WitrynaICH M7: Mutagenic impurity management expectations. Including evaluation of changes to manufacturing for impact on the quality of drug substance and drug product. Process and controls assessed at approval and through subsequent change. • Other ICH Impurity Guidances • Q3A and B - Impurity management expectations for non … WitrynaThe Empower 3 ICH Impurity Processing function simplifies quantitative analysis by quickly identifying impurities above the ICH allowable limits defined by the user. …
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