Quality Assurance Unit and responsibilities under GLP MCQs With Answer

Introduction:
Quality Assurance (QA) under Good Laboratory Practice (GLP) is essential for ensuring the integrity, reliability, and traceability of non-clinical laboratory studies. For M.Pharm students, understanding the QA unit’s roles, responsibilities, and boundaries is critical for managing preclinical safety studies, audits, SOP governance, and regulatory inspections. This blog presents focused MCQs that probe key aspects of the QA unit and its GLP responsibilities — including independence, monitoring, documentation control, auditing of subcontractors, handling deviations, equipment calibration, archiving and training. These questions are designed to deepen conceptual understanding and prepare students for real-world QA tasks in pharmaceutical research and regulatory environments.

Q1. What is a fundamental organizational requirement for the QA unit under GLP?

• Be integrated within the study team and report only to the study director
• Organizationally independent from study conduct and having direct access to management
• Belong to the regulatory authority and perform external inspections only
• Function as a part of the Quality Control laboratory for data verification

Correct Answer: Organizationally independent from study conduct and having direct access to management

Q2. What is the primary responsibility of the QA unit in GLP-regulated studies?

• Designing the scientific aspects of the study protocol
• Conducting all analytical testing for the study
• Monitoring compliance with GLP through audits, inspections and documentation review
• Approving the study sponsor’s budget and timelines

Correct Answer: Monitoring compliance with GLP through audits, inspections and documentation review

Q3. Regarding access to study records and raw data, the QA unit should:

• Access only final reports but not raw data to avoid bias
• Have full, unrestricted access to all raw data, study records and supporting documentation
• Request records through the Study Director on a need-to-know basis
• Only review copies of records retained by Quality Control

Correct Answer: Have full, unrestricted access to all raw data, study records and supporting documentation

Q4. What is an appropriate role of QA prior to study initiation under GLP?

• Approve the scientific design and dose selection for the study
• Verify that SOPs, facilities, equipment and materials are adequate and that necessary documentation is available
• Create the final study report on behalf of the Study Director
• Perform all stability testing for test items

Correct Answer: Verify that SOPs, facilities, equipment and materials are adequate and that necessary documentation is available

Q5. Under GLP, who has the ultimate responsibility for the scientific conduct and conclusions of a non-clinical study?

• The Quality Assurance Unit
• The Sponsor’s regulatory affairs officer
• The Study Director
• The Head of Quality Control

Correct Answer: The Study Director

Q6. Can the QA unit change raw data or final study reports to correct observed problems?

• Yes, QA can directly edit data to correct errors
• No, QA may not alter raw data or final reports but must document nonconformities and recommend corrective actions
• Yes, if the Study Director authorizes the changes
• No, QA must destroy any questionable raw data

Correct Answer: No, QA may not alter raw data or final reports but must document nonconformities and recommend corrective actions

Q7. When should QA conduct inspections of a GLP study?

• Only at the end of the study to prepare the final report
• Only before the study starts to approve SOPs
• At critical stages: pre-study, periodically during the study, and post-study close-out
• Only when a regulatory authority announces an inspection

Correct Answer: At critical stages: pre-study, periodically during the study, and post-study close-out

Q8. What is the QA unit’s appropriate role concerning Standard Operating Procedures (SOPs)?

• Create SOPs without involving test facility management
• Review and audit SOPs for adequacy, ensure they are controlled and monitor adherence
• Destroy outdated SOPs immediately without archiving
• Delegate SOP approval entirely to external consultants

Correct Answer: Review and audit SOPs for adequacy, ensure they are controlled and monitor adherence

Q9. Which items should QA reports typically document following inspections?

• Only the positive findings to show compliance
• Detailed findings including deviations, non-compliances, recommendations and timelines for corrective action
• Only financial discrepancies unrelated to GLP
• Internal staff performance reviews and salary details

Correct Answer: Detailed findings including deviations, non-compliances, recommendations and timelines for corrective action

Q10. What is the role of QA with respect to equipment calibration and maintenance under GLP?

