NABL accreditation and Good Laboratory Practices (GLP) are essential for B.Pharm students to understand laboratory quality, compliance, and data integrity. NABL accreditation (ISO/IEC 17025) assesses technical competence, method validation, calibration, traceability, uncertainty, and quality management systems in testing and calibration labs. GLP (OECD principles) ensures reliable non‑clinical safety study conduct through clear roles, SOPs, study plans, documentation, archiving, and QA oversight. Familiarity with SOPs, equipment qualification (IQ/OQ/PQ), proficiency testing, corrective actions, and record keeping builds professional competence and improves pharmaceutical testing reliability. This set of targeted MCQs reinforces concepts in NABL accreditation, GLP, documentation, and method validation. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary international standard that NABL accreditation for testing laboratories is based on?
- OECD GLP Principles
- ISO/IEC 17025
- ISO 9001
- ICH Q7
Correct Answer: ISO/IEC 17025
Q2. Which principle is central to Good Laboratory Practices (GLP)?
- Marketing approval timelines
- Study Director responsibility and documented study plans
- Profit maximization
- Clinical trial design
Correct Answer: Study Director responsibility and documented study plans
Q3. In ISO/IEC 17025, what does “traceability” primarily refer to?
- Chain of custody of samples
- Linking measurements to national or international standards through an unbroken chain
- Traceability of paper documents only
- Tracking employee training records
Correct Answer: Linking measurements to national or international standards through an unbroken chain
Q4. Which document defines the scope of tests for which a laboratory is accredited by NABL?
- Quality manual
- Accreditation certificate scope
- Training matrix
- Nonconformance report
Correct Answer: Accreditation certificate scope
Q5. Which activity is part of method validation commonly emphasized by both NABL and GLP frameworks?
- Marketing validation
- Assessment of accuracy, precision, specificity, linearity, LOD and LOQ
- Only sample storage validation
- Employee satisfaction surveys
Correct Answer: Assessment of accuracy, precision, specificity, linearity, LOD and LOQ
Q6. Under GLP, who is responsible for the overall conduct of a non‑clinical study?
- Quality Assurance Unit
- Study Director
- Laboratory Technician
- Sponsor’s Marketing Manager
Correct Answer: Study Director
Q7. What does IQ/OQ/PQ stand for in equipment qualification?
- Installation, Operational, Performance Qualification
- Initial, Ongoing, Periodic Qualification
- Installation, Optimization, Process Qualification
- Internal, Official, Product Qualification
Correct Answer: Installation, Operational, Performance Qualification
Q8. Which of the following is a key requirement for laboratory personnel under NABL/ISO 17025?
- Only academic degrees matter
- Demonstrated competence and documented training records
- No record of training is needed
- Personnel must be certified pharmacists only
Correct Answer: Demonstrated competence and documented training records
Q9. What is the role of the Quality Assurance Unit (QAU) in GLP laboratories?
- Develop marketing strategies
- Provide independent monitoring and auditing of study conduct and compliance
- Write study reports for sponsors
- Perform all laboratory tests
Correct Answer: Provide independent monitoring and auditing of study conduct and compliance
Q10. Which of the following best describes “measurement uncertainty” required by ISO/IEC 17025?
- An estimate of the doubt about the measurement result expressed quantitatively
- Guarantee that the result is 100% accurate
- Only a qualitative statement about variability
- The number of replicates performed
Correct Answer: An estimate of the doubt about the measurement result expressed quantitatively
Q11. Which practice is mandatory for sample identification and chain of custody in both NABL and GLP contexts?
- Using arbitrary names without documentation
- Unique sample ID, logged transfers, and documented custody
- Storing samples without labels
- Only oral handover of samples
Correct Answer: Unique sample ID, logged transfers, and documented custody
Q12. Which of these is a common nonconformance corrective action in a NABL‑accredited lab?
- Ignore the nonconformance
- Root cause analysis, corrective action, preventive measures, and verification
- Fire the entire staff
- Destroy records to hide the issue
Correct Answer: Root cause analysis, corrective action, preventive measures, and verification
Q13. Proficiency testing or inter‑laboratory comparisons are used to assess what?
- Laboratory marketing reach
- Laboratory performance and comparability of results
- Employee attendance
- Only reagent quality
Correct Answer: Laboratory performance and comparability of results
Q14. What is the primary purpose of Standard Operating Procedures (SOPs) in pharma labs?
- To replace training programs
- To ensure consistent, documented, and reproducible procedures
- To increase paperwork only
- To manage payroll
Correct Answer: To ensure consistent, documented, and reproducible procedures
Q15. Which record‑keeping requirement is emphasized by GLP for study data?
