Guidance for industry on MHRA’s expectations for return to UK on-site inspections

Update on MHRA UK risk-based GxP inspection programme.

MHRA suspended our on-site GxP inspection programme on 5 January 2021 in response to COVID-19 social distancing and travel restriction requirements.

In line with current Government advice, the inspectorate will resume an on-site UK risk-based GxP inspection programme from 29 March 2021. The MHRA Inspectorate will continue to use a combination of remote and on-site inspection approaches. The MHRA is committed to working with industry to reduce regulatory burden during the COVID-19 pandemic wherever possible, including flexible approaches to inspection, however, this does not impact on the Agency’s regulatory powers to inspect.

This guidance describes the points to consider for on-site inspections as the UK Government and Devolved Administrations implement their roadmaps to ease restrictions across the UK. The guidance is designed to allow the MHRA to fulfil their public health duties, whilst following the current government guidelines and minimising risk to personal safety. We will continue to prioritise inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk.

Inspections in all settings will usually be pre-notified with a minimum of 14 days notice to enable COVID-19 risk mitigation planning to take place with the inspected site/organisation. When short notice or unannounced inspections are necessary for public health reasons, inspectors will discuss COVID-19 risk mitigation measures with the organisation on arrival. Inspectors will accommodate reasonable requests in respect of PPE, social distancing and the organisation’s workplace practices.

Inspection planning

Following receipt of an inspection notification, risk assessment and logistics should be discussed between the lead inspector and the inspected site or organisation so that expectations of both parties are clear. The MHRA and the inspected site or organisation should ensure implementation of current UK Government guidance. If difficulty in implementing government guidelines in one or more areas of the inspection is anticipated, this should be discussed during the planning phase.

Part of the inspection planning process will be to determine what can be assessed remotely. The inspection teams will request as much documentation as possible in advance of the inspection and some of this will be reviewed off-site. The MHRA continues to work with industry to use technology that enables remote access to information where possible.

Inspectors will not expect sites or organisations to produce verified copies of paper data solely for inspection use (i.e. to scan an entire study/trial or data package). Where difficulties are anticipated in respect of paper documents, this should be discussed with the lead inspector prior to arrival.

The MHRA does not expect a physical inspection backroom, but personnel should be available (including remotely, where necessary) to facilitate the inspection. There is no expectation for personnel who would not normally be on site to attend the inspection (e.g. corporate representatives or other personnel who would not routinely attend the site during the COVID-19 pandemic).

Working space that enables social distancing will be required on site. Where anticipated, facility tours will be discussed during the planning stage to ensure social distancing guidelines can be followed. Discussions regarding the use of PPE and IT connectivity will be part of the planning process.

Inspection conduct

The inspection will be performed by the minimum number of inspectors who will also be socially distanced from each other. This may include trainees who are able to contribute to the inspection but it will not include observers.

Social distancing measures require minimum face to face interaction. Participation in face to face opening and closing meetings and other inspection interviews should be kept to the minimum number of essential staff. Interviews will be scheduled with as much notice as possible to reduce the number of people required in the inspection room and may be via video conference, even if these personnel are in the same building.

Organisations should minimise the number of personnel accompanying facility tours. Additional support from subject matter experts may be provided by telephone or other technology.

Provision of documents via electronic means is preferred when on site, which will be reviewed on MHRA laptops wherever possible. This may be as electronic copies, or screen sharing video conference technology.

Inspection follow-up

The MHRA and the site/organisation should inform each other if anyone directly connected with the inspection tests positive for COVID-19 within 10 days of the on-site phase of inspection.

Published 11 August 2020
Last updated 19 March 2021 + show all updates
  1. Updated guidance on how and when on-site inspections will resume at the end of March

  2. First published.