M7 (R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES
This document from FDA is *unpublished and available for comments . It is scheduled to be published on 04/07/2022.
Can be downloaded from https://public-inspection.federalregister.gov/2022-07395.pdf) PDF version.
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES | FDA
@DAB I see no reference on the document to Nitrosamines Impurities, only monograph added w/ supporting data. Am I missing it?
Hi Naiffer @Naiffer_Host
There’s no specific reference to Nitrosamines in this draft guidance. Monographs and ADIs have been incorporated for compounds which have the potential for forming mutagenic Imps, most of these compounds are employed in drug substance synthesis and some are also included in drug product excipients so this will be a good starting point for assessing and controlling limits from CMC perspective.
Nevertheless, it would be worthwhile to explore possibility of inclusion of ADIs for typical nitrosating agents on same lines as above.
@Naiffer_Host
The Day 1 of Generic Drugs forum 2022 started with a focus on Nitrosamines, Azide Imps and the emphasis on their control strategies both in drug substance and products
Sharing the screen shots
