Introduction: Good Laboratory Practice (GLP) governs the organization and personnel management essential for reliable nonclinical studies. For B.Pharm students, understanding GLP organization, roles like Study Director and Principal Investigator, Quality Assurance Unit (QAU) functions, SOPs, training, documentation, delegation of authority, equipment calibration, audits, and archiving is vital for regulatory compliance and data integrity. This topic covers personnel qualifications, job descriptions, competency assessment, record-keeping, health and safety, and contractor/vendor oversight to prevent bias and ensure traceability. Mastery of these organizational and personnel principles helps ensure reproducible, auditable preclinical results critical to drug development. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a defined organizational structure under GLP in a test facility?
- To maximize productivity and profits only
- To provide clear responsibility, authority and communication lines for GLP compliance
- To allow informal task assignment without documentation
- To centralize all laboratory work under a single technician
Correct Answer: To provide clear responsibility, authority and communication lines for GLP compliance
Q2. Which statement best describes the role of the Study Director in GLP studies?
- Responsible only for data entry and record keeping
- Single point of responsibility for the overall design, conduct, interpretation and reporting of a GLP study
- Only approves invoices and budgets for the study
- Performs all analytical measurements personally
Correct Answer: Single point of responsibility for the overall design, conduct, interpretation and reporting of a GLP study
Q3. What is the main function of the Quality Assurance Unit (QAU) in a GLP test facility?
- To directly conduct experimental procedures
- To perform independent audits and inspections to ensure GLP compliance
- To manage payroll and human resources
- To market study results to sponsors
Correct Answer: To perform independent audits and inspections to ensure GLP compliance
Q4. In a multi-site GLP study, what is the Principal Investigator’s (PI) primary responsibility?
- To handle all sponsor communications personally
- To be accountable for the conduct of the study at the assigned test facility or portion of the study
- To approve final regulatory submissions
- To audit other test facilities
Correct Answer: To be accountable for the conduct of the study at the assigned test facility or portion of the study
Q5. Why are Standard Operating Procedures (SOPs) critical for personnel under GLP?
- They allow each employee to interpret methods freely
- They provide documented, reproducible instructions ensuring consistent conduct and data integrity
- They replace the need for training
- They are optional guidance documents
Correct Answer: They provide documented, reproducible instructions ensuring consistent conduct and data integrity
Q6. Which elements should a GLP training record minimally contain for each staff member?
- Name, date, training topic, trainer and signature/evidence of competency
- Name and monthly salary only
- Date of hire and resume only
- Only a verbal confirmation without documentation
Correct Answer: Name, date, training topic, trainer and signature/evidence of competency
Q7. What must a GLP job description include to ensure proper personnel qualification and responsibility?
- Only the job title
- Responsibilities, required qualifications, authority and reporting lines
- Personal opinions about the job
- Salary and holiday entitlement only
Correct Answer: Responsibilities, required qualifications, authority and reporting lines
Q8. How should delegation of authority for GLP tasks be documented?
- Orally during meetings with no record
- Through documented, dated delegation records signed by the delegating authority
- By posting a note on the laboratory door
- By assuming delegation without informing QA
Correct Answer: Through documented, dated delegation records signed by the delegating authority
Q9. Why is health surveillance and medical clearance important for GLP personnel working with hazardous test items?
- To create paperwork for the HR department
- To ensure worker safety and suitability for specific laboratory tasks, reducing risk to studies and personnel
- To delay study start dates unnecessarily
- It is optional and rarely beneficial
Correct Answer: To ensure worker safety and suitability for specific laboratory tasks, reducing risk to studies and personnel
Q10. How should conflicts of interest among GLP personnel be managed?
- Ignored because they rarely affect study results
- Identified, recorded and managed or mitigated to protect data integrity and objectivity
- Only disclosed to colleagues verbally
- Handled only after study completion
Correct Answer: Identified, recorded and managed or mitigated to protect data integrity and objectivity
Q11. What characterizes a proper GLP quality assurance inspection?
- Independent, periodic, documented and reporting to management and study records
- Performed only once at facility commissioning
- Done by study staff who performed the work
- Informal discussions with no written follow-up
Correct Answer: Independent, periodic, documented and reporting to management and study records
Q12. Which document outlines the objectives, design, and conduct of a GLP study?
- Study Protocol (or Study Plan)
- Marketing brochure
- Payroll ledger
- Supplier quotation
Correct Answer: Study Protocol (or Study Plan)
Q13. How long should raw data and study records be retained under GLP?
- Until the next lunch break
- As specified by the study plan, sponsor, and applicable regulatory requirements and facility SOPs
- Only while the study is active, then destroyed
- Retention is optional and decided by individual staff
Correct Answer: As specified by the study plan, sponsor, and applicable regulatory requirements and facility SOPs
Q14. Who should approve and control the issuance of SOPs in a GLP facility?
- Any staff member who writes them
- Authorized management with QA review and controlled distribution
- External contractors without oversight
- Only the Study Director at the end of the study
Correct Answer: Authorized management with QA review and controlled distribution
Q15. What is the correct GLP approach when an unexpected deviation occurs during a study?
