MHRA’s Expectations for Return to UK On-site Inspections

On 11 August 2020 the MHRA published the guidance for industry on planning to resume on-site UK risk-based GxP inspections in September.

In line with a reduction in restrictions, the inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September, scaling up to a full programme beginning in October 2020. This programme will use a combination of remote and on-site inspection approaches as COVID-19 restrictions are eased. The MHRA is committed to working with industry to reduce regulatory burdens during the COVID-19 pandemic wherever possible, including flexible approaches to inspection, but this does not diminish or impede the agency’s regulatory powers to inspect.

This guidance describes the points to consider for on-site inspections as the UK Government updates the pandemic restrictions. This will allow the MHRA to fulfil their public health duties, while following the current government guidelines and ensuring all personnel are safe.

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