MHRA to resume on-site inspections

The Medicines and Healthcare products Regulatory Agency (MRHA) have released guidance detailing their plans to resume on-site GxP inspections in September 2020.

On-site GxP inspections were suspended in March 2020 due to social distancing and travel restrictions in response to COVID-19. As restrictions are now easing, on-site inspections will commence again from September, reaching maximum capacity by October.

Organisations will usually receive a minimum of 14 days’ notice to enable COVID-19 risk mitigation planning. 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, such as personal protective equipment (PPE) and social distancing.

The MHRA will request as much documentation as possible in advance, which may be reviewed off-site. As social distancing measures require minimum face-to-face interaction, the inspection will be performed by the least number of inspectors possible. Furthermore, organisations should minimise the number of personnel accompanying facility tours. The inspector will review documents electronically via laptop where possible.

The MHRA and inspected organisation should inform each other if anyone directly connected with the inspection tests positive for COVID-19, within 7 days of the on-site inspection.

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