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The lack of clear standards that would be expected of investigational products was quickly identified as a gap in the EMA guideline [9]. It could be considered that the original intent of the guideline had been to provide guidance on the management of potentially MIs for marketing applications, not for investigational materials, and thus to make good the “gap” in the ICH impurity guidelines. These ICH guidelines, which provide potential registration requirements for marketing applications, point to a potential need for more rigorous control for some impurity classes (e.g. genotoxic impurities) but do not provide guidance on how to manage such impurities. Given this ICH‐driven provenance, one might consider that the Committee for Human Medicinal Products (CHMP) guideline as published was not intended to apply to investigational materials, but like ICH guidelines, to provide potential registration requirements for commercial products. However, the guideline's applicability was ambiguous, and of course with no further specific guidance for investigational materials, it was most likely that the same standards might begin to be applied to investigational materials, even if this was not the initial intent of the expert authors of the original guidance.