- Ignore it if results look acceptable
- Document the deviation, investigate cause, evaluate impact on study results and implement corrective actions
- Hide it from the sponsor to avoid delays
- Wait until study end and then decide
Correct Answer: Document the deviation, investigate cause, evaluate impact on study results and implement corrective actions
Q16. What is the recommended frequency of refresher training for GLP personnel?
- Only once at hiring
- Initial training plus periodic refresher training as defined by facility SOPs and job needs
- Daily formal exams for all staff
- Refresher training is unnecessary if staff are experienced
Correct Answer: Initial training plus periodic refresher training as defined by facility SOPs and job needs
Q17. Who is typically responsible for equipment calibration and maintenance in a GLP facility?
- Designated, trained personnel following SOPs or qualified service providers
- Any visitor to the laboratory
- Only the Quality Assurance Unit
- Calibration is unnecessary for GLP equipment
Correct Answer: Designated, trained personnel following SOPs or qualified service providers
Q18. Which items are essential in a personnel file for GLP compliance?
- Training records, qualifications, job description and competency assessments
- Favorite food and music preferences
- Only passport copy
- Only yearly bonus details
Correct Answer: Training records, qualifications, job description and competency assessments
Q19. What does the sponsor of a GLP study typically provide?
- Study objectives, funding, test article information and approval of the final report
- Personal supervision of laboratory technicians daily
- Only catering services for staff
- No responsibilities once the study starts
Correct Answer: Study objectives, funding, test article information and approval of the final report
Q20. How should transfer of study materials between test facilities be documented under GLP?
- Verbal agreement between staff
- Chain-of-custody documentation recording transfers, conditions and responsible personnel
- Only by sending an email without receipt confirmation
- Transfers should not be documented
Correct Answer: Chain-of-custody documentation recording transfers, conditions and responsible personnel
Q21. What facility requirement helps prevent cross-contamination in a GLP laboratory?
- Shared open bench for all hazardous and nonhazardous work
- Separated areas, controlled access, and appropriate containment for different activities
- No requirement for separation as long as staff are careful
- Using the same glassware for all studies without cleaning
Correct Answer: Separated areas, controlled access, and appropriate containment for different activities
Q22. When outsourcing analytical work or services in GLP, what is required?
- No documentation is needed if the vendor is reputable
- A written agreement/contract specifying responsibilities, GLP compliance expectations and data handling
- Only a handshake agreement
- Outsourcing is prohibited under GLP
Correct Answer: A written agreement/contract specifying responsibilities, GLP compliance expectations and data handling
Q23. What is the purpose of change control in a GLP organization?
- To allow undocumented changes at will
- To ensure changes to methods, equipment or SOPs are assessed, approved, documented and communicated
- To prevent any changes forever
- To document only cosmetic changes to office decor
Correct Answer: To ensure changes to methods, equipment or SOPs are assessed, approved, documented and communicated
Q24. When must personnel receive safety and PPE training in a GLP facility?
- Only after an incident occurs
- Before performing tasks involving hazardous materials and periodically thereafter
- Only if requested by the employee
- Training is optional for experienced staff
Correct Answer: Before performing tasks involving hazardous materials and periodically thereafter
Q25. Which of the following best describes “raw data” under GLP?
- Final summary tables only
- Original observations, instrument output (chromatograms, spectra), photographs and electronic files from which results are derived
- Only the study report
- Only emails between staff
Correct Answer: Original observations, instrument output (chromatograms, spectra), photographs and electronic files from which results are derived
Q26. What are key GLP requirements for electronic records and systems?
- No validation is needed for electronic systems
- Systems must be validated, access-controlled, backed up, and maintain an audit trail
- Electronic records can be edited without trace
- Electronic records must be printed and deleted immediately
Correct Answer: Systems must be validated, access-controlled, backed up, and maintain an audit trail
Q27. How should an incident or nonconformance be reported in a GLP setting?
- Reported promptly to the Study Director and QAU, documented and investigated
- Kept confidential among the staff involved only
- Reported months later after conclusions are drawn
- Ignored if it seems minor
Correct Answer: Reported promptly to the Study Director and QAU, documented and investigated
Q28. During a regulatory inspection of a GLP facility, what access must be provided?
- Only a guided tour with selected records
- Full access to facilities, raw data, SOPs and personnel as required by inspectors
- Access only to public areas and marketing materials
- Access can be refused until the end of the inspection
Correct Answer: Full access to facilities, raw data, SOPs and personnel as required by inspectors
Q29. Which methods are effective for assessing personnel competency under GLP?
- Written tests, practical demonstrations, supervised performance and review of records
- Only informal observation without documentation
- Assuming competency based on job title alone
- Competency assessment is not required under GLP
Correct Answer: Written tests, practical demonstrations, supervised performance and review of records
Q30. Who is responsible for approving and signing the final GLP study report?
- The laboratory technician who entered the data
- The Study Director, who is responsible for the overall study and its final report
- The QA inspector only
- The sponsor’s marketing team
Correct Answer: The Study Director, who is responsible for the overall study and its final report
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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