- Destroy raw data after publication
- Maintain complete, legible, and retrievable raw data and final reports for defined retention periods
- Keep only summarized results
- Store data only on personal devices
Correct Answer: Maintain complete, legible, and retrievable raw data and final reports for defined retention periods
Q16. In NABL assessments, what does “scope extension” mean?
- Expanding the laboratory building
- Requesting accreditation for additional tests or fields of testing
- Reducing the accredited tests
- Changing the lab’s director
Correct Answer: Requesting accreditation for additional tests or fields of testing
Q17. Which documentation is essential before starting a GLP study?
- Study plan/protocol with objectives, methods, responsibilities, and schedules
- Only a funding approval letter
- Marketing brochure
- Employee vacation roster
Correct Answer: Study plan/protocol with objectives, methods, responsibilities, and schedules
Q18. What is the significance of calibration in NABL‑accredited laboratories?
- It is optional for most instruments
- Ensures instruments provide accurate results traceable to standards
- Only required for computers
- Replaces method validation
Correct Answer: Ensures instruments provide accurate results traceable to standards
Q19. Under ISO/IEC 17025, which component addresses impartiality and confidentiality?
- Management system and organizational safeguards
- Only technical procedures
- Marketing department duties
- External auditor responsibilities only
Correct Answer: Management system and organizational safeguards
Q20. Which GLP element ensures objective verification that studies comply with GLP?
- Quality Assurance Unit audits and inspections
- Only the Study Director’s opinion
- External advertising
- Unrecorded verbal checks
Correct Answer: Quality Assurance Unit audits and inspections
Q21. What is the role of reference materials in a NABL‑accredited lab?
- For decoration only
- To validate methods, ensure accuracy and provide traceability to SI units or certified values
- Only required for microbiology
- To replace calibrations permanently
Correct Answer: To validate methods, ensure accuracy and provide traceability to SI units or certified values
Q22. Which aspect distinguishes GLP from clinical Good Clinical Practice (GCP)?
- GLP applies to non‑clinical safety studies; GCP applies to human clinical trials
- They are the same standard
- GCP applies to chemical testing only
- GLP governs advertising materials
Correct Answer: GLP applies to non‑clinical safety studies; GCP applies to human clinical trials
Q23. What should a laboratory report include to meet NABL/ISO 17025 requirements?
- Only the final conclusion without methods
- Identification of test, methods used, results, uncertainty, and traceability statements
- Only the signature of the manager
- Only raw chromatograms
Correct Answer: Identification of test, methods used, results, uncertainty, and traceability statements
Q24. Which action is required when a reagent or standard is found to be out of specification in a GLP lab?
- Continue using it without documentation
- Quarantine the reagent, investigate impact on studies, document and take corrective action
- Immediately approve it for sale
- Ignore and destroy the records
Correct Answer: Quarantine the reagent, investigate impact on studies, document and take corrective action
Q25. What is a critical component of stability studies governed by GLP and pharmacopeial guidance?
- Random storage conditions
- Controlled storage conditions, documented sampling schedule, and validated assays
- Only visual inspection
- No documentation needed
Correct Answer: Controlled storage conditions, documented sampling schedule, and validated assays
Q26. For NABL accreditation, how often are surveillance assessments normally conducted?
- Never after initial accreditation
- Periodic assessments, typically every few years or as defined by NABL program
- Daily
- Only when the lab requests
Correct Answer: Periodic assessments, typically every few years or as defined by NABL program
Q27. Which validation parameter assesses the closeness of measured values to the true value?
- Precision
- Accuracy
- Linearity
- Robustness
Correct Answer: Accuracy
Q28. What is the purpose of internal audits in a NABL/GLP compliant laboratory?
- To provide managerial praise only
- To evaluate compliance, detect weaknesses, and drive corrective actions
- To replace external assessments permanently
- To finalize study conclusions
Correct Answer: To evaluate compliance, detect weaknesses, and drive corrective actions
Q29. Which parameter is assessed to demonstrate method precision?
- Limit of detection (LOD)
- Repeatability and intermediate precision expressed as %RSD or SD
- System suitability only
- Storage temperature alone
Correct Answer: Repeatability and intermediate precision expressed as %RSD or SD
Q30. Which record retention practice aligns with GLP principles for archival of study data?
- Short‑term retention until the next study
- Retention for specified periods defined by regulation/sponsor, secure archiving and controlled access
- Retention only on personal laptops
- Immediate disposal after report submission
Correct Answer: Retention for specified periods defined by regulation/sponsor, secure archiving and controlled access
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.
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