MHRA Guidance on Resuming UK On-Site GxP Inspections

Comprehensive Summary

This guidance outlines the MHRA's expectations for resuming on-site GxP inspections in the UK following the COVID-19 suspension, starting from 29 March 2021. It emphasizes a risk-based approach combining remote and on-site methods, prioritizes inspections linked to public health risks, and incorporates flexible practices to minimize regulatory burden while adhering to government guidelines on social distancing and safety. Key aspects include pre-notification, remote document review where possible, minimal inspector numbers, social distancing during inspections, and post-inspection follow-up for COVID-19 cases. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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). https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

Organisations should minimise the number of personnel accompanying facility tours. Additional support from subject matter experts may be provided by telephone or other technology. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections

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. https://www.gov.uk/guidance/guidance-for-industry-on-mhras-expectations-for-return-to-uk-on-site-inspections