Answer： According to Article 11 of the Quality Management Standards for Pharmacovigilance, internal audit work can be independently, systematically, and comprehensively conducted by personnel designated by the holder, or by external personnel or experts. The "Quality Management Standards for Pharmacovigilance" do not specify who should develop and approve audit plans, but if they are developed and approved by the pharmacovigilance department, how can the independence of internal audit work be ensured? It is recommended that the internal audit plan be developed by independent internal auditors. It is recommended that the holder establish an internal audit system to clarify the plan, conduct, and report of the internal audit to ensure compliance with regulatory requirements.