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Field Trials conducted outside of UK

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  • Anon
    20/08/2019 15:09
    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
    Dear Anon, 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.
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