MHRA Prepares For Safe Return To On-Site Inspections In UK
A Hybrid Model Of On- And Off-Site Activities Will Support A Single Inspection Cycle
Four months after suspending all non-essential on-site inspections because of the COVID-19 pandemic, the UK medicines regulator is busy finalizing the practical arrangements needed to resume these safely at local sites.
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New guidance explains how UK-based sites and organizations can facilitate routine on-site good practice inspections that are due to restart next month.
Experience from previous viral outbreaks has allowed the UK agency to move quickly; long-term focus is on hybrid inspection approach.
Agency resuming domestic inspections with the help of a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.