Introduction to Good Laboratory Practice (GLP) MCQs With Answer

Introduction:

This set of MCQs on Introduction to Good Laboratory Practice (GLP) is designed specifically for M.Pharm students preparing for exams and practical QA/QC roles. The questions cover core GLP principles, responsibilities of key personnel, documentation requirements, data integrity, equipment calibration, study conduct, and regulatory expectations (including OECD principles). Emphasis is placed on applied understanding — how GLP controls nonclinical laboratory studies, ensures reliable and reproducible data, and supports regulatory submissions. Use these questions to test conceptual knowledge and decision-making skills relevant to laboratory quality systems and compliance monitoring in pharmaceutical environments.

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

• To ensure the profitability of the laboratory
• To standardize manufacturing processes
• To ensure the quality, integrity and reliability of safety study data
• To replace Good Manufacturing Practice (GMP)

Correct Answer: To ensure the quality, integrity and reliability of safety study data

Q2. Which international document is most commonly referenced for GLP principles governing nonclinical safety studies?

• ICH Q7
• OECD Principles of Good Laboratory Practice
• Pharmacopoeial general chapters
• ISO 9001 Quality Management Standard

Correct Answer: OECD Principles of Good Laboratory Practice

Q3. Who has overall responsibility for the scientific and technical conduct of a GLP study at a test facility?

• Quality Assurance Unit (QAU)
• Sponsor representative
• Laboratory technician
• Study Director

Correct Answer: Study Director

Q4. Which of the following is a key function of the Quality Assurance Unit (QAU) under GLP?

• Designing the study protocol
• Performing routine data analyses for sponsors
• Conducting independent inspections to verify compliance with GLP
• Supervising laboratory personnel

Correct Answer: Conducting independent inspections to verify compliance with GLP

Q5. In GLP, which document details the objectives, design, methods, and acceptance criteria of a study?

• Standard Operating Procedure (SOP)
• Study Plan/Protocol
• Equipment logbook
• Validation report

Correct Answer: Study Plan/Protocol

Q6. Which principle of data integrity (commonly emphasized in GLP and regulatory guidance) requires that original records be attributable, legible, contemporaneous, and accurate?

• GMP
• ALCOA (and ALCOA+)
• CAPA
• ICH Q8

Correct Answer: ALCOA (and ALCOA+)

Q7. Which of the following is an essential requirement for equipment used in GLP studies?

• Any equipment may be used as long as records are kept
• Equipment must be qualified, calibrated, and have maintenance records
• Equipment is only checked once at installation then never again
• Only new equipment is allowed for GLP studies

Correct Answer: Equipment must be qualified, calibrated, and have maintenance records

Q8. A test facility receives an unexpected result. Under GLP, what is the appropriate immediate action?

• Discard the result and repeat the test without documentation
• Perform an undocumented investigation by staff
• Document the deviation, secure raw data, and initiate a formal investigation
• Ignore the result if other results look acceptable

Correct Answer: Document the deviation, secure raw data, and initiate a formal investigation

Q9. Which of the following best describes the GLP requirement for raw data retention?

• Raw data may be discarded after the final report is issued
• Raw data must be retained for a period defined by regulation or sponsor agreement and be fully retrievable
• Only summaries and final reports need to be retained
• Digital data need not be archived if printed copies exist

Correct Answer: Raw data must be retained for a period defined by regulation or sponsor agreement and be fully retrievable

Q10. Who is responsible for ensuring that the sponsor provides the necessary information on the test article to allow proper conduct of a GLP study?

• Study Director
• Quality Assurance Unit
• Sponsor
• Test facility management

Correct Answer: Sponsor

Q11. Which of the following statements correctly distinguishes GLP from GMP?

• GLP applies to production of drugs, GMP applies to laboratory studies
• GLP focuses on nonclinical laboratory study integrity; GMP focuses on manufacturing quality and product safety
• Both are identical and interchangeable
• GMP only applies to medical devices, while GLP only applies to cosmetics

Correct Answer: GLP focuses on nonclinical laboratory study integrity; GMP focuses on manufacturing quality and product safety

Q12. Which item is NOT typically within the scope of GLP regulations?

• Nonclinical safety pharmacology and toxicology studies
• Analytical method validation for manufacturing release testing of marketed products
• Mutagenicity testing using in vitro assays for safety assessment
• Archiving of study records from preclinical studies

Correct Answer: Analytical method validation for manufacturing release testing of marketed products

Q13. For computerized systems used in GLP studies, which activity is considered critical to compliance?

• Installing software without qualification to save time
• Computerized system validation, access controls, and audit trails
• Allowing unrestricted access to all users
• Deleting audit trails after the study to reduce storage

Correct Answer: Computerized system validation, access controls, and audit trails

Q14. Which of the following best describes the role of SOPs in a GLP environment?

• SOPs are optional guides for new staff only
• SOPs are authoritative documents describing standardized methods, responsibilities and procedures to ensure consistency and compliance
• SOPs are only required for quality control analysts
• SOPs should be rewritten for each study to allow flexibility

Correct Answer: SOPs are authoritative documents describing standardized methods, responsibilities and procedures to ensure consistency and compliance

Q15. During an external GLP inspection, the inspector requests access to raw chromatographic data. What is the correct GLP-compliant response?

• Provide only printed summary tables and refuse access to raw files
• Provide full access to original raw data, instrument files, and audit trails as required
• Delete irrelevant data to streamline the inspection
• Offer a verbal summary of results without documentation

Correct Answer: Provide full access to original raw data, instrument files, and audit trails as required

Q16. Which GLP concept ensures that test items, reference standards and samples are uniquely identified and traceable throughout a study?

• Change control
• Chain of custody and labeling procedures
• Method validation
• Personnel training records

Correct Answer: Chain of custody and labeling procedures

Q17. Which of the following is a typical element of a GLP final report?

• Commercial pricing of the test item
• Detailed description of methods, results, deviations, and conclusions
• Only the numerical data without methodology
• Internal staff salaries

Correct Answer: Detailed description of methods, results, deviations, and conclusions

Q18. If an SOP conflict is discovered during a study (two SOPs give different instructions), what is the GLP-compliant course of action?

• Follow the one that seems easier and document nothing
• Pause operations if needed, document the conflict as a deviation, escalate to management, and resolve before critical steps proceed
• Ignore the conflict and continue as normal
• Have staff vote on which SOP to follow

Correct Answer: Pause operations if needed, document the conflict as a deviation, escalate to management, and resolve before critical steps proceed

Q19. Which activity is part of corrective and preventive actions (CAPA) in GLP?

• Documenting a deviation and taking no follow-up action
• Identifying root cause of nonconformance and implementing measures to prevent recurrence
• Blaming individual staff without process evaluation
• Removing audit trails to hide findings

Correct Answer: Identifying root cause of nonconformance and implementing measures to prevent recurrence

Q20. In GLP, what is the significance of archiving study materials, and who usually determines archive retention periods?

• Archiving is optional; the laboratory manager decides retention arbitrarily
• Archiving preserves essential study records for verification; retention periods are typically determined by regulatory requirements and sponsor agreements
• Archiving is primarily for marketing materials and determined by sales
• Archiving involves deleting electronic data after five years to save space

Correct Answer: Archiving preserves essential study records for verification; retention periods are typically determined by regulatory requirements and sponsor agreements

Download