Remote Pharmacovigilance Inspections of MAHs During Pandemic
Regulatory and procedural guideline and points to consider
Inspection over MAHs' pharmacovigilance system, has become a challenge during pandemic crisis since on-site inspections may not be possible due to multiple factors such as flight and traveling restrictions, transportation difficulties, and most importantly, health risks for both inspectors and inspectees. Hence on-site inspections have been replaced with the alternative route, remote inspections.
As remote inspections should follow certain guidelines and procedures that already exist, if it can not provide sufficient grounds for the inspectorate to gain an adequate overview of the functioning of the PV system over remote inspection, postponed on-site inspection should be considered.
The following document outlines the specificities and main points of remote PV inspections for MAHs with Centerally Authorized Products (CAP) and National Authorized Products (NAP) to ensure a well ordered procedure.
Remote Pharmacovigilance Inspections of MAHs During Pandemic
At Pharmazet we do have an experience with PV audits for centrally approved products so please do not hesitate to come back to us if we can be of any help.