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

Executive Summary

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.

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The pharmaceutical industry is concerned about the cost involved in setting up complex computational systems required for evaluating potential genotoxic impurities in drug substances and drug products under ICH M7. The guidance goes into effect in January 2016 for drugs in clinical development and in July 2017 for new and generic drug applications as well as drugs with post-approval changes.

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...by industry and regulators are heading toward internationally harmonized solutions to the challenges involved. In view of more temperature-sensitive products and a more complex distribution chain, FDA and other regulatory agencies are working to develop and implement effective guidance and oversight in conjunction with industry and pharmacopeia efforts to develop viable, globally-relevant standards. Key temperature control issues include: ** how much monitoring is appropriate ** allowable excursions during transportation, and ** how to qualify the distribution process. [A discussion by an FDA compliance official of the initiative under way at the agency to assess cold chain problems and better target its regulatory response is provided.]

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