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 EU GVP module IV provides a detailed explanation of the purpose, plan, process, report, etc. of internal audit, and in section IV.B.3.1.2, the requirements for the qualifications of internal audit personnel are explained. The following quote is cited: Auditors should demonstrate and maintain expertise in terms of the knowledge, skills and abilities required to effectively conduct and/or participate in pharmaceutical audit activities The qualification of audit team members will have been trained through a combination of education, work experience and training, as a team, should cover knowledge, skills and abilities in: • audit principles, procedures and techniques; • Applicable laws, regulations, and other requirements relevant to pharmacovariance; • Pharmacovigilance activities, processes and system (s); • Management system (s); • Organizational system (s) '