What is the role of the Quality Assurance Unit (QAU) in GLP studies?

• A. Independently audits compliance, verifies data integrity and records, and reports nonconformances.
• B. Designs the study and analyzes the data.
• C. Manages day-to-day laboratory operations.
• D. Writes final regulatory submissions.

Answer: (A)

The main idea here is independent oversight to protect GLP compliance and data integrity. The Quality Assurance Unit operates separately from the study team and conducts audits of study conduct, records, and facilities to verify that everything follows GLP requirements and standard operating procedures. They examine that data are generated, recorded, and stored accurately and completely, and they identify and report any nonconformances so corrective actions can be taken. This objective role helps ensure the credibility of the study results.

The other functions—designing the study, analyzing the data, managing day-to-day lab operations, and writing final regulatory submissions—are handled by the study team, lab management, or regulatory affairs, not by QA.