MHRA Planning for Return to On-site Good Practice (GxP) Inspections

On 23 July 2020 it was published on the MHRA Inspectorate Blog that MHRA is planning for return to on-site GxP inspections.

During the past few weeks, the MHRA inspectors have been engaging with industry trade associations and the NHS to discuss the practical arrangements that may be required to facilitate on-site inspections starting in September and scaling up to a full programme beginning October 2020.

Inspection conduct will vary according to the requirements of each GxP area and may include a hybrid model of on- and off-site activities that support a single inspection cycle.

Further information will be made available later in the summer. Organisations receiving notice of inspection are encouraged to discuss arrangements for personal protective equipment, social distancing, engagement with personnel and access to facilities and information at the earliest opportunity.

Until the full programme resumes, MHRA will continue to conduct its current COVID19 programme of remote assessment. Consistent with previous guidance, on-site inspections linked to the UK Government’s COVID19 response or any other potential serious public health risk, and where remote assessment is not possible, will continue until September as normal programmes resume.

There are currently no plans for a return to international inspections, where we continue to rely on remote assessment procedures and our communication with the international regulatory network. Further information on international inspections will be provided as the situation develops.

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