Remote auditing survey reveals a preference for in-person audits

Survey of clients and auditors assessed how well remote auditing fulfilled clients’ needs during COVID 19-related disruption and the longer-term preferences now emerging.

Stevenage, Hertfordshire, UK – June 16th, 2022 –  New research conducted by Rephine, a firm of deeply experienced GMP auditors specialising in pharma supply-chain quality assurance, reveals that both pharma clients and auditors are keen to see a return to in-person audits as COVID 19-related restrictions continue to be lifted.

Before the pandemic, the pharma industry and its regulators would not have entertained the concept of remote audits to verify that the manufacturing and distribution standards of supply-chain partners were being maintained. But that changed as lockdowns, social distancing and travel restrictions disrupted normal conditions. Rather than curtail audits altogether, regulators including the European Medicines Agency (EMA) agreed to virtual assessments being conducted online, as a temporary measure allowing generic manufacturers to continue to qualify their suppliers.

To understand more fully how the industry has adapted its auditing activities and expectations and the impact this has had, and to gauge emerging priorities going forward, in February 2022 Rephine polled its pharma clients and senior auditors internationally for their views.

For both respondent groups, the greatest challenge with remote auditing proved to be the lack of a site tour, to enable sufficiently granular insight into facilities and practices – primarily because the auditees are in control of what is shown.

Further reflecting the lack of trust in remote auditing as a permanent solution, two-thirds of pharma clients said they wouldn’t accept a remote-only audit as a means of qualifying a new API supplier. Auditors responded similarly. Too much would be left to interpretation, it was felt.

Following the same logic, almost two-thirds of client company QA respondents said they would not be comfortable going more than two years before re-auditing, following a remote inspection: a fifth said they would want to redo the audit within a year. For auditors taking part in the survey, two-thirds said they would look to re-audit within a year following a remote-only inspection.

In future, two-thirds of audit clients suggested they would accept a hybrid approach to supplier auditing, in which routine aspects such as sharing and completing documentation could be done remotely while on-site inspections took place physically. A third said they would favour a return to 100 per cent in-person audits. Only 1 customer organisation expressed a preference for persisting with remote audits across both the documentation element and physical inspections.

Meanwhile, almost all survey participants favoured the idea of working with an independent third-party auditor to generate a single, comprehensive report that could be shared with multiple customers, to reduce risks associated with allowing multiple auditors on site over 1-3 years.

It was through conducting this kind of activity that Rephine’s own auditors were able to continue conducting on-site audits throughout the pandemic. Although numbers of physical audits halved during 2020 in favour of increased remote activity (and the sharpest reduction in activity was between March-May 2020), by 2021 highly accredited auditors located on the ground in target markets were largely back on site – with 82 per cent inspections conducted in person and just 11 per cent done virtually (compared to a ratio of 72 per cent on-site/28 per cent remote audits in 2020).

Commenting on the research, Alasdair Leckie, Operations Manager at Rephine Ltd, said, “Whatever allowances have been made by regulators over the last two years, the onus is on all manufacturers and suppliers to maintain regular auditing activity, to safeguard patient safety and to maintain their own industry reputation. Indeed, one of the useful disciplines encouraged by regular inspections is that of being audit-ready (in other words, maintaining consistently high standards) at all times.

“The key to maintaining high standards of supplier compliance will depend on continued, tailored vigilance – via the optimum blend of audit approaches, underpinned by prompt on-site re-audits as soon as is humanly possible,” he continued. “With the best will in the world remote inspections cannot go into sufficient detail compared to on-site audits, meaning there is a risk that something important might be overlooked.”

The full report, Is remote GMP auditing in pharma viable in the long term? is available to download here.


About the research

Rephine conducted the research into attitudes to remote GMP auditing in pharma through a combination of phone, online and face-to-face interviews in February 2022, with both pharma clients and senior auditors internationally. Of the ~30 people polled, just over half were in the Quality function of pharma companies (the balance comprising professional auditors), and around two-thirds of responses were from Europe, the remainder primarily from Asia – most notably India.

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