Types of validation MCQs With Answer

Types of validation MCQs With Answer

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Introduction: This collection of Multiple-Choice Questions (MCQs) on Types of Validation is designed specifically for M.Pharm students preparing for examinations and professional practice in pharmaceutical validation. The questions cover practical and theoretical aspects across validation types—process, equipment, cleaning, analytical, computerised systems, sterilization and aseptic processing—emphasizing regulatory expectations, qualification stages (IQ/OQ/PQ), validation lifecycle, and acceptance criteria. Each MCQ is crafted to deepen understanding of validation strategy, documentation and scientific rationale behind acceptance limits, worst-case selection and revalidation triggers. Use these questions to test knowledge, identify gaps, and reinforce principles required for compliant, science-based validation programs in pharmaceutical manufacturing.

Q1. What is the most accurate definition of “validation” in the pharmaceutical context?

  • Routine monitoring of manufacturing operations
  • Establishing documented evidence that a process operates consistently to produce a product meeting predetermined specifications
  • Verification of analytical test results by an independent laboratory
  • Calibration of manufacturing instruments at regular intervals

Correct Answer: Establishing documented evidence that a process operates consistently to produce a product meeting predetermined specifications

Q2. Which statement best describes prospective validation?

  • Validation performed after several commercial batches are released
  • Validation carried out concurrently with routine production
  • Validation performed before a new product or process is introduced into routine production
  • Validation limited to analytical methods only

Correct Answer: Validation performed before a new product or process is introduced into routine production

Q3. What is the primary objective of Operational Qualification (OQ)?

  • To demonstrate equipment is installed according to design specifications
  • To demonstrate equipment and control systems operate within predetermined limits
  • To demonstrate the process produces products meeting specifications under routine conditions
  • To verify cleaning agents are non-toxic

Correct Answer: To demonstrate equipment and control systems operate within predetermined limits

Q4. The main aim of cleaning validation is to:

  • Prove that sterilization cycles are effective
  • Demonstrate that the cleaning procedure consistently reduces product residues, contaminants and cleaning agents to acceptable limits
  • Ensure production schedules are not delayed by cleaning
  • Establish microbial limits for raw materials

Correct Answer: Demonstrate that the cleaning procedure consistently reduces product residues, contaminants and cleaning agents to acceptable limits

Q5. A media fill (aseptic process simulation) is used to:

  • Validate chemical sterilization of packaging materials
  • Assess the sterility assurance of an aseptic filling process by simulating production with growth media
  • Measure endotoxin levels in sterile products
  • Validate cleaning efficacy for isolators

Correct Answer: Assess the sterility assurance of an aseptic filling process by simulating production with growth media

Q6. In moist heat sterilization, which parameter is commonly used to express cumulative lethality?

  • D-value
  • F0 value
  • Z-value
  • Sterility Assurance Level (SAL)

Correct Answer: F0 value

Q7. Which guideline is commonly used for validation and qualification of computerized systems in pharmaceutical environments?

  • ICH Q7
  • GAMP 5
  • EU GMP Annex 16
  • USP Chapter General Notices

Correct Answer: GAMP 5

Q8. Which of the following is a common trigger for revalidation?

  • Routine calibration of instruments
  • Minor cosmetic changes to packaging labels
  • Significant change in formulation, equipment, process or a failure investigation
  • Changing batch record printers

Correct Answer: Significant change in formulation, equipment, process or a failure investigation

Q9. During analytical method validation, which parameter assesses closeness of agreement between the measured value and the true value?

  • Precision
  • Specificity
  • Accuracy
  • Robustness

Correct Answer: Accuracy

Q10. Which qualification phase demonstrates that the process produces acceptable product under anticipated operating conditions in the production environment?

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

Correct Answer: Performance Qualification (PQ)

Q11. What is the preferred scientific approach to setting acceptance limits for cleaning validation residue levels?

  • Arbitrary limits derived from analytical LOQ
  • Use of toxicological or health-based limits such as an Acceptable Exposure Threshold (AET)
  • 100 ppm fixed limit for all residues
  • Limits based solely on historical cleaning swab data

Correct Answer: Use of toxicological or health-based limits such as an Acceptable Exposure Threshold (AET)

Q12. Which document outlines the overall validation strategy, responsibilities, scope and schedule for validation activities at a facility?

  • Standard Operating Procedure (SOP)
  • Validation Protocol
  • Validation Master Plan (VMP)
  • Batch Manufacturing Record

Correct Answer: Validation Master Plan (VMP)

Q13. Which sterilization method uses a gas and requires extended aeration to remove residues?

  • Steam sterilization
  • Dry heat sterilization
  • Ethylene oxide (EO) sterilization
  • Gamma irradiation

Correct Answer: Ethylene oxide (EO) sterilization

Q14. Between process capability indices Cp and Cpk, which one reflects both process variability and whether the process is centered within specification limits?

  • Cp
  • Cpk
  • Neither Cp nor Cpk
  • Both Cp and Cpk equally

Correct Answer: Cpk

Q15. In cleaning validation, a “worst-case” product for selection typically has which characteristics?

  • Low potency, highly water soluble and low residue potential
  • High potency, low solubility in cleaning media and high carryover potential
  • Neutral pH and small production batch size
  • Single-component liquid formulation with no preservatives

Correct Answer: High potency, low solubility in cleaning media and high carryover potential

Q16. Which activity is primarily performed during Installation Qualification (IQ)?

  • Determining worst-case process parameters for production runs
  • Verifying equipment is installed according to design, drawings and supplier specifications
  • Conducting media-fill simulations
  • Establishing cleaning acceptance criteria

Correct Answer: Verifying equipment is installed according to design, drawings and supplier specifications

Q17. Which of the following is NOT a sterility test method for sterile medicinal products?

  • Direct inoculation method
  • Membrane filtration sterility test
  • Rapid microbial methods for sterility testing
  • Pyrogen test (rabbit test for fever response)

Correct Answer: Pyrogen test (rabbit test for fever response)

Q18. Which HVAC parameter is most directly used to maintain contamination control between adjacent cleanroom areas?

  • Air humidity
  • Air differential pressure between rooms
  • Air temperature
  • Noise level from air handling units

Correct Answer: Air differential pressure between rooms

Q19. In validation planning, when are bracketing and matrixing approaches appropriate?

  • Only for cleaning validation of a single product
  • To reduce test burden when multiple strengths, sizes or container types share similar composition and manufacturing process
  • For environmental monitoring only
  • To replace full validation with ad hoc testing

Correct Answer: To reduce test burden when multiple strengths, sizes or container types share similar composition and manufacturing process

Q20. According to FDA process validation lifecycle guidance, which are the three main stages of process validation?

  • Design Qualification, Installation Qualification, Operational Qualification
  • Process Development, Stability Testing, Market Surveillance
  • Process Design, Process Qualification, Continued Process Verification
  • Analytical Validation, Cleaning Validation, Computer System Validation

Correct Answer: Process Design, Process Qualification, Continued Process Verification

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