Good laboratory practice (GLP) in preclinical studies MCQs With Answer

Introduction: Good Laboratory Practice (GLP) in preclinical studies MCQs With Answer is designed to strengthen M.Pharm students’ understanding of quality systems that ensure reliability and integrity of nonclinical safety and pharmacology data. This set focuses on GLP principles, roles and responsibilities, documentation, study conduct, equipment calibration, test systems, archiving, and regulatory expectations (including OECD principles). The questions include scenarios and focused knowledge checks that mirror real laboratory and regulatory situations encountered during preclinical drug development. Practicing these MCQs will help students internalize GLP concepts essential for designing, executing, auditing, and defending preclinical studies in both industry and regulatory contexts.

Q1. What is the primary objective of Good Laboratory Practice (GLP) in preclinical studies?

• To ensure maximum profit during product development
• To guarantee absolute safety of test articles in humans
• To promote uniformity, consistency, reliability, reproducibility, quality, and integrity of nonclinical safety data
• To replace clinical trials for efficacy assessment

Correct Answer: To promote uniformity, consistency, reliability, reproducibility, quality, and integrity of nonclinical safety data

Q2. Which document outlines the detailed steps and methodology to be used during a GLP study?

• Study Plan (Protocol)
• Standard Operating Procedure (SOP)
• Final Report
• Raw Data Log

Correct Answer: Study Plan (Protocol)

Q3. Which of the following is a core responsibility of the Study Director in a GLP study?

• Preparing the institutional budget for the facility
• Overall scientific and technical conduct of the study and interpretation of results
• Performing routine equipment maintenance
• Archiving all regulatory correspondence

Correct Answer: Overall scientific and technical conduct of the study and interpretation of results

Q4. The Quality Assurance Unit (QAU) in a GLP facility is primarily responsible for:

• Conducting the experimental procedures
• Reviewing and auditing studies to ensure compliance with GLP
• Authorizing funding for studies
• Preparing specimens for histopathology

Correct Answer: Reviewing and auditing studies to ensure compliance with GLP

Q5. Which statement best describes “raw data” under GLP?

• Only final summarized tables and figures
• Any original record or certified copy of observations, measurements, and activities relevant to the study
• Only electronic files generated by instruments
• Only the signed study report

Correct Answer: Any original record or certified copy of observations, measurements, and activities relevant to the study

Q6. Which of the following is NOT an essential element of GLP-compliant documentation?

• Clear identification of personnel who performed and reviewed activities
• Steps to reproduce the exact study conditions
• Undocumented verbal instructions that changed procedures
• Version-controlled SOPs and controlled archiving

Correct Answer: Undocumented verbal instructions that changed procedures

Q7. Under OECD GLP principles, how long should study data and records typically be retained by the test facility?

• Until the study report is drafted, then they can be discarded
• For a reasonable period, normally at least 10 years, or as required by contract or regulation
• Only for one year after study completion
• Only electronic data must be retained, physical records can be destroyed immediately

Correct Answer: For a reasonable period, normally at least 10 years, or as required by contract or regulation

Q8. Which of the following best describes an SOP in a GLP environment?

• An informal guideline for flexible practices
• A detailed, written instruction to achieve uniformity of the performance of a specific function
• A marketing document describing the study
• A confidential email describing daily tasks

Correct Answer: A detailed, written instruction to achieve uniformity of the performance of a specific function

Q9. During a GLP inspection, an inspector asks to see evidence that an analytical instrument was calibrated. Which record is most appropriate to present?

• Purchase invoice for the instrument
• Calibration certificate and calibration log with dates, results, and the person who performed the calibration
• Photograph of the instrument in the lab
• Handwritten note stating the instrument works

Correct Answer: Calibration certificate and calibration log with dates, results, and the person who performed the calibration

Q10. What is the function of archiving in GLP studies?

