EMA, The European Drug Regulator Publishes Draft Guideline on Setting Specifications for Related Impurities in Antibiotics

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Antibiotics active substances currently on the market are produced by chemical synthesis, fermentation or fermentation followed by one or more synthetic steps (semi-synthetic substances). Fermentation processes are, in comparison to synthetic processes, more variable and less controllable, so the impurity profile of an active substance whose manufacturing process involve fermentation may be more complex and less predictable than that of a purely synthetic product. For these reasons fermentation products and semi-synthetic substances are not included in the scope of the ICH Q3 and the VICH 10/11 guidelines, that set thresholds for identification, reporting and qualification of related impurities in active substances manufactured by chemical synthesis.
This guideline has been developed in order to provide guidance on how specifications for related impurities in antibiotics that are fermentation products or semi-synthetic substances derived from fermentation products, therefore not included in the scope of the (V)ICH guidelines mentioned above, should be set.
Thresholds are given in the guideline for reporting, identification and qualification of related impurities for antibiotics medicinal products whose active substance is produced by fermentation or semi-synthesis. For cases where the active substance consists of a mixture of closely related compounds, where it may be difficult to apply general thresholds, general guidance is given on how to set specific thresholds and specifications and how to qualify impurity profiles. The relationships between the requirements in the guideline and the Ph.Eur. applicable chapters and monographs are also addressed.

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