The future of remote pharma GMP auditing

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.