• To permanently delete redundant data
• To preserve study records and materials so they remain accessible and retrievable for regulatory review and verification
• To store only biological waste
• To store marketing brochures and unrelated documents

Correct Answer: To preserve study records and materials so they remain accessible and retrievable for regulatory review and verification

Q11. In a GLP study involving animals, which documentation is essential to demonstrate ethical and compliant animal use?

• Only the final study report
• Animal care records, ethical approval documents, housing conditions, and treatment records
• Invoices for feed and bedding
• Marketing consent forms from the sponsor

Correct Answer: Animal care records, ethical approval documents, housing conditions, and treatment records

Q12. Which option describes the appropriate action when an unexpected deviation occurs during a GLP study?

• Ignore it if results appear acceptable
• Document the deviation promptly, assess impact, notify Study Director and QAU, and implement corrective actions
• Destroy affected samples to avoid complications
• Wait until the final report to mention it without documentation

Correct Answer: Document the deviation promptly, assess impact, notify Study Director and QAU, and implement corrective actions

Q13. How does GLP differ from GMP and GCP in scope?

• GLP covers clinical trial conduct in humans
• GLP focuses on nonclinical laboratory studies, GMP on manufacturing quality, and GCP on clinical trials with human subjects
• GMP and GLP are identical, GCP is separate
• GCP applies only to veterinary products and GLP to cosmetics

Correct Answer: GLP focuses on nonclinical laboratory studies, GMP on manufacturing quality, and GCP on clinical trials with human subjects

Q14. Which personnel should have direct access to and responsibility for raw data during a GLP study?

• Only the Study Director and the Sponsor
• Personnel who generated the data, their supervisors, and authorized QA reviewers with appropriate documentation
• Any staff in the organization without training
• External marketing team members

Correct Answer: Personnel who generated the data, their supervisors, and authorized QA reviewers with appropriate documentation

Q15. What is the best definition of “test system” in GLP terminology?

• Only the electronic analytical instruments used in the study
• The biological, chemical, or physical system (e.g., animals, cells, microbial cultures) to which the test article is applied
• A computer network used to store data
• The marketing strategy for the product

Correct Answer: The biological, chemical, or physical system (e.g., animals, cells, microbial cultures) to which the test article is applied

Q16. Which practice helps ensure electronic data integrity in a GLP environment?

• Allowing multiple users to share a single login
• Using audit trails, controlled access, validated software, and secure backups
• Permitting ad-hoc edits without records
• Deleting older versions to save space

Correct Answer: Using audit trails, controlled access, validated software, and secure backups

Q17. Which of the following best indicates proper handling of histopathology slides in GLP studies?

• Slides labeled only with date, no other identifiers
• Slides properly labeled with animal/study ID, properly stored, and original slides retained and referenced in reports
• Slides discarded after photomicrographs are taken
• Slides sent home with the histotechnician for safekeeping

Correct Answer: Slides properly labeled with animal/study ID, properly stored, and original slides retained and referenced in reports

Q18. When should deviations from the approved study plan be implemented in a GLP study?

• Whenever convenient without documentation
• Only after formal amendment to the study plan with approval by the Study Director and documented justification
• Immediately upon request by any laboratory staff
• After the study is complete to avoid interruption

Correct Answer: Only after formal amendment to the study plan with approval by the Study Director and documented justification

Q19. Which element is critical in a GLP-compliant chain of custody for samples?

• Unlabeled boxes to protect confidentiality
• Clear labeling, documented transfers, signatures, dates, and storage conditions to maintain traceability
• Only verbal confirmation of receipt between staff
• Storing samples in a single unlocked location

Correct Answer: Clear labeling, documented transfers, signatures, dates, and storage conditions to maintain traceability

Q20. What is the role of external inspection or regulatory audits in GLP?

• To replace the facility’s own QA activities entirely
• To independently verify compliance with GLP principles and identify deficiencies for corrective action
• To certify products for marketing without reviewing data
• To provide informal suggestions with no documentation

Correct Answer: To independently verify compliance with GLP principles and identify deficiencies for corrective action

Download