Like other surveillance authorities, the UK Medicines and Healthcare products Regulatory Agency MHRA had suspended its on-site GxP inspection programme in the wake of the pandemic and related restrictions.
Now, domestic on-site inspections are to be carried out again from 29 March 2021. For this purpose, a combination of remote and on-site inspection approaches will be used after appropriate risk assessment. In doing so, the MHRA wishes to reduce the regulatory burden on businesses as much as possible during the COVID 19 pandemic, but stresses that this should "not impact on the Agency's regulatory powers to inspect".
The MHRA now outlines the expectations to be considered during on-site inspections and their preparation, taking into account current government guidance on minimising risk to personal safety. MHRA will continue to prioritise inspections with relevance to pandemic response or with potential serious risks to public health.
What are the key points of the Guidance?
Inspections are usually announced 14 days in advance (justified exceptions are possible),
Discussion of risk assessment, logistics and potential difficulties between the lead inspector and the inspected site thereafter,
Determine what can be assessed remotely and how. For this purpose, as much documentation as possible is requested in advance; part of it is checked off-site, if necessary by remote access to necessary information,
Sufficient staff should be available (remotely if necessary) to facilitate the inspection,
A dedicated work area is needed on site that allows for social distancing. Site visits are discussed in advance,
Attendance at face-to-face opening and closing meetings and necessary inspection interviews will be kept to a minimum,
Interviews are scheduled for longer periods of time if possible and can also take place via video conferencing, Interviews needed at short notice can also take place via telephone or other technologies,
Minimising the number of staff accompanying site visits,
On-site provision of documents by electronic means is also preferred (use of MHRA laptops).