USFDA GLP regulations (Subpart A–K) MCQs With Answer

Introduction: This quiz collection on USFDA GLP regulations (Subpart A–K) is designed specifically for M.Pharm students preparing for exams and regulatory practice. It focuses on the core principles, roles, facility and equipment requirements, study conduct, documentation, quality assurance, and reporting obligations under 21 CFR Part 58. Each question emphasizes practical application and deeper understanding of GLP expectations in nonclinical laboratory studies—such as responsibilities of the study director and QA unit, test article handling, SOPs, data integrity, and audit/inspection readiness. Use these MCQs to test knowledge, identify gaps, and reinforce correct regulatory behavior essential for compliance and study reliability.

Q1. Which of the following best describes the primary purpose of USFDA GLP regulations?

• To regulate human clinical trial consent procedures
• To ensure integrity and reliability of nonclinical laboratory study data
• To set pricing standards for pharmaceutical products
• To replace Good Manufacturing Practice (GMP) requirements

Correct Answer: To ensure integrity and reliability of nonclinical laboratory study data

Q2. Who has the overall responsibility for the scientific conduct and interpretation of a GLP study?

• The Quality Assurance Unit
• The Sponsor’s Regulatory Affairs Manager
• The Study Director
• The Laboratory Technician

Correct Answer: The Study Director

Q3. What is the essential characteristic of the Quality Assurance Unit (QAU) under GLP?

• It reports functionally to the Study Director
• It must be independent of study conduct and participate in study duties
• It must be independent of study conduct and have direct access to study records
• It is responsible for statistical analysis of study data

Correct Answer: It must be independent of study conduct and have direct access to study records

Q4. Which item is NOT typically required to be included in a written protocol for a nonclinical GLP study?

• Identification of test and control articles and their formulations
• Subjective opinions of the Study Director about expected market success
• Detailed study design, including phases, sampling, and analytical methods
• Criteria for data collection, handling and reporting

Correct Answer: Subjective opinions of the Study Director about expected market success

Q5. Under GLP, which statement about standard operating procedures (SOPs) is correct?

• SOPs are optional and only required for large testing facilities
• SOPs must be written, dated, available to personnel and followed consistently
• SOPs need only be verbal instructions documented in meeting minutes
• SOPs should be revised yearly regardless of relevance

Correct Answer: SOPs must be written, dated, available to personnel and followed consistently

Q6. What is the primary GLP expectation regarding laboratory equipment used in a study?

• Equipment must be brand new for each study
• Equipment must be suitable, calibrated, maintained, and records retained
• Equipment maintenance can be documented only verbally
• Only visual inspection is necessary to qualify equipment

Correct Answer: Equipment must be suitable, calibrated, maintained, and records retained

Q7. Which of the following best describes GLP requirements for test and control articles?

• They must be anonymous with no labelling to prevent bias
• They must be characterized, appropriately labeled, stored, and traceable
• Only the sponsor needs to keep information about composition and handling
• Control articles need not be documented if widely used

Correct Answer: They must be characterized, appropriately labeled, stored, and traceable

Q8. What is the correct GLP approach when a testing facility subcontracts a portion of a study to another lab?

• The subcontractor assumes full responsibility and the original testing facility is no longer liable
• The testing facility must ensure the subcontractor follows GLP and retains oversight and records access
• The sponsor must directly manage the subcontractor without testing facility involvement
• No documentation is required for subcontracting under GLP

Correct Answer: The testing facility must ensure the subcontractor follows GLP and retains oversight and records access

Q9. Which of these is considered raw data under GLP?

• Final summarized tables only
• Original laboratory notebooks, instrument printouts, and photographic images
• Draft versions of the final report only
• Marketing materials derived from the study

Correct Answer: Original laboratory notebooks, instrument printouts, and photographic images

Q10. GLP requires documentation of deviations from the protocol. Which action best aligns with GLP expectations when a deviation occurs?

