Answer： Article 18 of the "Quality Management Standards for Pharmacovigilance" states that the holder shall regularly audit the entrusted party, requiring the entrusted party to fully understand the quality objectives of its pharmacovigilance and ensure that the pharmacovigilance activities continue to meet the requirements. There are various forms of auditing, and the "Quality Management Standards for Pharmacovigilance" do not specify the auditing form. It is recommended that the holder develop an auditing plan in accordance with Article 12 of this standard and execute it. The plan should include the objectives, scope, methods, standards, auditors, audit records, and reporting requirements of the internal audit.