Validation Concepts – Types, Protocols, Documentation MCQs With Answer

Introduction:

This quiz collection on Validation Concepts – Types, Protocols, Documentation is designed specifically for M.Pharm students studying Scale Up & Technology Transfer (MIP 202T). It reviews core validation principles including process, cleaning, analytical and computerised system validation, and explains the structure and purpose of validation protocols such as IQ, OQ and PQ. Emphasis is placed on documentation practices—Validation Master Plan, protocols, reports—and regulatory expectations, risk-based approaches, and lifecycle thinking. These MCQs reinforce understanding of acceptance criteria, revalidation triggers, transfer considerations and practical testing strategies required for robust pharmaceutical technology transfer.

Q1. Which document outlines the overall strategy, scope, responsibilities and schedule for validation activities across a facility or product portfolio?

• Validation Protocol
• Validation Master Plan
• Validation Report
• Standard Operating Procedure

Correct Answer: Validation Master Plan

Q2. Which qualification step focuses on verifying that equipment is installed according to manufacturer specification and design intentions?

• Performance Qualification (PQ)
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• Design Qualification (DQ)

Correct Answer: Installation Qualification (IQ)

Q3. Which validation type specifically assesses a manufacturing process to ensure consistent production of a product meeting predefined quality attributes?

• Cleaning Validation
• Process Validation
• Analytical Method Validation
• Equipment Qualification

Correct Answer: Process Validation

Q4. Which protocol contains the detailed test plan, acceptance criteria, sampling plans and responsibilities for validating a system or process?

• Validation Master Plan
• Validation Report
• Validation Protocol
• Change Control Request

Correct Answer: Validation Protocol

Q5. In cleaning validation, the concept of “worst-case” is used to select target products and surfaces. What does “worst-case” typically refer to?

• The product with the lowest solubility in cleaning agents
• The product with the highest therapeutic index
• The product with the simplest formulation to clean
• The product with the shortest shelf-life

Correct Answer: The product with the lowest solubility in cleaning agents

Q6. Which validation activity is primarily intended to confirm that an analytical method is suitable for its intended purpose (e.g., specificity, accuracy, precision)?

• Analytical Method Validation
• Process Validation
• Computer System Validation
• Cleaning Validation

Correct Answer: Analytical Method Validation

Q7. Which document is produced after completing validation tests and summarizes results, deviations, conclusions and recommendations?

• Validation Protocol
• Validation Master Plan
• Validation Report
• User Requirement Specification

Correct Answer: Validation Report

Q8. Which validation approach emphasises identifying and controlling risks to product quality throughout the product lifecycle?

• Deterministic Validation
• Risk-Based Validation
• Retrospective Validation
• Ad-hoc Validation

Correct Answer: Risk-Based Validation

Q9. Which stage of equipment qualification demonstrates that the equipment operates within predetermined limits under simulated and actual process conditions?

• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)

Correct Answer: Performance Qualification (PQ)

Q10. In technology transfer, which document typically specifies how a process or product will be transferred between sites and the acceptance criteria for transfer?

• Transfer Protocol
• Batch Manufacturing Record
• Quality Risk Assessment
• Deviation Report

Correct Answer: Transfer Protocol

Q11. Which type of validation is required for computerized systems that directly affect product quality and includes requirements traceability, configuration control and testing?

• Analytical Validation
• Computer System Validation (CSV)
• Cleaning Validation
• Operational Qualification (OQ)

Correct Answer: Computer System Validation (CSV)

Q12. Which validation tool describes the logical steps linking user needs to system functions and test cases, often used in CSV and equipment qualification?

• Risk Assessment Matrix
• Traceability Matrix
• Deviation Log
• Calibration Schedule

Correct Answer: Traceability Matrix

Q13. Which validation strategy uses bracketing and matrixing to reduce the number of actual tests required while still ensuring adequate coverage?

• Process Analytical Technology
• Design of Experiments
• Statistical Process Control
• Bracketing and Matrixing

Correct Answer: Bracketing and Matrixing

Q14. When is revalidation typically required?

• Only when a product is discontinued
• After any change that may impact process performance or product quality
• Whenever a new batch is produced
• Only during annual calibration

Correct Answer: After any change that may impact process performance or product quality

Q15. What is the primary purpose of an Installation Qualification (IQ) checklist?

• To verify process capability across multiple batches
• To document that equipment was installed according to design and specifications
• To validate analytical method precision
• To confirm cleaning procedures remove residues

Correct Answer: To document that equipment was installed according to design and specifications

Q16. Which validation concept involves running aseptic process simulations using growth media to challenge sterility assurance?

• Media Fill
• Cleaning Challenge Test
• FAT (Factory Acceptance Test)
• Process Capability Study

Correct Answer: Media Fill

Q17. For analytical validation, which parameter measures closeness of agreement between a measured value and the true value?

• Precision
• Specificity
• Accuracy
• Robustness

Correct Answer: Accuracy

Q18. What does retrospective validation refer to?

• Validation performed prospectively before any production batches
• Validation of historical batches using accumulated production data
• Validation focused only on cleaning procedures
• Validation of design specifications

Correct Answer: Validation of historical batches using accumulated production data

Q19. Which document captures acceptance criteria, sampling locations, analytical methods and acceptance limits specifically for cleaning validation?

• Cleaning Validation Protocol
• Equipment Logbook
• Standard Operating Procedure for Training
• Calibration Certificate

Correct Answer: Cleaning Validation Protocol

Q20. Which of the following is a common acceptance criterion approach for cleaning validation when a toxicological-based limit is used?

• LOD-based limit
• 1/100th of the therapeutic dose
• Acceptable Daily Exposure (ADE) or Permissible Daily Exposure (PDE)
• Arbitrary visual cleanliness

Correct Answer: Acceptable Daily Exposure (ADE) or Permissible Daily Exposure (PDE)

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