MHRA: In-person inspections to start 29 March
Pharmaceutical firms in the United Kingdom should prepare for on-site inspections to resume at the end of March, according to a Wednesday update issued by the Medicines and Healthcare products Regulatory Authority (MHRA).Beginning 29 March, MHRA’s inspectorate will use a risk-based approach to prioritize in-person inspections, while continuing to conduct remote inspections as well.
“The guidance is designed to allow the MHRA to fulfill their public health duties, whilst following the current government guidelines and minimizing risk to personal safety. We will continue to prioritize inspections linked to the UK Government’s COVID-19 response or any other potential serious public health risk,” wrote MHRA in the updated guidance.
As inspections are planned, MHRA will work to determine which portions of an inspection can be completed remotely, ideally through electronic access to needed documentation and paperwork in advance of the physical inspection.
At the inspection, documents should be provided in a way that allows MHRA inspectors to view them on their own laptops, whenever possible.
When coming on-site, MHRA will not expect the firm to provide a physical inspection backroom, but personnel should be available either in-person or remotely for questions and facilitation as needed. “There is no expectation for personnel who would not normally be on site to attend the inspection,” clarified MHRA.
However, companies should expect to provide a workspace for inspectors that allows social distancing. MHRA will send “the minimum number of inspectors,” which may include trainees but will not include observers. Face-to-face meetings during the inspection will be minimized; MHRA may use video conferencing for some meetings even if the involved personnel are present in the building, for example.
MHRA also expects organizations to do their part to minimize the number of personnel present and accompanying regulators. “Additional support from subject matter experts may be provided by telephone or other technology.”
MHRA