• Ignore minor deviations and not record them to save time
• Document each deviation, evaluate its impact, and implement corrective actions
• Only notify the sponsor at the end of the study without further analysis
• Destroy records of deviations that do not alter study outcome

Correct Answer: Document each deviation, evaluate its impact, and implement corrective actions

Q11. Which of the following elements should be included in a GLP final study report?

• Study identification, methods, results, discussion, and conclusions
• Only raw data without any interpretation or summary
• Commercial plans for product launch
• Personal opinions of staff unrelated to study results

Correct Answer: Study identification, methods, results, discussion, and conclusions

Q12. Regarding personnel under GLP, which statement is correct?

• Only the Study Director needs documented training
• All personnel must have defined responsibilities, qualifications, and training records
• Training records are not required if personnel are experienced
• Outsourced staff do not need to follow facility training requirements

Correct Answer: All personnel must have defined responsibilities, qualifications, and training records

Q13. What is a key GLP expectation for facility design and operation?

• Facilities may be shared between incompatible studies without segregation
• Facilities must prevent cross-contamination, permit cleanliness, and support the welfare of test systems
• Facility layout is unimportant as long as data is backed up electronically
• Animal housing and analytical labs can be combined without separation

Correct Answer: Facilities must prevent cross-contamination, permit cleanliness, and support the welfare of test systems

Q14. Under GLP, what is the correct handling of electronic records and systems used to generate study data?

• Electronic systems must be validated, protected, and include mechanisms to ensure data integrity
• Electronic records can be modified freely without audit trails
• No validation is needed if the system is commercially available
• Paper records exclusively must be used; electronic records are prohibited

Correct Answer: Electronic systems must be validated, protected, and include mechanisms to ensure data integrity

Q15. Which party should be notified if significant noncompliance or conditions that affect study integrity are discovered during a study?

• Only the laboratory janitorial staff
• The Study Director and Sponsor (and other responsible parties) so corrective actions can be taken
• Competitors to assess market impact
• No one—issues should be resolved internally without notification

Correct Answer: The Study Director and Sponsor (and other responsible parties) so corrective actions can be taken

Q16. What is the role of control articles in GLP studies?

• To serve as comparative materials that help interpret test article effects
• To obscure the identity of the test article so staff cannot analyze it
• To replace test articles when they are lost
• To serve as decorative items in the laboratory

Correct Answer: To serve as comparative materials that help interpret test article effects

Q17. Which of the following best describes GLP expectations for storage and archiving of study records and materials?

• Records and specimens should be stored in a secure, retrievable fashion for a defined period and protected against loss or deterioration
• Records may be discarded immediately after the final report is signed
• Only digital backups are required; originals can be discarded
• Archiving is optional and decided by the laboratory manager

Correct Answer: Records and specimens should be stored in a secure, retrievable fashion for a defined period and protected against loss or deterioration

Q18. During a GLP inspection, what access must be provided to FDA inspectors?

• Inspectors should only be shown summary reports and not raw data
• Inspectors must be given access to records, facilities, and personnel relevant to the study under inspection
• Inspectors may only view records after a 30-day notice period
• Inspectors are not allowed in animal housing areas under any circumstances

Correct Answer: Inspectors must be given access to records, facilities, and personnel relevant to the study under inspection

Q19. Which action best ensures traceability of a test article throughout a GLP study?

• Labeling containers with unique identifiers and maintaining chain-of-custody records
• Using handwritten, unreadable labels to protect confidentiality
• Mixing test articles together to simplify storage
• Relying on staff memory to recall which container holds which article

Correct Answer: Labeling containers with unique identifiers and maintaining chain-of-custody records

Q20. What is the primary function of the Study Director when interacting with the Quality Assurance Unit?

• To produce QA audit reports on behalf of the QAU
• To ensure the study is conducted according to the protocol and provide required access and information to the QAU
• To perform routine maintenance tasks for the QAU
• To interfere with QAU independence by directing their daily activities

Correct Answer: To ensure the study is conducted according to the protocol and provide required access and information to the QAU

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