Routine and triggered inspections may be conducted by inspectors remotely. These inspections are conducted through review of requested documents including evidence to support pharmacovigilance activities and submissions. The document review is supplemented with telephone interviews with relevant subject matter experts and written responses to specific queries. Logistical aspects of the inspection, including timings and availability of specific subject matter experts and the QPPV for telephone interview, are arranged with the inspected organisation prior to the inspection. An onsite inspection may be triggered following the remote inspection, should any significant non-compliance or concerns that require further investigation be identified.
Routine and triggered inspections may be conducted by inspectors remotely. These inspections are conducted through review of requested documents including evidence to support pharmacovigilance activities and submissions. The document review is supplemented with telephone interviews with relevant subject matter experts and written responses to specific queries. Logistical aspects of the inspection, including timings and availability of specific subject matter experts and the QPPV for telephone interview, are arranged with the inspected organisation prior to the inspection. An onsite inspection may be triggered following the remote inspection, should any significant non-compliance or concerns that require further investigation be identified.
