Remote audit: reflections on the global transformation of inspections during the COVID-19 Pandemic

In August 2020 the International Coalition of Medicines Regulatory Authorities (ICMRA) established a working group “Remote GCP and GMP Regulatory Oversight Inspections” that has published a report entitled “Reflections on the regulatory Experience of remote Approaches to GCP and GMP regulatory Oversight during the COVID-19 Pandemic

ICMRA is a voluntary association of internationally cooperating medicines regulatory authorities

The International Coalition of Medicines Regulatory Authorities (ICMRA) set up this working group to focus on the transition from GCP and GMP inspections to remote inspections during the pandemic. The working group was chaired by the UK MHRA and included representatives from the US FDA, EMA, Health Canada, Swiss-medic, HPRA Ireland, AEMPS Spain, ANSM France, PEI Germany, MHLW/PMDA Japan, TGA Australia, ANVISA Brazil, HSA Singapore, WHO, and Saudi FDA.

The purpose of this paper is to report reflections based on combined experience during conducting remote assessments, inspections, and determinations of GCP and GMP regulatory activities conducted globally shared through the workgroup during 2020-21.

Obviously, variable experience is reported across inspection types and areas, sites, and jurisdictions.

Experiences with different types of digital means, such as visual technology, are also discussed.

Essentially the ICMRA working group conveyed that remote inspections cannot replace regular and routine on-site GMP inspections, but they have allowed regulators to maintain a minimal oversight program. Some regulators expressed interest in continuing to supplement their inspections with remote inspections and/or hybrid approaches in the future, or even replacing an on-site inspection completely in some cases, such as to address an urgent concern, to support an application evaluation and approval decision, or to review certain corrective/preventive actions.