GLP principles and history in drug development MCQs With Answer

GLP principles and history in drug development MCQs With Answer

Introduction: Good Laboratory Practice (GLP) is a cornerstone of nonclinical safety assessment in drug development. This blog presents targeted multiple-choice questions designed for M.Pharm students to deepen understanding of GLP history, core principles, roles, documentation and regulatory impact. Questions emphasize why GLP emerged, major regulatory frameworks, responsibilities of the study director and quality assurance unit, requirements for facilities, equipment and raw data, and how GLP enables mutual acceptance of nonclinical data across jurisdictions. These MCQs reinforce practical knowledge needed for designing, monitoring and evaluating GLP-compliant toxicology and pharmacology screening studies supporting regulatory submissions.

Q1. What primary event most directly prompted modern GLP regulations in several countries?

• The discovery of thalidomide’s teratogenicity
• The Industrial Bio-Test Laboratories (IBT) fraud and data quality scandals
• The creation of the International Conference on Harmonisation (ICH)
• The first human gene therapy trial

Correct Answer: The Industrial Bio-Test Laboratories (IBT) fraud and data quality scandals

Q2. Which regulatory document is the U.S. FDA regulation that specifically governs GLP for nonclinical laboratory studies?

• 21 CFR Part 11
• 21 CFR Part 210
• 21 CFR Part 58
• ICH E6 (R2)

Correct Answer: 21 CFR Part 58

Q3. The OECD Principles of Good Laboratory Practice are most important because they:

• Establish clinical trial monitoring standards worldwide
• Allow mutual acceptance of nonclinical safety data among participating countries
• Regulate manufacturing quality for active pharmaceutical ingredients
• Detail pharmacokinetic modelling requirements

Correct Answer: Allow mutual acceptance of nonclinical safety data among participating countries

Q4. Which of the following is NOT a core principle of GLP?

• Study plan or protocol
• Quality Assurance (QA) unit independent of study conduct
• Clinical informed consent procedures
• Accurate and complete recording of raw data

Correct Answer: Clinical informed consent procedures

Q5. Who has overall responsibility for the conduct and scientific interpretation of a GLP study?

• Quality Assurance (QA) Unit
• Study Director
• Principal Investigator (for clinical trials)
• Regulatory Affairs Manager

Correct Answer: Study Director

Q6. Which statement best describes the role of the Quality Assurance (QA) unit under GLP?

• QA designs the scientific aspects of the study and interprets data
• QA is independent and monitors compliance with GLP through audits and inspections
• QA manages the daily conduct of the study and supervises technicians
• QA handles regulatory submissions and labeling

Correct Answer: QA is independent and monitors compliance with GLP through audits and inspections

Q7. Which type of studies fall primarily under GLP regulations?

• Phase III clinical trials
• Nonclinical safety studies (toxicology, pharmacology, ADME) used for regulatory submissions
• Commercial manufacturing validation runs
• Bioequivalence studies in healthy volunteers

Correct Answer: Nonclinical safety studies (toxicology, pharmacology, ADME) used for regulatory submissions

Q8. What is considered “raw data” under GLP?

• Only the final study report
• Primary observations and instrument-generated outputs that are the original records of the study
• Promotional materials for the test article
• Only electronic spreadsheets derived from the study

Correct Answer: Primary observations and instrument-generated outputs that are the original records of the study

Q9. Which of the following practices aligns with data integrity expectations such as ALCOA?

• Making handwritten changes without date or signature
• Recording observations contemporaneously with identifiable authorship
• Deleting outdated electronic records without trace
• Using separate undocumented backup copies

Correct Answer: Recording observations contemporaneously with identifiable authorship

Q10. Which of these is the best description of the study plan or protocol under GLP?

• An indeterminate checklist used only by QA
• A pre-defined document describing objectives, methods, test system, schedules and statistical approach
• A marketing brief for the study sponsor
• An internal memo that can be changed without documentation

Correct Answer: A pre-defined document describing objectives, methods, test system, schedules and statistical approach

Q11. Who is typically responsible for long-term archiving of study records in a GLP facility?

• The study director alone
• The test facility with defined archival systems and procedures
• The clinical trial monitor
• The marketing department

Correct Answer: The test facility with defined archival systems and procedures

Q12. Which statement is true about GLP applicability to in vitro studies?

• GLP never applies to in vitro studies
• GLP can apply to in vitro nonclinical studies intended for regulatory submission
• GLP only applies to human clinical cell-based assays
• GLP is only for animal studies and excludes any in vitro testing

Correct Answer: GLP can apply to in vitro nonclinical studies intended for regulatory submission

Q13. Which of the following is a common recommended minimum retention period for GLP study records under many regulations and OECD guidance?

• 6 months
• 2 years
• 10 years
• 50 years

Correct Answer: 10 years

Q14. What is the correct relationship between GLP, GMP and GCP?

• They are identical sets of rules applied interchangeably
• GLP covers nonclinical lab studies, GMP covers manufacturing quality, and GCP covers clinical trials
• GCP is a subset of GLP
• GMP only applies to documentation while GLP applies to ethics

Correct Answer: GLP covers nonclinical lab studies, GMP covers manufacturing quality, and GCP covers clinical trials

Q15. Which element is essential to ensure equipment used in GLP studies is suitable?

• Equipment may be used without calibration if visually clean
• Qualification, calibration, maintenance and written records demonstrating fitness for purpose
• Only equipment purchased from a single supplier is acceptable
• Equipment records can be kept informally without dates

Correct Answer: Qualification, calibration, maintenance and written records demonstrating fitness for purpose

Q16. Under GLP, when should deviations from the study plan be documented?

• Only if the sponsor asks for them
• As soon as they occur, with rationale, authorization and effect on study outcomes
• At the time of report submission, summarized verbally
• Deviations never need formal documentation

Correct Answer: As soon as they occur, with rationale, authorization and effect on study outcomes

Q17. Which of the following best describes the “test article” in GLP terminology?

• The testing facility’s internal SOP index
• The substance or compound being evaluated in the study
• The statistical software used for analysis
• The final marketing sample of a drug product

Correct Answer: The substance or compound being evaluated in the study

Q18. The mutual acceptance of data (MAD) under OECD relies on what condition?

• Only that studies are published in peer-reviewed journals
• That nonclinical studies comply with OECD GLP principles and national regulations
• That studies are conducted in the sponsor’s home country only
• That clinical endpoints are included in nonclinical studies

Correct Answer: That nonclinical studies comply with OECD GLP principles and national regulations

Q19. Which practice demonstrates proper electronic record control under GLP?

• Allowing unrestricted alteration of electronic files with no audit trail
• Implementing secure access controls and audit trails that record changes with user identity and timestamps
• Storing raw data only on personal devices
• Transferring responsibility for records to external consultants with no contracts

Correct Answer: Implementing secure access controls and audit trails that record changes with user identity and timestamps

Q20. Which action is most appropriate if an inspector identifies GLP noncompliance at a facility?

• Immediately ignore the findings and continue studies as usual
• Document corrective and preventive actions (CAPA), implement changes, and notify relevant authorities as required
• Destroy the records associated with the noncompliant study
• Transfer the study to a different sponsor without addressing issues

Correct Answer: Document corrective and preventive actions (CAPA), implement changes, and notify relevant authorities as required

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