Government drug analysts – roles and responsibilities MCQs With Answer

Introduction

Government drug analysts play a vital role in public health and law enforcement by performing forensic analysis, drug testing, and quality control of pharmaceuticals and seized substances. Their roles and responsibilities include sample collection, maintaining chain of custody, method validation, instrument operation (HPLC, GC-MS, LC-MS, FTIR), adherence to pharmacopoeial standards, documentation under GLP and ISO/IEC 17025, and courtroom testimony. B.Pharm students should understand analytical techniques, impurity profiling, stability testing, reference standards, and regulatory compliance to support accurate identification, quantification, and legal defensibility of results. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of maintaining chain of custody for drug samples?

• To prevent laboratory equipment theft
• To document the chronological control and handling of evidence
• To ensure rapid disposal of samples
• To increase the sample volume for analysis

Correct Answer: To document the chronological control and handling of evidence

Q2. Which instrument is most commonly used for confirmatory identification of organic drugs in forensic labs?

• UV-Visible spectrophotometer
• Gas chromatography–mass spectrometry (GC-MS)
• pH meter
• Polarimeter

Correct Answer: Gas chromatography–mass spectrometry (GC-MS)

Q3. In method validation, which parameter assesses closeness between measured value and true value?

• Precision
• Accuracy
• Specificity
• Robustness

Correct Answer: Accuracy

Q4. Which guideline or accreditation is most relevant for a government forensic drug laboratory’s quality system?

• ICH Q7
• ISO/IEC 17025
• FDA 21 CFR Part 11 only
• USP General Notices

Correct Answer: ISO/IEC 17025

Q5. Which test is typically used as a rapid presumptive field test for suspected opioids?

• Milleri test
• Duquenois-Levine test
• Marquis reagent test
• Karl Fischer titration

Correct Answer: Marquis reagent test

Q6. Which pharmacopoeial concept ensures consistency and traceability of chemical measurements?

• Reference standards
• Label claims
• Packaging design
• Preservative selection

Correct Answer: Reference standards

Q7. What is the main responsibility of a government drug analyst when test results contradict an earlier report?

• Discard the sample to avoid controversy
• Perform investigation, document discrepancies, and if needed, re-analyze with documented rationale
• Change the report to match the earlier one
• Send the sample to the press

Correct Answer: Perform investigation, document discrepancies, and if needed, re-analyze with documented rationale

Q8. Which parameter indicates the lowest concentration that can be reliably quantified by an analytical method?

• LOD (Limit of Detection)
• System Suitability
• LOQ (Limit of Quantitation)
• Specificity

Correct Answer: LOQ (Limit of Quantitation)

Q9. During GC-MS analysis of seized heroin, which ion provides the most reliable structural information?

• Base peak and fragmentation ions in the mass spectrum
• Retention time only
• pH of the injection solvent
• Sample color

Correct Answer: Base peak and fragmentation ions in the mass spectrum

Q10. What is an essential element of documentation in a government drug analyst’s report?

• Assumed identity without supporting data
• Complete description of methods, results, uncertainties, and signature of analyst
• Only chromatograms without interpretation
• References to unpublished notes only

Correct Answer: Complete description of methods, results, uncertainties, and signature of analyst

Q11. Which activity is a regulatory responsibility of a government drug analyst related to pharmaceuticals?

• Advertising new drugs
• Quality control testing for compliance with pharmacopoeial monographs
• Formulating new dosage forms
• Designing marketing strategies

Correct Answer: Quality control testing for compliance with pharmacopoeial monographs

Q12. What is the significance of system suitability tests before sample analysis by HPLC?

• They are optional and rarely used
• They verify the chromatographic system performs adequately for intended analysis
• They replace calibration
• They determine the sample pH

Correct Answer: They verify the chromatographic system performs adequately for intended analysis

Q13. Which documentation ensures sample identity, custody, and transfer details?

• Material Safety Data Sheet (MSDS)
• Chain-of-custody form
• Purchase order
• Calibration certificate

Correct Answer: Chain-of-custody form

Q14. For seized tablets suspected to contain a new psychoactive substance (NPS), what is a critical analyst task?

• Assume the substance is safe
• Perform broad-screening (GC-MS/LC-MS) and compare to spectral libraries and reference standards
• Only weigh the tablets
• Ship them without analysis

Correct Answer: Perform broad-screening (GC-MS/LC-MS) and compare to spectral libraries and reference standards

Q15. Which ethical responsibility applies when an analyst faces pressure to alter results?

• Yield to pressure to expedite cases
• Maintain impartiality and report results truthfully with documentation
• Hide uncertain results
• Only report favorable outcomes

Correct Answer: Maintain impartiality and report results truthfully with documentation

Q16. What is the role of proficiency testing in a government drug laboratory?

