Question

Which of the following GLP activities is not the main responsibility of the Quality Assurance unit?

-Is in charge of inspecting and auditing each nonclinical laboratory study
-Checks to be sure that no deviations from approved protocols were made without proper authorization and documentation
-Designates or replaces the Study Director
-Reviews final study reports to ensure that the report accurately describes the protocols that were followed
-Reviews final study reports to ensure that the reported results are accurate

Answer 1

The Quality Assurance unit's responsibility does not include designating or replacing the Study Director; it focuses on study integrity through inspections, protocol adherence, and report reviews.

Step-by-step explanation:

The main responsibility of the Quality Assurance (QA) unit in Good Laboratory Practices (GLP) does not include designating or replacing the Study Director.

The QA unit is primarily focused on ensuring the integrity of the nonclinical laboratory study by various means, including inspecting and auditing studies, checking for adherence to approved protocols, and reviewing final study reports for accuracy and compliance.

However, the responsibility of appointing or changing the Study Director typically lies with the management of the organization conducting the GLP studies since the Study Director is pivotal in planning, conducting, and reporting the studies and should have direct control over these processes.