ALASDAIR LECKIE
Rephine, Stevenage, Hertfordshire, United Kingdom

Abstract

The COVID-19 pandemic saw pharma industry auditing move increasingly online and in place of on-site visits, we became familiar with virtual checks and inspections. Some auditors now say that virtual auditing could become a permanent solution, but deeper analysis shows that clients are not in favour of this option, says Alasdair Leckie, Operations Manager at Rephine Ltd.

There was a time that pharma regulators would never have considered the idea of remote audits to verify the manufacturing and distribution standards of supply-chain partners, but two years of pandemic have forced the industry to adapt.

Regulators such as the European Medicines Agency (EMA) adapted their audit requirements to ensure that inspections could still take place, including making provision for virtual assessments to be conducted online. But this was only ever intended as a temporary measure and although remote audits are convenient, standardising on them in the longer term is untenable.

Even the most diligent remote inspection cannot go into sufficient detail compared to an on-site audit, and there is a risk that something important might be overlooked. That could be something as seemingly innocuous as a cracked floor – which could present a hazard, breaching compliance. Even in a live remote session with a video link, this kind of transgression could be missed if cameras are not directed into every corner.

To gauge companies’ priorities post pandemic, in February 2022 Rephine conducted internation ...