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Test Article Characterization Requirement of an ethanolic extract of a grounded test article



  • anon
    24/09/2020 09:49
    Hi, I am interested in knowning test article characterization requirement, as per FDA GLP CFR 21, part 58, for an ethanolic extract of a grounded test article that is to be used for in vitro study. If I have a CoA of the grounded test article, is that sufficient to meet the characterization requirement or will I need the characterization data of the actual extract so as not have deviation from GLP compliance? I have read the guidance over and over but have not been able to understand how to approach in my situation and any information will be appreciated.
  • RQA GLP Committee
    19/11/2020 15:21
    Dear Anon, You need to define what the test item is. If the ethanolic extract is going to be the test item, then it is this that will need to be characterised. If the extract is the way the test item is prepared to be administered to the test system then concentration, stability etc. information will be needed. If the extract is what is defined as the test item and what is applied to the test system, then that will need to be characterised. Depending on where you are in the World and what your plans are for the study results, the FDA requirements may not be relevant, but if your are in an OECD member country then you should follow the OECD requirements.
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