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Sops and Methods



  • Anon
    16/11/2020 11:33
    Hi, Does anyone have a good way to distinguish between a SOP and a Method? Thanks
  • RQA GLP Committee
    20/11/2020 09:40
    Dear Anon, Generally speaking SOPs would support a range of studies i.e Use of balances is not specific to any study type or client, whereas a method is normally specific to one study, one study type, or a small number of studies utilising the same test item or for the same sponsor. Methods may become SOPs if this is appropriate. However, methods should be controlled, and reviewed as any other controlled document.
  • RQA GLP Committee
    20/11/2020 14:37
    Dear Anon, Further to the earlier answer, it should be remembered that the word 'Standard' is what separates SOPs from methods, but you should have a SOP for control of SOPs and a SOP for control of methods. Methods may have a different approval process from SOPs however.
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