Monday 4 October 2021

What To Expect From A Remote Inspection -- & How To Navigate It


The 2020–2021 coronavirus pandemic has caused multiple changes across the pharmaceutical and healthcare industries. One such difference has been the move toward remote inspections. To address this new approach, both parties (regulatory inspectors, such as FDA; and inspectees, such as pharmaceutical, biotech, or medical device companies) need to make changes relating to technology and culture. Given that this model will also continue, to an extent, post-coronavirus, it is important that organizations prepare for remote inspections.


This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.


The general success of the model may lead to remote inspections becoming part of the normal inspection process.


Sandle, T. (2021) What To Expect From A Remote Inspection -- & How To Navigate It, Pharmaceutical Online, 23rd July 2021, at:


 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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