Pharmaceutical remote auditing: Best practices during COVID-19 and beyond


Rx-360, USA

In late 2019 and into early 2020 as the world started to understand the real time as well as the future impact of coronavirus, everyone within the pharmaceutical industry needed to adapt and become very nimble, very quickly.


At Rx-360 we became aware very quickly as to how the global pandemic could and would affect pharmaceutical supply chain integrity as well as the quality of its materials.  Traditionally the industry has primarily relied on maintaining quality through the use of onsite audits, conducted either by their own organizations internal auditors or access to a supplier through a third party auditor.  With supplier sites being greatly affected by the pandemic and industry not having access to the supplier sites, remote auditing was thrust to the forefront.  Questions arose, how do we develop a remote audit program?  Is a remote audit as good as an onsite audit?  If we move to a remote audit model, is it temporary or permanent?