In the context of field trials, a Test Facilities GLP compliance is routinely extended to cover remote field sites, as described in 'Scenario 1' in the MHRA guidance on the use of non-GLP facilities, and other documents. Can a UK Test Facility conduct these 'Scenario 1' trials in countries outside of the UK and claim compliance with the UK GLP's assuming that the SD / QA and staff of the Test Facility perform the work in its entirety? As these field sites do not form part of any Test Facility / Site organisation there is no requirement to inform MHRA or national Monitoring Authority as far as I know.
RQA GLP Committee 11/09/2019 16:11
This is quite an unusual situation, we suggest you contact the MHRA labs mailbox and ask for their advice, they will want to know which country the field is in.