• To train administrative staff
• To assess and demonstrate analytical competence and inter-laboratory performance
• To calibrate balances
• To increase sample throughput

Correct Answer: To assess and demonstrate analytical competence and inter-laboratory performance

Q17. Which practice helps prevent cross-contamination during sample handling?

• Reusing disposable spatulas
• Using dedicated or properly cleaned glassware, PPE, and workspaces
• Mixing multiple samples in one vial
• Storing all samples together without labels

Correct Answer: Using dedicated or properly cleaned glassware, PPE, and workspaces

Q18. Which documentation is required when an analyst calibrates an analytical balance?

• Only verbal confirmation
• Calibration record including date, standard masses used, results, and analyst signature
• No documentation is necessary
• Email to colleagues

Correct Answer: Calibration record including date, standard masses used, results, and analyst signature

Q19. What distinguishes a confirmatory test from a presumptive test?

• Confirmatory tests are faster
• Confirmatory tests provide specific molecular identification with high reliability, while presumptive tests are screening and less specific
• Presumptive tests quantify impurities
• There is no difference

Correct Answer: Confirmatory tests provide specific molecular identification with high reliability, while presumptive tests are screening and less specific

Q20. When preparing a forensic report, how should uncertainty be handled?

• Ignored to simplify the report
• Quantified where possible and clearly stated to reflect confidence in measurements
• Expressed as absolute zero
• Replaced by educated guesses

Correct Answer: Quantified where possible and clearly stated to reflect confidence in measurements

Q21. Which parameter in dissolution testing is directly relevant to assessing oral dosage form performance?

• Melting point
• Dissolution rate and percent dissolved over time
• Optical rotation
• Particle color

Correct Answer: Dissolution rate and percent dissolved over time

Q22. Which record must be preserved to support chain-of-custody and legal admissibility?

• Laboratory lunch menus
• All original sample receipt forms, custody logs, and transfer records
• Only final report summary without raw data
• Personal notes not signed

Correct Answer: All original sample receipt forms, custody logs, and transfer records

Q23. How is sample stability best managed in a government drug testing context?

• Store all samples at room temperature indefinitely
• Follow validated storage conditions, document storage time/temperature, and use preservatives when validated
• Expose samples to sunlight to ensure dryness
• Label samples without date

Correct Answer: Follow validated storage conditions, document storage time/temperature, and use preservatives when validated

Q24. Which analytical approach is most appropriate for quantifying low-level impurities in a drug substance?

• Thin-layer chromatography without standards
• High-sensitivity LC-MS/MS with validated method
• Visual inspection
• Heating the sample

Correct Answer: High-sensitivity LC-MS/MS with validated method

Q25. What is an analyst’s duty when handling controlled substances under law?

• Divulge chain-of-custody to unauthorized persons
• Comply with legal storage, documentation, inventory, and disposal regulations
• Ignore legal classifications
• Store samples in personal lockers

Correct Answer: Comply with legal storage, documentation, inventory, and disposal regulations

Q26. Which metric evaluates method precision?

• System suitability only
• Relative standard deviation (RSD) of replicate measurements
• pH value
• Retention time alone

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

Q27. How should an analyst respond if a sample label is damaged and identity is unclear?

• Proceed without correcting the label
• Quarantine sample, attempt to reconstruct chain-of-custody, document issue, and notify supervisor before analysis
• Discard the sample immediately
• Relabel arbitrarily

Correct Answer: Quarantine sample, attempt to reconstruct chain-of-custody, document issue, and notify supervisor before analysis

Q28. In courtroom testimony, what is a critical competency for a government drug analyst?

• Ability to speculate outcomes
• Clear, unbiased explanation of methods, findings, limitations, and expert opinion based on evidence
• Use of technical jargon without explanation
• Refusal to answer procedural questions

Correct Answer: Clear, unbiased explanation of methods, findings, limitations, and expert opinion based on evidence

Q29. Which safety practice is essential when handling unknown powdery drug samples?

• No PPE is required
• Use appropriate PPE (gloves, mask/respirator, eye protection) and work in containment or fume hood as necessary
• Smell the powder to identify it
• Open samples in crowded areas

Correct Answer: Use appropriate PPE (gloves, mask/respirator, eye protection) and work in containment or fume hood as necessary

Q30. Which activity supports continuous improvement in a government forensic drug laboratory?

• Ignoring audit findings
• Regular internal audits, root cause analysis, corrective actions, and staff training
• Restricting staff access to training
• Refusing to update methods

Correct Answer: Regular internal audits, root cause analysis, corrective actions, and staff 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