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ICH M7 Guide Sets Validation Principles For Genotoxicity Impurity Testing For New Drugs

 
• By Joanne S. Eglovitch

The US FDA has issued a draft question and answer document to the ICH M7 guideline that sheds some light on the validation that needs to be performed before manufactures can rely on the results of computational tests in assessing genotoxic impurities of new drugs.

Mosaic medical test icon and corroded stamp seal with Cancerous text. Mosaic vector is created with medical test icon and with scattered spheric spots. Cancerous stamp seal uses blue color,
ICH Q&A Addresses Validation Principles In Genotoxicity Testing • Source: Shutterstock

The US Food and Drug Administration on 29 September issued a draft question-and-answer document on the International Council on Harmonisation's M7 guideline that specifies the validation principles that pharmaceutical manufacturers should follow when using computational modeling methods for measuring genotoxic impurities in new drugs. These methods will replace in vitro animal tests for assessing impurities.

The Q&A is intended to “clarify, promote the convergence for measuring genotoxic impurities in new drugs, and improve the harmonization” in assessing and controlling DNA reactive, or

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