根据中国《药物警戒质量管理规范》第十一条  持有人应当定期开展内部审核（以下简称“内审”），审核各项制度、规程及其执行情况，评估药物警戒体系的适宜性、充分性、有效性。当药物警戒体系出现重大变化时，应当及时开展内审。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章节对内审人员做如下要求：

‘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)’.

         建议持有人建立内审制度，明确内审类型、频率及基于风险的考量等，确保内审的计划、开展、报告等符合法规要求。