News about GMP/cGMP

14.08.2020

MHRA: Risk-based resumption of on-site inspections in September

After the US FDA already announced the gradual resumption of on-site surveillance inspections in May (we reported), the MHRA is now also following this course. The short Guidance for industry on MHRA's expectations for return to UK on-site inspections published on 11 August 2020 sets out the procedure.   

There you will find information on  

  • Planning,   
  • Implementation  
  • And follow-up of inspections.  

The programme is to start in September and will be fully scaled up from October 2020. The regulatory burden associated with the COVID 19 pandemic should be reduced. Inspections are usually announced 14 days in advance so that the facility to be inspected can take appropriate measures to minimize the risk of infection.
A flexible approach to inspections and videoconferences, where possible, should ensure the safety of all parties involved. The number of persons present during the inspection should be kept to a minimum. Documents are requested and reviewed by the MHRA in advance as far as possible. 


Source:

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



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