On-site GxP inspections to resume in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a resumption of their on-site GxP inspection activities from 29 March 2021.

Inspections were halted on 5 January 2021 in line with social distancing and travel restrictions imposed due to COVID-19. As these restrictions begin to ease, the agency will re-commence on-site inspection activities. This is not the first time on-site inspections have been disrupted by the COVID-19 pandemic. Inspections were initially suspended in March 2020, before resuming in September 2020.

The way in which the MHRA Inspectorate will resume work in March 2021 is largely the same as it did in September 2020. A system where organisations receive 14 days’ notice prior to an inspection to enable COVID-19 risk mitigation planning will remain in place. In instances where inspections are conducted unannounced or on short notice, the inspectors will discuss COVID-19 risk mitigation measures (such as social distancing, personal protective equipment and the use of video conferences even when in the same building) with the organisation on arrival.

As before, the inspection team will request as much documentation as possible in advance, to maximise the amount of work that can be done off-site. Furthermore, in order to minimise face-to-face interactions and ensure social distancing between all individuals involved with the on-site inspection, the inspection will be performed with the least number of inspectors possible. In addition, the inspected organisations should ensure a minimal number of personnel accompany facility tours.

Both the MHRA and the inspected organisation should inform one another if anyone directly connected with the inspection returns a positive COVID-19 test within 10 days of the on-site phase of the inspection.

To read the full guidance, click here.