ICH guideline M7 assessment and control of DNA
reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic
risk.
Q&A Step 2b Since the ICH M7 Guideline was
finalized, worldwide experience with implementation of the recommendations for
DNA reactive (mutagenic) impurities has given rise to requests for
clarification relating to the assessment and control of DNA reactive
(mutagenic) impurities.
The Q&A document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files.
The scope of the Q&A document follows that of ICH
M7. “Applicant” is used throughout the Q&A document and should be
interpreted broadly to refer to the marketing authorization holder, the filing
applicant, the drug product manufacturer, and/or the drug substance
manufacturer.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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