ICH M7 Addendum

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] ICH has issued an addendum to its M7 guidance on “assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk” that includes examples of calculations for acceptable intake (AI) and permitted daily exposure (PDE) for 15 compounds commonly used in pharmaceutical manufacturing. The calculations are accompanied by the rationale used to derive them. Also included is an extensive list of publications covering tox studies of each compound. The examples should help firms in implementation of the M7 guideline, which have proven challenging to the industry (see IPQ Monthly Update October 2014, pp. 32-38). The M7 addendum was published in early July as a Step 2 document and is out for comment until January 31, 2016.
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