Analytical method transfer and quality control requirements MCQs With Answer

Analytical method transfer and quality control requirements MCQs With Answer
Analytical method transfer is the planned process of moving a validated analytical procedure between laboratories, instruments, or organizations while ensuring method performance is maintained. Quality control requirements focus on verification, system suitability, documentation, acceptance criteria, and compliance with regulatory guidance such as ICH Q2(R1) and GMP. B. Pharm students should understand method validation parameters (accuracy, precision, specificity, LOD/LOQ, linearity, robustness), risk assessment, transfer protocols, and troubleshooting strategies. This set of MCQs reinforces practical and theoretical aspects of method transfer and QC to prepare you for lab work and regulatory inspections. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of analytical method transfer?

• To change the chemical structure of the drug
• To ensure the method performs equivalently at the receiving site
• To reduce the cost of analysis by using cheaper reagents
• To replace stability studies

Correct Answer: To ensure the method performs equivalently at the receiving site

Q2. Which ICH guideline is most relevant for analytical method validation parameters used during transfer?

• ICH Q9
• ICH Q2(R1)
• ICH Q3A
• ICH Q7

Correct Answer: ICH Q2(R1)

Q3. During method transfer, what is verification?

• Full revalidation of the method from scratch
• Confirming that the method performs as expected in the receiving lab under defined conditions
• Changing method parameters to fit local instruments
• Only transferring SOP documents without testing

Correct Answer: Confirming that the method performs as expected in the receiving lab under defined conditions

Q4. Which parameter assesses closeness of measured values to the true value?

• Precision
• Specificity
• Accuracy
• Robustness

Correct Answer: Accuracy

Q5. System suitability tests are performed to evaluate which of the following?

• The chemical stability of the analyte only
• Whether the analytical system is functioning properly before sample analysis
• Stability indicating capability over long-term storage
• Regulatory authority performance

Correct Answer: Whether the analytical system is functioning properly before sample analysis

Q6. Which statistical tool is commonly used to compare means between two laboratories in transfer studies?

• Chi-square test
• Student’s t-test
• Kruskal-Wallis test
• Pearson correlation coefficient

Correct Answer: Student’s t-test

Q7. What does LOD stand for and indicate?

• Limit of Detection; lowest analyte amount that can be detected but not necessarily quantified
• Limit of Degradation; point where analyte degrades
• Length of Dilution; dilution factor for standards
• Level of Documentation; required SOP completeness

Correct Answer: Limit of Detection; lowest analyte amount that can be detected but not necessarily quantified

Q8. Which acceptance criterion is commonly used for precision in method transfer?

• RSD should be less than a predefined value (e.g., ≤2% or as per method)
• Mean must equal zero
• Peak symmetry must be greater than 5
• LOD must be identical between labs

Correct Answer: RSD should be less than a predefined value (e.g., ≤2% or as per method)

Q9. What is robustness testing intended to evaluate?

• Effect of small deliberate variations in method parameters on performance
• Effect of long-term storage on sample stability
• Purity of starting materials
• Interchangeability of solvents based on cost

Correct Answer: Effect of small deliberate variations in method parameters on performance

Q10. In chromatographic methods, which metric assesses column efficiency?

• Tailing factor
• Theoretical plates (N)
• Retention time only
• System suitability limit

Correct Answer: Theoretical plates (N)

Q11. What is a transfer protocol?

• An informal email describing method changes
• A formal document outlining objectives, experiments, acceptance criteria, and responsibilities for method transfer
• A list of vendors for instruments
• Marketing material for the analytical method

Correct Answer: A formal document outlining objectives, experiments, acceptance criteria, and responsibilities for method transfer

Q12. Which of the following best describes specificity?

• Ability to repeat results under same conditions
• Ability to assess stability of excipients
• Ability to measure the analyte unequivocally in the presence of components like impurities and matrix
• Ability to detect very low concentrations

Correct Answer: Ability to measure the analyte unequivocally in the presence of components like impurities and matrix

Q13. When transferring a stability-indicating HPLC method, which experiment is essential?

• Forced degradation to ensure degradation peaks are resolved
• Microbiological assay
• Only system calibration
• Raw material supplier audit

Correct Answer: Forced degradation to ensure degradation peaks are resolved

Q14. Which document should the receiving lab produce after successful transfer verification?

• Transfer rejection note
• Method transfer report summarizing data and conclusions
• Invoice for instrument usage
• Uncontrolled working draft

Correct Answer: Method transfer report summarizing data and conclusions

Q15. In method transfer, what does “inter-laboratory variability” refer to?

