Scope and definitions under GLP MCQs With Answer

Scope and definitions under GLP MCQs With Answer

This set of multiple-choice questions focuses on the scope and core definitions within Good Laboratory Practice (GLP), tailored for M.Pharm students preparing for advanced QA/QC roles. The quiz emphasizes non-clinical study conduct, key GLP concepts (test article, test system, study director, sponsor, QA unit), documentation practices, data integrity, facility and archiving requirements, and regulatory expectations under OECD and national frameworks. Each question is designed to deepen understanding of practical GLP application in laboratory settings, encourage accurate interpretation of regulations and help prepare students for inspections, audits, and real-world study management.

Q1. Which area best falls within the scope of Good Laboratory Practice (GLP)?

• Clinical trials in human subjects
• Non-clinical health and environmental safety studies
• Routine manufacturing quality control testing
• Marketing and pharmacovigilance activities

Correct Answer: Non-clinical health and environmental safety studies

Q2. Which international organisation developed the widely recognised Principles of GLP used by many countries?

• World Health Organisation (WHO)
• International Council for Harmonisation (ICH)
• Organisation for Economic Co-operation and Development (OECD)
• Food and Drug Administration (FDA)

Correct Answer: Organisation for Economic Co-operation and Development (OECD)

Q3. How is the term “test article” defined under GLP?

• The laboratory equipment used for analyses
• The substance, mixture or article being tested in a study
• The control sample used for calibration
• Any reagent used during an assay

Correct Answer: The substance, mixture or article being tested in a study

Q4. Which description best matches a “test system” in GLP studies?

• The standard operating procedures governing the study
• The personnel team conducting the study
• Animals, plants, microorganisms, tissues, or in vitro systems used in the study
• The electronic data management software

Correct Answer: Animals, plants, microorganisms, tissues, or in vitro systems used in the study

Q5. What is the primary responsibility of the Study Director in a GLP study?

• Managing financial aspects of the laboratory
• Performing all laboratory analyses personally
• Overall scientific conduct and interpretation of the study
• Maintaining the facility equipment

Correct Answer: Overall scientific conduct and interpretation of the study

Q6. Which function is characteristic of the Quality Assurance (QA) Unit under GLP?

• Performing the primary experimental procedures for the study
• Providing independent monitoring, audits and documentation of compliance
• Authorising marketing applications for new drugs
• Developing the test article formulation

Correct Answer: Providing independent monitoring, audits and documentation of compliance

Q7. In GLP, “raw data” is best described as which of the following?

• Summarised tables in the final report
• Original observations and recordings from which study results are derived
• Copies of the final study report for reviewers
• Electronic backups stored off-site only

Correct Answer: Original observations and recordings from which study results are derived

Q8. What is the purpose of a “master schedule” in a GLP test facility?

• To list only the names of laboratory staff
• To track all ongoing and planned GLP studies, timelines and responsible personnel
• To record financial expenditures for each study
• To list equipment maintenance logs only

Correct Answer: To track all ongoing and planned GLP studies, timelines and responsible personnel

Q9. A common minimum recommendation for GLP record retention after study completion is:

• 1 year
• At least 10 years after study completion (or longer per national regulations)
• 6 months
• 50 years

Correct Answer: At least 10 years after study completion (or longer per national regulations)

Q10. In GLP practice, “archiving” refers to:

• The routine disposal of obsolete reagents
• Long-term storage and protection of final study records, raw data and specimens
• The daily lab bench tidying procedure
• Short-term storage of samples for immediate analysis

Correct Answer: Long-term storage and protection of final study records, raw data and specimens

Q11. What is a “control article” in GLP terminology?

• An article used to identify study personnel
• A substance used as a reference or comparator (positive/negative) in a study
• The form used to report deviations
• An electronic device for data capture

Correct Answer: A substance used as a reference or comparator (positive/negative) in a study

Q12. Why are Standard Operating Procedures (SOPs) essential under GLP?

• They are optional guidelines with no regulatory importance
• They document the written, approved methods to ensure consistency and reproducibility of study activities
• They only contain safety instructions for visitors
• They are marketing documents used to promote laboratory services

Correct Answer: They document the written, approved methods to ensure consistency and reproducibility of study activities

Q13. In the context of data integrity under GLP, ALCOA stands for which set of principles?

• Available, Linked, Complete, Original, Accurate
• Attributable, Legible, Contemporaneous, Original, Accurate
• Archived, Logged, Confidential, Organized, Auditable
• Analysed, Labelled, Controlled, Observed, Assured

Correct Answer: Attributable, Legible, Contemporaneous, Original, Accurate

Q14. Are GLP principles directly applicable to clinical trials in human subjects?

• Yes, GLP fully replaces GCP for clinical trials
• No, GLP applies mainly to non-clinical laboratory studies while Good Clinical Practice (GCP) governs clinical trials
• Only if the clinical trial uses animals
• Only for pharmacokinetic endpoints

Correct Answer: No, GLP applies mainly to non-clinical laboratory studies while Good Clinical Practice (GCP) governs clinical trials

Q15. What is a primary responsibility of the study Sponsor under GLP?

• Conducting all laboratory assays personally
• Commissioning, financing the study and providing necessary information and resources to ensure compliance
• Maintaining the freezer temperatures
• Writing SOPs for the QA Unit

Correct Answer: Commissioning, financing the study and providing necessary information and resources to ensure compliance

Q16. How does an internal QA audit differ from a regulatory inspection?

• An internal QA audit is carried out by external authorities; an inspection is internal
• An internal QA audit is voluntary and internal; an inspection is conducted by a regulatory authority with legal powers
• There is no difference; both are identical processes
• An internal QA audit always results in facility closure

Correct Answer: An internal QA audit is voluntary and internal; an inspection is conducted by a regulatory authority with legal powers

Q17. The primary purpose of maintaining chain of custody for samples in GLP studies is to:

• Minimise the cost of sample storage
• Ensure traceability, integrity and accountability of samples from collection to final disposition
• Limit access to laboratory personnel only
• Guarantee immediate disposal after analysis

Correct Answer: Ensure traceability, integrity and accountability of samples from collection to final disposition

Q18. What is required for computerised systems used to capture and store GLP data?

• No validation required if the system is commercially available
• Validation to demonstrate suitability for intended use and appropriate controls to ensure data integrity
• Only password protection is sufficient
• Systems must be replaced annually

Correct Answer: Validation to demonstrate suitability for intended use and appropriate controls to ensure data integrity

Q19. Which facility design feature is important to maintain GLP compliance and prevent cross-contamination?

• Open-plan areas mixing test systems and storage
• Separate, clearly demarcated areas for handling test articles, animals, analytical labs and archives
• Shared ventilation with manufacturing areas
• No designated storage for hazardous materials

Correct Answer: Separate, clearly demarcated areas for handling test articles, animals, analytical labs and archives

Q20. When is a deviation from an approved study plan or SOP acceptable under GLP?

• Never acceptable under any circumstances
• Only if the deviation is documented, justified, investigated and approved by the Study Director or QA according to procedure
• Whenever personnel decide informally
• Only after the final report is submitted

Correct Answer: Only if the deviation is documented, justified, investigated and approved by the Study Director or QA according to procedure

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