According to the Good Laboratory Practice regulations, the Quality Assurance unit shall:

• A. be composed of five members
• B. meet at least monthly
• C. include a veterinarian
• D. be independent of the personnel conducting the study.

Answer: (D)

Independence of the Quality Assurance unit from the personnel conducting the study. In GLP, QA serves as an objective observer to verify that studies are conducted, records are kept, and data are reported according to protocol and regulatory requirements. If QA were part of the study team, there could be conflicts of interest or bias that might mask deviations or noncompliance. An independent QA unit has the authority to inspect facilities, procedures, and records and to report findings to higher management, ensuring that any deviations are identified and addressed without undue influence from those conducting the work.

The other options aren’t required features of GLP: there’s no fixed size for the QA unit, no specified meeting frequency, and no mandatory inclusion of a veterinarian in the QA unit. The essential point is that QA remains independent of the study personnel to preserve objectivity and data integrity.