Calibration vs validation MCQs With Answer

Calibration vs validation MCQs With Answer

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Introduction: Calibration vs Validation MCQs With Answer

This quiz compilation is designed for M.Pharm students to deepen understanding of calibration and validation principles in pharmaceutical practice. It covers core concepts such as instrument calibration, method validation, IQ/OQ/PQ stages, regulatory expectations, measurement uncertainty, traceability, acceptance criteria, revalidation triggers and documentation. Questions progress from definitions to applied scenarios and decision-making in laboratory and manufacturing contexts, emphasizing the differences between ensuring an instrument measures accurately (calibration) and confirming that a process or method meets predetermined requirements (validation). Use this set to test knowledge, prepare for exams, and strengthen practical rationale for compliance in regulated environments.

Q1. What is the primary objective of instrument calibration in a pharmaceutical laboratory?

  • To evaluate whether a method is fit for its intended purpose
  • To establish metrological traceability and correct measurement errors
  • To qualify a manufacturing process under operational conditions
  • To validate analytical specificity and robustness

Correct Answer: To establish metrological traceability and correct measurement errors

Q2. Which activity is the main focus of validation rather than calibration?

  • Adjusting an instrument to match a standard
  • Documenting uncertainty of measurement
  • Demonstrating that an analytical method consistently meets acceptance criteria
  • Replacing worn components of an instrument

Correct Answer: Demonstrating that an analytical method consistently meets acceptance criteria

Q3. Which document describes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)?

  • Calibration protocol
  • Validation master plan (VMP)
  • Certificate of calibration
  • Standard operating procedure for cleaning

Correct Answer: Validation master plan (VMP)

Q4. In method validation, which parameter assesses the closeness of measured values to the true value?

  • Precision
  • Robustness
  • Accuracy (Trueness)
  • Specificity

Correct Answer: Accuracy (Trueness)

Q5. Which statement best differentiates verification from validation in pharmaceutical context?

  • Verification confirms that equipment meets user needs; validation confirms supplier quality
  • Verification checks that specified requirements are met; validation ensures the process fulfills intended use
  • Verification is always a regulatory activity; validation is optional
  • Verification and validation are synonymous terms

Correct Answer: Verification checks that specified requirements are met; validation ensures the process fulfills intended use

Q6. How often should critical analytical instruments typically be calibrated?

  • Only when they fail system suitability tests
  • At defined intervals based on risk assessment and manufacturer’s recommendations
  • Never, if method validation has been completed
  • When an inspector requests calibration records

Correct Answer: At defined intervals based on risk assessment and manufacturer’s recommendations

Q7. Which regulatory guidance primarily outlines requirements for validation of analytical procedures in pharmaceuticals?

  • ISO 9001
  • ICH Q2(R1)
  • USP General Chapter Calibration
  • Pharmacopoeia monograph on excipient testing

Correct Answer: ICH Q2(R1)

Q8. What is measurement uncertainty and why is it important in calibration?

  • The absolute difference between two measurements; it is not relevant in calibration
  • A quantitative estimate of the dispersion of values; it informs decision limits and traceability
  • A measure of instrument durability; it determines calibration cost
  • A statistical test used only in method validation

Correct Answer: A quantitative estimate of the dispersion of values; it informs decision limits and traceability

Q9. Which of these is a typical acceptance criterion during Performance Qualification (PQ)?

  • Manufacturer’s serial number alignment
  • System suitability results under routine operating conditions
  • Calibration certificate expiration date
  • Cleaning validation residual limits

Correct Answer: System suitability results under routine operating conditions

Q10. When should revalidation be performed for an analytical method?

  • Only once after initial validation
  • Whenever there is a significant change that could affect method performance
  • Every week regardless of changes
  • Revalidation is unnecessary if calibration is current

Correct Answer: Whenever there is a significant change that could affect method performance

Q11. Which parameter is used to assess the repeatability of an analytical method?

  • Inter-laboratory variability over months
  • Relative standard deviation (RSD) of replicate measurements under same conditions
  • Limit of detection determined by noise only
  • Traceability chain depth

Correct Answer: Relative standard deviation (RSD) of replicate measurements under same conditions

Q12. What is metrological traceability in the context of calibration?

  • Documenting the history of instrument firmware updates
  • Establishing an unbroken chain of calibrations referenced to national or international standards
  • Ensuring validation protocols are approved by regulatory agencies
  • Tracking lot numbers of reagents used in method validation

Correct Answer: Establishing an unbroken chain of calibrations referenced to national or international standards

Q13. Which validation characteristic ensures an analytical method can unambiguously assess the analyte without interference?

  • Linearity
  • Specificity (Selectivity)
  • Precision
  • Robustness

Correct Answer: Specificity (Selectivity)

Q14. In calibration certificates, what key information must be present to satisfy regulatory expectations?

  • Name of analyst who performed routine testing only
  • Calibration results, uncertainties, reference standards and traceability statement
  • Only the date of calibration without details
  • Full SOP text used in method validation

Correct Answer: Calibration results, uncertainties, reference standards and traceability statement

Q15. Which of the following best describes system suitability testing relative to calibration and validation?

  • An initial calibration activity only
  • A rapid check performed before analytical runs to verify method performance within validated limits
  • A replacement for full method validation
  • A maintenance task unrelated to assay performance

Correct Answer: A rapid check performed before analytical runs to verify method performance within validated limits

Q16. Which ISO standard is most relevant for laboratories performing calibrations and expressing competence?

  • ISO 9000
  • ISO/IEC 17025
  • ISO 13485
  • ISO 14971

Correct Answer: ISO/IEC 17025

Q17. During method validation, what does robustness test primarily evaluate?

  • How precisely an instrument reads a certified standard
  • The effect of small, deliberate variations in method parameters on performance
  • The legal compliance of calibration providers
  • The lifetime of reagents under storage

Correct Answer: The effect of small, deliberate variations in method parameters on performance

Q18. Which action is most appropriate if a calibrated instrument drifts outside specification but the validated method still passes system suitability?

  • Ignore calibration drift because system suitability passed
  • Investigate root cause, perform corrective action and assess impact on past results
  • Immediately discard all method validation data
  • Extend calibration interval to reduce workload

Correct Answer: Investigate root cause, perform corrective action and assess impact on past results

Q19. Which term describes the formal documented demonstration that a specific process will consistently produce a product meeting its predetermined acceptance criteria?

  • Calibration
  • Analytical verification
  • Process validation
  • Metrological confirmation

Correct Answer: Process validation

Q20. For quantitative assays, why is the calibration curve important relative to validation?

  • It replaces the need to document validation parameters
  • It provides the relationship between instrument response and analyte concentration and must remain valid within validated range
  • It ensures the instrument never requires maintenance
  • It is only used for instrument qualification and not for routine testing

Correct Answer: It provides the relationship between instrument response and analyte concentration and must remain valid within validated range

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