• Perform all calibrations personally
• Ensure calibration/maintenance schedules exist, verify records and that equipment is suitable before use
• Ignore calibration records as they are QC responsibility
• Discard calibration records after the study begins

Correct Answer: Ensure calibration/maintenance schedules exist, verify records and that equipment is suitable before use

Q11. When a study uses subcontractors or external laboratories, the QA unit should:

• Assume subcontractors are compliant without verification
• Audit and monitor subcontractor facilities and records to ensure GLP compliance
• Allow subcontractors to self-certify and accept their word
• Exclude subcontractor work from study reports

Correct Answer: Audit and monitor subcontractor facilities and records to ensure GLP compliance

Q12. Who is responsible for approving and signing the final study report in GLP studies?

• The Quality Assurance Unit
• The Study Director
• The Head of Human Resources
• The Sponsor’s legal counsel

Correct Answer: The Study Director

Q13. How does QA ensure personnel competence under GLP?

• By ensuring training programs exist and maintaining personnel training and qualification records
• By conducting all laboratory experiments themselves
• By relying on CVs without verifying training
• By hiring only staff with prior GLP experience and not training them

Correct Answer: By ensuring training programs exist and maintaining personnel training and qualification records

Q14. Upon discovery of a major noncompliance during a GLP inspection, QA should first:

• Ignore it if studies are near completion
• Report it to test facility management, document it, initiate corrective and preventive actions, and re-inspect
• Immediately destroy all related records to avoid regulatory findings
• Inform only the study sponsor and not facility management

Correct Answer: Report it to test facility management, document it, initiate corrective and preventive actions, and re-inspect

Q15. What is the QA unit’s responsibility regarding study archiving?

• Ensure proper archiving, security, retrievability and control of access to study records
• Dispose of archived records after one week
• Archive only financial documents and ignore raw data
• Transfer archives to the sponsor without inventory control

Correct Answer: Ensure proper archiving, security, retrievability and control of access to study records

Q16. What best distinguishes Quality Assurance from Quality Control in a GLP environment?

• QA performs laboratory testing; QC manages systems and procedures
• QA is system- and process-focused to ensure compliance; QC is product- and test-focused for analytical verification
• QA is only responsible for marketing; QC handles documentation
• There is no difference; both perform identical tasks

Correct Answer: QA is system- and process-focused to ensure compliance; QC is product- and test-focused for analytical verification

Q17. Which responsibility lies with the test facility management under GLP in support of QA?

• Providing adequate resources, facilities, SOPs and support to enable GLP compliance
• Performing all QA audits personally
• Approving scientific conclusions of studies without peer review
• Suppressing QA findings to avoid delays

Correct Answer: Providing adequate resources, facilities, SOPs and support to enable GLP compliance

Q18. How should QA handle protocol deviations discovered during a study?

• Conceal deviations to prevent regulatory action
• Document deviations, assess impact on study integrity, report to management and recommend corrective actions
• Ignore deviations unless the Study Director complains
• Rewrite the protocol to match what was done

Correct Answer: Document deviations, assess impact on study integrity, report to management and recommend corrective actions

Q19. During a regulatory inspection of a GLP facility, the QA unit’s most appropriate role is to:

• Prevent the inspectors from seeing raw data
• Coordinate the facility’s response, facilitate access to records and accompany inspectors while preserving independence
• Make verbal promises to inspectors without documentation
• Refuse to allow any contact between inspectors and study staff

Correct Answer: Coordinate the facility’s response, facilitate access to records and accompany inspectors while preserving independence

Q20. Maintaining independence and avoiding conflicts of interest is important for the QA unit because:

• It allows QA to produce study data when needed
• It ensures objective assessment of compliance and prevents influence by those conducting the study
• It reduces the need for documentation and audits
• It enables QA to set scientific endpoints for studies

Correct Answer: It ensures objective assessment of compliance and prevents influence by those conducting the study

Download