Qualification of FTIR MCQs With Answer

Qualification of FTIR MCQs With Answer

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Introduction

This collection of MCQs on Qualification of FTIR is designed specifically for M.Pharm students studying Pharmaceutical Validation. The questions cover core concepts such as instrument installation, operational and performance qualification (IQ/OQ/PQ), routine performance checks, important performance tests (wavenumber accuracy, resolution, signal-to-noise), sampling techniques (ATR, transmission, diffuse reflectance), software validation, spectral libraries, and regulatory considerations. Each question emphasizes practical aspects used in pharmaceutical laboratories — standards, troubleshooting, documentation and decision rules — to prepare you for both examinations and real-world instrument qualification tasks. Answers are provided to help reinforce learning and identify areas for review.

Q1. What is the primary objective of qualifying an FTIR instrument in a pharmaceutical laboratory?

  • To ensure instrument meets performance specifications for accurate and reproducible spectral data
  • To verify the chemical composition of unknown samples only once
  • To reduce the cost of consumables used with the instrument
  • To demonstrate compliance with GMP by documenting every spectrum

Correct Answer: To ensure instrument meets performance specifications for accurate and reproducible spectral data

Q2. During Installation Qualification (IQ) of an FTIR, which activity is essential?

  • Verifying that the instrument was installed according to manufacturer and site specifications
  • Performing a full method validation for all assays
  • Running routine sample analyses under production conditions
  • Updating the spectral library with new spectra

Correct Answer: Verifying that the instrument was installed according to manufacturer and site specifications

Q3. Which reference material is commonly used to check wavenumber accuracy of FTIR spectrometers?

  • Polystyrene film
  • Sodium chloride crystal
  • Potassium bromide powder
  • Calcium fluoride window

Correct Answer: Polystyrene film

Q4. Which performance test is most appropriate to assess spectral resolution of an FTIR?

  • Measurement of the width and separation of narrow peaks in a polystyrene standard
  • Quantifying baseline drift over time with no sample
  • Measuring the intensity of a single broad band in water
  • Comparing total absorbance at a single wavenumber

Correct Answer: Measurement of the width and separation of narrow peaks in a polystyrene standard

Q5. What does the signal-to-noise (S/N) test evaluate for an FTIR during OQ?

  • The ability to detect spectral features above baseline noise
  • The accuracy of wavenumber calibration
  • The alignment of the detector with the beam path
  • The stability of sample temperature in the cell

Correct Answer: The ability to detect spectral features above baseline noise

Q6. How should the frequency of routine FTIR performance verification be defined?

  • In an SOP based on instrument usage, regulatory expectations and risk assessment
  • Only once at installation and never again unless failure occurs
  • Daily for all instruments regardless of use or risk
  • Whenever a new analyst uses the instrument

Correct Answer: In an SOP based on instrument usage, regulatory expectations and risk assessment

Q7. Which sampling accessory is most effective for rapid analysis of solids with minimal sample preparation?

  • Attenuated Total Reflectance (ATR) accessory
  • Transmission KBr pellet cell
  • Gas-phase long-path cell
  • Liquid film cell with NaCl windows

Correct Answer: Attenuated Total Reflectance (ATR) accessory

Q8. Which instrument factors most directly affect wavenumber accuracy in an FTIR?

  • Optical alignment, interferometer calibration and beam splitter quality
  • Choice of detector cooling method only
  • Sample holder material without any optical alignment issues
  • Number of co-added scans only

Correct Answer: Optical alignment, interferometer calibration and beam splitter quality

Q9. What is the main goal of validating FTIR acquisition and processing software used for regulated analyses?

  • To ensure the software performs intended functions reliably and maintains audit trails and data integrity
  • To make the software more user-friendly with custom themes
  • To reduce instrument noise by changing acquisition algorithms casually
  • To allow unrestricted modification of spectral libraries by all users

Correct Answer: To ensure the software performs intended functions reliably and maintains audit trails and data integrity

Q10. Which international guideline is most commonly referenced for analytical method validation applicable to FTIR-based methods?