• Variability observed in replicate injections within the same run
• Differences in method performance outcomes between different laboratories
• Differences between analyst handwriting
• Supply chain delays for reagents

Correct Answer: Differences in method performance outcomes between different laboratories

Q16. Which parameter defines the concentration range where the method is accurate and precise?

• Specificity
• Range
• Resolution
• Retention factor

Correct Answer: Range

Q17. Which phase of equipment qualification ensures operation under simulated normal conditions?

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

Correct Answer: PQ (Performance Qualification)

Q18. What is the role of system suitability criteria in method transfer?

• They are optional guidelines with no impact
• They define pre-analysis checks to confirm system readiness and comparability between labs
• They replace method validation studies
• They ensure the reagents are cheapest available

Correct Answer: They define pre-analysis checks to confirm system readiness and comparability between labs

Q19. Which term describes meeting regulatory expectations without full revalidation when transferring a method between similar equipment under same ownership?

• Method obsolescence
• Method verification or limited revalidation
• Method redundancy
• Method simplification

Correct Answer: Method verification or limited revalidation

Q20. For impurity methods, why is resolution important during transfer?

• Resolution determines the cost of solvents
• To ensure impurities are adequately separated from the main peak for accurate quantification
• Resolution only affects column lifetime
• It is only relevant for microbiological assays

Correct Answer: To ensure impurities are adequately separated from the main peak for accurate quantification

Q21. Which acceptance criteria might be used to demonstrate equivalence of assay results between transferring and receiving labs?

• Results must be identical to six decimal places
• Results fall within predefined recovery range (e.g., 98–102%) or meet statistical equivalence limits
• Receiving lab results must be higher than transferring lab
• No criteria are needed if SOPs are copied

Correct Answer: Results fall within predefined recovery range (e.g., 98–102%) or meet statistical equivalence limits

Q22. What is a common cause of failed method transfer?

• Proper training of personnel
• Instrument differences and unoptimized method parameters
• Well-documented SOPs
• Use of identical reagents

Correct Answer: Instrument differences and unoptimized method parameters

Q23. Which parameter is evaluated to assess peak shape quality in chromatography?

• LOD and LOQ
• Tailing factor and symmetry
• Buffer pH only
• System pressure only

Correct Answer: Tailing factor and symmetry

Q24. What is the importance of matrix effects in method transfer for biological or complex dosage forms?

• Matrix effects are irrelevant for transfers
• Matrix can suppress or enhance analyte signal, affecting accuracy and requiring evaluation
• Matrix only affects color of solution
• Matrix ensures better chromatography automatically

Correct Answer: Matrix can suppress or enhance analyte signal, affecting accuracy and requiring evaluation

Q25. During transfer, which calibration-related parameter should be comparable between labs?

• Number of analysts only
• Calibration curve linearity, slope, and correlation coefficient within acceptance
• Manufacturer of glassware
• Batch number of the mobile phase solvent

Correct Answer: Calibration curve linearity, slope, and correlation coefficient within acceptance

Q26. What does method ruggedness evaluate?

• Effect of deliberate small changes like analyst, equipment, or reagent lots on method performance
• Only long-term stability of samples
• Only the pH of mobile phase
• Cost-effectiveness of the method

Correct Answer: Effect of deliberate small changes like analyst, equipment, or reagent lots on method performance

Q27. Why is documentation crucial in method transfer?

• To satisfy auditors, provide traceability, and support conclusions on transfer success or failure
• Documentation is optional in regulated labs
• It replaces the need for experimental data
• It is used only for marketing

Correct Answer: To satisfy auditors, provide traceability, and support conclusions on transfer success or failure

Q28. Which of the following is a typical element of a method transfer report?

• List of HR policies
• Experimental data, statistical analysis, conclusions, and deviations
• Only the invoice for training
• Non-scientific opinions about the method

Correct Answer: Experimental data, statistical analysis, conclusions, and deviations

Q29. How is LOQ different from LOD?

• LOQ is the limit of quantitation, the lowest amount that can be quantified with acceptable precision and accuracy; LOD is detection only
• LOD is always higher than LOQ
• LOQ measures peak symmetry and LOD measures calibration slope
• There is no difference; they are synonyms

Correct Answer: LOQ is the limit of quantitation, the lowest amount that can be quantified with acceptable precision and accuracy; LOD is detection only

Q30. What is the best initial step when a transferred method fails at the receiving lab?

• Discard the method immediately
• Perform a root cause investigation including review of SOPs, reagents, instruments, and analyst training
• Request refunds from the transferring lab
• Ignore the failure and proceed with analysis

Correct Answer: Perform a root cause investigation including review of SOPs, reagents, instruments, and analyst training

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com