Is remote pharma GMP auditing a viable long-term proposition?

At the height of the pandemic, most pharma GMP auditing moved online, so that checks and inspections could continue, albeit virtually. Some service providers have suggested this practice could persist, yet many professional auditors– as well as pharma clients – fear this would mean a loss of control. So we commissioned a survey to gauge the market mood.

Pre-pandemic, remote audits to verify pharma manufacturing and distribution standards would have been unthinkable. But COVID-19 changed that, as lockdowns, social distancing and travel restrictions disrupted normal conditions. Rather than curtail audits altogether, regulators adapted. In Europe, as well as allowing a grace period within the auditing cycle, EMA relaxed the requirement for inspections to be on-site.

Yet, with the best will in the world virtual inspections cannot go into the same detail as on-site audits, creating a risk that something important could be overlooked – or glossed over. To gauge opinion about whether virtual audits might be a sustainable longer-term option, we conducted some research.

Of the ~30 people we 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.

Both groups (clients and auditors) expressed concern about the prospect of remote auditing continuing indefinitely, because of the lack of control over the more granular insights needed. (There’s much less scope for auditors to spontaneously go off plan if they have a hunch about something).

Can remote audits ever be truly trusted?
Unsurprisingly perhaps, 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 without the chance to meet teams and assess facilities and processes in person.

A similar proportion of QA professionals said they wouldn’t be happy going more than two years before re-auditing following a remote inspection: a fifth would want to redo the audit within a year.

Could a hybrid approach be the way forward?
Looking to the future, two-thirds of pharma clients suggested they would be happy with 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 client wanted to persist with entirely remote audits.

A combined, consolidated approach to audits won a lot of interest, however. This model involves working with an independent third-party auditor (such as Rephine) to generate a single, comprehensive report that can be shared with multiple customers, avoiding the need for multiple auditors to attend a site over 1-3 years.

Ultimately, remote auditing should only ever be seen as a support activity to the main event, whatever the future holds.

You can download a copy of the full report here.

Alasdair Leckie, Operations Manager, Rephine

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