  • ICH Q2(R1)
  • ISO 9001
  • GMP Annex 1
  • ICH Q8

Correct Answer: ICH Q2(R1)

Q11. For quantitative FTIR using chemometrics, which element is essential during method qualification?

  • Robust calibration models built from representative reference standards and validation sets
  • Only using a single sample to build the model
  • Ignoring matrix variability to simplify the model
  • Relying solely on default spectral libraries for quantitation

Correct Answer: Robust calibration models built from representative reference standards and validation sets

Q12. Which sampling approach most effectively minimizes scattering and particle size effects for solid powders in FTIR?

  • Using ATR sampling to measure surface contact spectra
  • Making a thick diffuse reflectance sample without any preparation
  • Increasing detector gain until peaks appear
  • Using an open-air measurement without a background

Correct Answer: Using ATR sampling to measure surface contact spectra

Q13. If a routine polystyrene wavenumber test fails during OQ, what is the appropriate next step?

  • Investigate, troubleshoot optics and alignment, repeat the test and document corrective actions
  • Ignore the failure if sample spectra look acceptable
  • Immediately discard the instrument without any investigation
  • Change the spectral library and re-run samples

Correct Answer: Investigate, troubleshoot optics and alignment, repeat the test and document corrective actions

Q14. Why is acquiring a background spectrum important before sample measurement in FTIR?

  • To remove atmospheric and instrument contributions such as CO2 and water from sample spectra
  • To calibrate the detector temperature for better cooling
  • To align the sample tray automatically
  • To increase the sample concentration artificially

Correct Answer: To remove atmospheric and instrument contributions such as CO2 and water from sample spectra

Q15. What is the purpose of purging the FTIR optical path with dry nitrogen during qualification?

  • To reduce interference from water vapor and carbon dioxide in the spectra
  • To cool the detector to cryogenic temperatures
  • To clean the sample surface mechanically
  • To improve the resolution beyond instrument capability

Correct Answer: To reduce interference from water vapor and carbon dioxide in the spectra

Q16. Increasing spectral resolution (e.g., from 8 cm-1 to 1 cm-1) will generally have which effect?

  • Improve separation of closely spaced peaks but increase noise and acquisition time
  • Decrease the number of scans required for acceptable S/N
  • Eliminate the need for background subtraction
  • Reduce sensitivity to small spectral features

Correct Answer: Improve separation of closely spaced peaks but increase noise and acquisition time

Q17. Which activity is NOT typically part of Performance Qualification (PQ) for an FTIR instrument?

  • Factory acceptance testing performed by the manufacturer prior to delivery
  • Demonstrating instrument performance under normal laboratory operating conditions
  • Running representative routine samples to confirm suitability for intended use
  • Documenting reproducibility and pass/fail criteria over time

Correct Answer: Factory acceptance testing performed by the manufacturer prior to delivery

Q18. For identity testing of an active pharmaceutical ingredient (API) using FTIR, what approach provides the most robust result?

  • Matching sample spectrum to a validated reference spectrum or library with defined acceptance criteria
  • Visual comparison of spectra without defined match criteria
  • Using only peak height at one wavenumber as identity proof
  • Relying on color change after solvent addition

Correct Answer: Matching sample spectrum to a validated reference spectrum or library with defined acceptance criteria

Q19. What is a critical element of spectral library management for regulated FTIR use?

  • Version control, documented provenance of reference spectra and access controls
  • Allowing unrestricted edits by all users to improve flexibility
  • Storing libraries only on personal USB drives
  • Not documenting changes to expedite analysis

Correct Answer: Version control, documented provenance of reference spectra and access controls

Q20. Which validation characteristic evaluates the method’s ability to remain unaffected by small deliberate changes in parameters?

  • Robustness
  • Sensitivity
  • Specificity
  • Linearity

Correct Answer: Robustness

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