How should sponsor oversight and QA oversight interact in GLP?

• A. QA defines the scope and approvals; sponsor audits are performed only on QA.
• B. Sponsor defines scope and approvals; QA independently audits and documents nonconformances; both interact but QA remains independent.
• C. Sponsor defines scope but QA has final approval authority for all changes.
• D. QA handles all aspects including scope and approvals.

Answer: (B)

In GLP, the quality assurance function must stay independent from the study sponsor to ensure objective oversight. The sponsor is responsible for defining what the study is supposed to accomplish, outlining the scope, and giving approvals to proceed or make changes. But the actual check on compliance, the audits, and the documentation of any deviations or nonconformances are handled by QA as an independent function. This separation protects the integrity of the study data and processes, providing an unbiased assessment of whether everything meets GLP standards. QA conducts independent audits, records findings, and tracks corrective and preventive actions, while still interacting with the sponsor to address issues. So the right approach is that the sponsor defines scope and approvals, QA independently audits and documents nonconformances, and both work together with QA maintaining its independence.