Remote Audits and Inspections of Pharmacovigilance Systems

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Never has there been so much of a test for business continuity plans (BCP) than in 2020, a year when due to the onset of a global pandemic, face-to-face personnel interactions ceased, offices closed and travel plans were cancelled. However, business has continued, as has the expectation to maintain the quality of systems in order to protect the quality and efficacy of medicinal products and the safety of patients.

This booklet draws on the experience of the authors, both prior to and during the period of the COVID-19 pandemic to provide guidance, hints and tips on conducting pharmacovigilance (PV) audits remotely. Consideration has also been given to mechanisms for support pf PV regulatory inspections.

While the booklet focuses on the conduct of PV audits according to GVP requirements, the concepts can be commonly applied across the GxPs.

Contents 

1. Introduction
2. Set up and conduct of remote pharmacovigilance audits
3. Document-based remote auditing
4. Technology
5. Pros and cons of auditing remotely
6. Remote audit checklist
7. And finally...

Authors

Pam Bones and Lauren Ewen

Published

March 2021