During unexpected emergencies, like COVID-19, conducting on-site pharmacovigilance (PV) inspections are not feasible due to travelling difficulties, orders from local authorities, and restrictions to accessing facilities justified by health hazards. Under such conditions, remote inspections would become the most preferable, replacing on-site inspections. 

Considering the same, EMA has recently revised the guidance on the steps to be followed during remote pharmacovigilance (PV) inspections for Marketing Authorization Holders (MAH). The purpose of this document is to help MAHs outline the specificities of remote Pharmacovigilance inspections by identifying the inspection requirements for centrally authorized products (CAPs) and nationally authorized products (NAPs).

The revised contents include the following:

  • The word 'distant/virtual' pharmacovigilance (PV) inspections have been changed to 'remote' pharmacovigilance inspections.
  • Clarifications on the technical requirements for remote access to electronic systems and to maintain communication.
  • Further inputs on the documentation and preparation conduct.

An inspection announcement letter, along with the technical requirements, a list of required documents as well as the preparation procedure will be sent to the facilities. Timely provision of all necessary documentation and a robust set-up of the technical facilities ensures feasibility and smooth functioning of the remote inspection.

With these guidelines announced, MAHs must be prepared with all the technical and documental requirements. Is your facility or process inspection-ready? Get an expert analysis on inspection preparedness. Opt for a pharmacovigilance expert to avoid any hassles.

Stay informed. Stay updated.


Related Posts by Category