On-site GxP Inspection Programme

Published: 28/8/2020

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

The MHRA has announced on August 11th., 2020 that the agency/inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September and scaling up to a full programme from October 2020, as the initial programme was suspended on March 20th, in response to COVID-19 pandemic and travel restriction and social distancing requirement.

In order to allow the MHRA to fulfil their public health duties, whilst following the current government guidelines and ensuring the safety of all personnel, a specific guidance that describes the considerations for on-site inspections has been released by the agency and it is continuously updated as per the latest UK Government news.
As part of this new programme, the MHRA will request as much documentation as possible in advance and some of this may be reviewed off-site. The inspection will be performed by the minimum number of inspectors. Also, the inspectors will not expect sites or organisations to produce verified copies of paper data solely for inspection use, are among the measures that will be implemented.

Additional details can be found on the following link: https://www.gov.uk/…o-uk-on-site-inspections

If you are looking for further guidance and consultancy on the matter, you can contact us via info@pharmazet.com

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