UK’s MHRA To Resume On-site Risk-based Inspections in SeptemberBy
The UK’s Medicines and Healthcare products Regulatory Agency reports that it plans to resume on-site UK risk-based GxP inspections in September (September 2020) and scale up to a full program in October (October 2020).
The agency had suspended its on-site GxP inspection program on March 20, 2020 in response to COVID-19 social distancing and travel restriction requirements. Earlier this month (August 2020), it issued guidance for the resumption of on-site inspections as the UK government updates its COVID-19 pandemic restrictions.
The agency says that 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/organization. When short notice or unannounced inspections are necessary for public health reasons, inspectors will discuss COVID-19 risk-mitigation measures with the organization on arrival. Inspectors will accommodate reasonable requests with respect to personal protection equipment, social distancing, and the organization’s workplace practices where this does not impede the inspection.
Following receipt of an inspection notification, the MHRA advises that risk assessment and logistics should be discussed between the lead inspector and the inspected site or organization so that expectations of both parties are clear. The MHRA says it will request as much documentation as possible in advance, and some of this may be reviewed off-site. It says that part of the inspection-planning process will determine what can be assessed remotely, and the agency says it is willing to work with industry to use technology that enables remote access to information where possible.
The MHRA says it does not expect a physical inspection backroom, but personnel should be available (including remotely, where necessary) to facilitate the inspection. The agency says 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 personal protection equipment and IT connectivity will be part of the planning process.
As part of the inspection follow-up process, the MHRA and the site/organization should inform each other if anyone directly connected with the inspection tests positive for COVID-19 within seven days of the onsite phase of inspection.