News about GMP/cGMP

25.03.2021

MHRA to pick up on-site inspections by end of March

MHRA to pick up on-site inspections by end of March

The MHRA announces its return  to on-site risk based GxP inspections starting from 29 March 2021. However, it is planned to use a combined approach of both, remote and on-site inspections.


What has to be considered? 

  • The authority will pre-notifiy an on-site inspection within a minimum of 14 days in advance.

  • There will be a reasonable request for a minimized number of personnel on site, only. 

  • Social distancing will be given a top priority and a necessary remote standby of personnel will be discussed beforehand. 

  • Provision of documents via electronic means is preferred once on site, as well as in advance of physical linspection 

  • A physical inspection backroom is not expected but rather a workspace for inspectors allowing them social distancing. 

 

A detailed guidance for industry on the MHRA’s expectations is provided here.


Source:

 

MHRA: Update on MHRA UK risk-based GxP inspection programme 


 

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