根据《药物警戒质量管理规范》第十一条，内审工作可由持有人指定人员独立、系统、全面地进行，也可由外部人员或专家进行。欧盟GVP 模块 IV 对内审的目的、计划、流程、报告等进行了详细的阐述，且在IV.B.3.1.2章节阐述了对内审人员资质的要求， 引用如下：

Auditors should demonstrate and maintain proficiency in terms of the knowledge, skills and abilities required to effectively conduct and/or participate in pharmacovigilance audit activities. The proficiency of audit team members will have been gained through a combination of education, work experience and training and, as a team, should cover knowledge, skills and abilities in:

• audit principles, procedures and techniques;

• applicable laws, regulations and other requirements relevant to pharmacovigilance;

• pharmacovigilance activities, processes and system(s);

• management system(s);

• organisational system(s)’.