, accuracy, precision, linearity, range, limit of detection and limit of quantitation
• Only robustness and system suitability
• Batch-to-batch variability of finished product

Correct Answer: Specificity, accuracy, precision, linearity, range, limit of detection and limit of quantitation

Q12. What is the main purpose of a Validation Master Plan (VMP)?

• To list only the equipment inventory without timelines
• To define scope, responsibilities, strategy, schedule and documentation for validation activities
• To document every calibration certificate for instruments
• To replace the need for individual validation protocols

Correct Answer: To define scope, responsibilities, strategy, schedule and documentation for validation activities

Q13. Which statement describes revalidation triggers?

• Revalidation is only required every five years irrespective of change
• Revalidation is triggered by process changes, deviations, changes in materials or regulatory findings
• Once validated, processes never require revalidation
• Revalidation applies only to analytical methods

Correct Answer: Revalidation is triggered by process changes, deviations, changes in materials or regulatory findings

Q14. Bracketing and matrixing are strategies used to:

• Reduce the extent of validation testing while still ensuring representative coverage of variables such as strength and container size
• Increase the number of validation runs to guarantee statistical significance
• Only apply to cleaning validation of shared equipment
• Define acceptance criteria for environmental monitoring

Correct Answer: Reduce the extent of validation testing while still ensuring representative coverage of variables such as strength and container size

Q15. Which is a correct distinction between IQ, OQ and PQ?

• IQ: performance under routine conditions; OQ: installation checks; PQ: design review
• IQ: installation and documentation; OQ: function and operating limits; PQ: performance under simulated/routine production
• IQ: analytical validation; OQ: cleaning validation; PQ: calibration
• IQ: process validation; OQ: stability testing; PQ: packaging validation

Correct Answer: IQ: installation and documentation; OQ: function and operating limits; PQ: performance under simulated/routine production

Q16. Which acceptance criterion is most appropriate for OQ tests of a sterilizer?

• Operator preference for cycle duration
• Specified temperature and time parameters achieved uniformly and alarm setpoints validated
• Cleaning agent residue limits
• Stability indicating assay results for finished product

Correct Answer: Specified temperature and time parameters achieved uniformly and alarm setpoints validated

Q17. Which of the following best describes ‘continued process verification’?

• Single qualification run performed at commercial start-up
• Ongoing collection and analysis of process performance and product quality data to ensure the process remains in control
• Only revalidating processes after regulatory audits
• Testing final product stability beyond shelf-life

Correct Answer: Ongoing collection and analysis of process performance and product quality data to ensure the process remains in control

Q18. During method validation, robustness testing evaluates:

• How the method performs under small, deliberate variations in method parameters
• Only the accuracy at a single concentration
• Whether the laboratory layout meets ergonomic standards
• Suitability of raw material vendors

Correct Answer: How the method performs under small, deliberate variations in method parameters

Q19. Which documentation is essential to demonstrate traceability during qualification activities?

• Only verbal confirmation from operators
• Protocols, approved acceptance criteria, executed test records, deviations and final reports
• External marketing materials describing product benefits
• Generic checklists without signatures or dates

Correct Answer: Protocols, approved acceptance criteria, executed test records, deviations and final reports

Q20. A risk-based approach to validation implies:

• Applying the same validation extent to all systems regardless of impact
• Prioritizing validation effort and intensity on systems and processes that have the greatest potential impact on patient safety and product quality
• Eliminating the need for documented acceptance criteria
• Only focusing on process yield and not on quality attributes

Correct Answer: Prioritizing validation effort and intensity on systems and processes that have the greatest potential impact on patient safety and product quality

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